It came to a surprise to me that some pharma manufacturers, especially OTC, are still not aware of the needs to conduct process validation... Our DCA has made this compulsory for product registration in stages since last year.
Being not aware is one problem.... Being ignorant is worse..! Manufacturer's should take effort to equip their personnel with the required knowledge and skills. Process validation is not only meeting GMP requirements and ensuring your GMP license remain valid. It is much more than that.
With validated process, you can rest assure that you have good control and your process, and able to consistently produced output that meets the quality criteria you have pre-determined. You will have peace of mind.
In a world where patients are now knowledgable and more demanding, this is one aspect of GMP you cannot do away with...!
AJ.
Monday, December 7, 2009
Saturday, October 17, 2009
PharmScience Newsleter
I personnally do not know him but I find this guy, Lex Rudd, a very generous man. Wonder if he got any relationship with the Australlian PM...... ;-)
N'way, visit his site at http://www.pharmscience.com.au/ and subscribe to his newsletter at no cost. You will find that Lex share with us numerous helpful tips and info on GMP matters.
Not enough? Need to know more? Contact him for a GMP training.
Thanks Lex.
AJ.
Thursday, October 15, 2009
MSc in Industrial Pharmacy
The Kulliyah of Pharmacy, Islamic International University of Malaysia (IIUM), plans to provide a master program in Industrial Pharmacy by year 2010. This will be a 15 months course work to equip students with the basic needs for practising in the pharmaceutical industry.
I find this program suitable for those who wish to venture into industrial pharmacy and those already in the industry but wish to equip themselves with the relevant knowledge as a career advancement. To be eligible, you must have at least first degree in science related field.
The program is meticulously designed for the pharma industry. Interestingly, IIUM even adds in one module on Management, which will expose students to the various stuff in management, finance, costing, conflict management, project management etc… You will also be able to take the elective courses on specific subject matters such as Logistics, Natural Medicinal Products, Vaccines, Biomaterial development & medical devices.
For manufacturers, it is good if you can sponsor your competent (and loyal) staff for this program. You will just have to spare him/her for 10-11 months with the balance practical training conducted in your own facility. Good eh?
My only wish is for this program to be industry-friendly, ie. Lectures should be scheduled on weekends to enable working students to participate. There should be assignments and self-studies in addition to attending lectures and practicals.
If you wish to know more, just call Dr Kausar at 09-5716681 (email: kausar.ahmad@gmail.com), or Mdm Juliana at 09-5716400 ext 268 (email: juliekz@msn.com). You can also contact me....!
There's only 10 places for the first year. I guess it will be first come first serve basis.
AJ.
I find this program suitable for those who wish to venture into industrial pharmacy and those already in the industry but wish to equip themselves with the relevant knowledge as a career advancement. To be eligible, you must have at least first degree in science related field.
The program is meticulously designed for the pharma industry. Interestingly, IIUM even adds in one module on Management, which will expose students to the various stuff in management, finance, costing, conflict management, project management etc… You will also be able to take the elective courses on specific subject matters such as Logistics, Natural Medicinal Products, Vaccines, Biomaterial development & medical devices.
For manufacturers, it is good if you can sponsor your competent (and loyal) staff for this program. You will just have to spare him/her for 10-11 months with the balance practical training conducted in your own facility. Good eh?
My only wish is for this program to be industry-friendly, ie. Lectures should be scheduled on weekends to enable working students to participate. There should be assignments and self-studies in addition to attending lectures and practicals.
If you wish to know more, just call Dr Kausar at 09-5716681 (email: kausar.ahmad@gmail.com), or Mdm Juliana at 09-5716400 ext 268 (email: juliekz@msn.com). You can also contact me....!
There's only 10 places for the first year. I guess it will be first come first serve basis.
AJ.
Saturday, October 10, 2009
Importance of good documentation in GMP
Everybody knows that documentation is critical in GMP, but not Anybody can assure of a good structured system of documentation to supplement the good process and GMP control in the facility.
Somebody need to be in the reign to control and monitor GMP documents and not leave it to Anybody to do it, cause it will end up with Nobody doing anything on documentation.....
[just relating the story of the 4 persons; Nobody, SOmebody, Anybody and Everybody...]
GMP licensed facility are regualrly audited by the government GMP auditors on a periodic basis. These audits vary from one day to 3 days, and by one auditors to as many of 9 auditors! Auditors do not waste their time to scrutinize all the operations steps and process controls being carried out by operational staff. However, they spend more time on scrutinizing documents; on schedules, SOPs, work instructions, records, log books, test data, calibration certificates, and any form of document that will help them evaluate and access the level of compliance.
We used to joke that GMP is "Generate More Papers", and this seems true in reality. We have tons of documents to handle. As operation get more complex, we have more documents to cater to... However, there should be no excuse if you are not able to retrieve the particular records required by auditors during their audit. Anything more than 30 minutes to retrieve a particular record will be deemed that you have underlying 'problems' in your document control procedures; and this leads to the procedure being scrutinized.
So, my piece of advice, do not ignore and take your current document system for granted. Look into the details and ensure that you have a well structured and organized document system that is being followed by everyone in the organization.! Get help if you are sure where you stand.
Good luck.
AJ.
Somebody need to be in the reign to control and monitor GMP documents and not leave it to Anybody to do it, cause it will end up with Nobody doing anything on documentation.....
[just relating the story of the 4 persons; Nobody, SOmebody, Anybody and Everybody...]
GMP licensed facility are regualrly audited by the government GMP auditors on a periodic basis. These audits vary from one day to 3 days, and by one auditors to as many of 9 auditors! Auditors do not waste their time to scrutinize all the operations steps and process controls being carried out by operational staff. However, they spend more time on scrutinizing documents; on schedules, SOPs, work instructions, records, log books, test data, calibration certificates, and any form of document that will help them evaluate and access the level of compliance.
We used to joke that GMP is "Generate More Papers", and this seems true in reality. We have tons of documents to handle. As operation get more complex, we have more documents to cater to... However, there should be no excuse if you are not able to retrieve the particular records required by auditors during their audit. Anything more than 30 minutes to retrieve a particular record will be deemed that you have underlying 'problems' in your document control procedures; and this leads to the procedure being scrutinized.
So, my piece of advice, do not ignore and take your current document system for granted. Look into the details and ensure that you have a well structured and organized document system that is being followed by everyone in the organization.! Get help if you are sure where you stand.
Good luck.
AJ.
Wednesday, October 7, 2009
GMP Documentation Training, 5 to 6 Oct 09
This training was organized by Malaysian Biotechnology Corporation for Bio-Nexus status companies. And it was free of charge! Training done at Istana Hotel - good environment and good food...... En Lukmani from the GMP Compliance div. of NPCB came to give the first paper and the rest by A1 Consultancy.
We expected only 20 participants but ended up with more than 30!
Many critical documentation matters were discussed including validation. The wide diversification of participants; from those very fresh in GMP to those already seasoned, made it difficult to strike a balance on the level of knowledge to impart.
Anyway, it was a beneficial training session to all participants. Thanks to Msian BioTech Corp for the great effort!
AJ.
Thursday, September 10, 2009
GMP Audit
It is year end and the GMP auditors should now be busy meeting their surveillance schedule. GMP license holders should now be ready for such audit as these audits are on a surprise basis. We do not want you to be 'surprised' and faced with a compulsory shut down..!
I know most of the managers shiver thinking of the coming audit, but it is actually not that difficult to prepare for an audit. Why should you when you know that you have all in place...?
Important things to do is to check that your facility and equipment are in order with no severe defects. Ensure that documents and records are up to date and in order. Ensure that materials/products in warehouse and in production areas are well segregated, identified and protected. Hygience and cleanliness taken care of. Training of staff done as per training program. Self audit done, recorded and corrective actions taken. And many other routine things.....
A self audit will definitely helps in probing and uncovering any 'unturned stones'. This is best done by person not from that department, and better from outside the facility. Such person will have a look at your facility from a different angle and without bias. I am not promoting that you enagage us as an external auditors, but those who have done so did benefit from this service. Those in the facility are used to see 'non-compliance' happening right in front of their eyes and yet 'believing' it to be okay..... it's just like a normal thing.... they become 'immune' (if you know what I mean...)
However, external auditors can easily see such 'non-compliances'. Coupled with their experience at other facilities, such non-complaince can be easily spotted and proposed corrective actions can also be extended by these external auditors.
Whatever it is, always planned for a GMP audit and do not be taken by surprise. If you can have a well organized plan in case of fire, why not have one for a GMP audit....?
Good luck!
AJ.
I know most of the managers shiver thinking of the coming audit, but it is actually not that difficult to prepare for an audit. Why should you when you know that you have all in place...?
Important things to do is to check that your facility and equipment are in order with no severe defects. Ensure that documents and records are up to date and in order. Ensure that materials/products in warehouse and in production areas are well segregated, identified and protected. Hygience and cleanliness taken care of. Training of staff done as per training program. Self audit done, recorded and corrective actions taken. And many other routine things.....
A self audit will definitely helps in probing and uncovering any 'unturned stones'. This is best done by person not from that department, and better from outside the facility. Such person will have a look at your facility from a different angle and without bias. I am not promoting that you enagage us as an external auditors, but those who have done so did benefit from this service. Those in the facility are used to see 'non-compliance' happening right in front of their eyes and yet 'believing' it to be okay..... it's just like a normal thing.... they become 'immune' (if you know what I mean...)
However, external auditors can easily see such 'non-compliances'. Coupled with their experience at other facilities, such non-complaince can be easily spotted and proposed corrective actions can also be extended by these external auditors.
Whatever it is, always planned for a GMP audit and do not be taken by surprise. If you can have a well organized plan in case of fire, why not have one for a GMP audit....?
Good luck!
AJ.
Sunday, September 6, 2009
Facility qualification of a new manufacturing plant
It really is a burden when asked to qualify a new plant that is almost completed...!
I have this unfortunate incidence whereby the owner requested for my service to qualify their plant, after the 'qualification' done by their respective supplier was found not to be in compliance to GMP.
Suppliers are not to be blamed. I blamed the M&E consultant for their ignorance in differentiating the 'qualification' needs between Good Engineering Practise (GEP) and GMP and highlighting it to the appointed contractor/supplier. The documentation needs and focus required by GMP is different from GEP. While GEP focus on the capability and safety of the facility, GMP focus more on the performance and ability to maintain product integrity and quality. Some (if not most) of the activities overlap. A well prepared qualification plan will cunningly make use of what's done under GEP to incorporate into qualification as required by GMP.
The recent ISPE conference in Singapore highlighted this matter in their pre-conference workshop and even provide examples on how this can be effectively done. To me, this is logic which should have been adopted much earlier if not for the 'narrow mindness' of some practitioner that GEP is a total separation from GMP.
Having said all that, the qualification of facility is still laborious and time consuming. The delay in initiating this effor, concurrent with the commission done by suppleir, will further aggravate the problem one have to face.
How I wish this qualification job was 'given' earlier to me as their GMP consultant, rather than entrusting it to the supplier....... but how can I reject...?
AJ.
I have this unfortunate incidence whereby the owner requested for my service to qualify their plant, after the 'qualification' done by their respective supplier was found not to be in compliance to GMP.
Suppliers are not to be blamed. I blamed the M&E consultant for their ignorance in differentiating the 'qualification' needs between Good Engineering Practise (GEP) and GMP and highlighting it to the appointed contractor/supplier. The documentation needs and focus required by GMP is different from GEP. While GEP focus on the capability and safety of the facility, GMP focus more on the performance and ability to maintain product integrity and quality. Some (if not most) of the activities overlap. A well prepared qualification plan will cunningly make use of what's done under GEP to incorporate into qualification as required by GMP.
The recent ISPE conference in Singapore highlighted this matter in their pre-conference workshop and even provide examples on how this can be effectively done. To me, this is logic which should have been adopted much earlier if not for the 'narrow mindness' of some practitioner that GEP is a total separation from GMP.
Having said all that, the qualification of facility is still laborious and time consuming. The delay in initiating this effor, concurrent with the commission done by suppleir, will further aggravate the problem one have to face.
How I wish this qualification job was 'given' earlier to me as their GMP consultant, rather than entrusting it to the supplier....... but how can I reject...?
AJ.
Friday, August 21, 2009
Kotra Pharma's new facility
I was passing by Cheng Industrial Estate Melaka, and was amazed to see the progress in Kotra Pharma new facility. It is such a huge 'state-of the art' facility, and multi storey. How I wish the management may open up their facility for us to visit before it is commissioned......
This is Kotra Pharma's existing plant. Already a big one.....
Now you only see 50% of the building
This is Kotra Pharma's existing plant. Already a big one.....
Now you only see 50% of the building
.
This is their new plant. Still under construction. This is only the front view... The facility looks 4 times bigger from side.
Wish all the best to staff and management of Kotra Pharma Sdn Bhd.
AJ.
Monday, August 17, 2009
Qualification required for secondary packager
You may not realize this but the activity of filing is still regarded as a critical processing area where the products are exposed and open to risk of cross-contamination. Secondary packager may not be involved in the manufacture of products, however, they are still required to validate their HVAC system for the filling process.
Water used for final rinsing of contact parts must also be of Purified water grade, BP or USP and related equipment be qualified.
Without compliance to the above, you may only be licensed for the packaging of herbal/traditional products and health supplements.
=(
AJ.
Water used for final rinsing of contact parts must also be of Purified water grade, BP or USP and related equipment be qualified.
Without compliance to the above, you may only be licensed for the packaging of herbal/traditional products and health supplements.
=(
AJ.
Saturday, August 8, 2009
Cosmetic notification wih DCA
To those who have submitted notification but not remit your payment...... beware as the authority has declared that any payment not remitted before 15 August 2009 will face the wrath of DCA.
You will not be punished, but your submission will be withdrawn or rejected.
No big deal...? If you have a long list of ingredients in your formula, you will know the pains of entering these data.
Well... most of the paymasters are not the same person entering these data into Quest2. So, why bother....? At least, some people will be kept occupied re-entering the notification data.
AJ.
You will not be punished, but your submission will be withdrawn or rejected.
No big deal...? If you have a long list of ingredients in your formula, you will know the pains of entering these data.
Well... most of the paymasters are not the same person entering these data into Quest2. So, why bother....? At least, some people will be kept occupied re-entering the notification data.
AJ.
Saturday, July 25, 2009
Lab Asia 2009
Do you know that Lab Asia 200 is coming soon to PWTC, KL. It'll be open from 11 to 13 August 2009.
This is the place if you are searching for suitable instruments and analytical tools for your qualty control lab. You will also be able to view and experience any new technologies introduced.
To know more, go to http://www.lab-asia.com/asia/index.html
And block your diary to ensure you do not miss this golden oppotunity.
HVAC qualification by supplier/contractor
In pharma industry, any new installation or major upgrading of HVAC (Heating, Ventilation and Air Conditioning) servicing the processing area requires qualification.
Seems to me that most of our pharma industries adopt a safe attitude by requiring qualification as part of the requirements which a potential supplier or contractor has to comply. This trigger the supplier or contractor to look for a GMP consultant and work with them on the qualification work. Thus, it goes on that the Qualification Plan, URS, DQ, IQ and OQ protocols and reports are all being prepared between the GMP consultant and the supplier. Occasionally, the user is approached for some verification and signatures.
However, this is not a healthy scenario. Industries should be the party directly responsible for the qualification work. If they do not have the expertise, engage a GMP Consultant under them - do not let the GMP consultant be under the 'control' of the supplier.
The reason I say this is due to the fact that the qualification actually ensures that the work done by the supplier or contractor met the approved design and GMP requirements. If the GMP consultant is under the control of the supplier or contractor, he will find difficulty in conveying the problem to the supplier. Worst, if any part cannot be approved (or qualified), the GMP Consultant will face the wrath of the supplier...! How can he then ensure that the HVAC system be well constructed and supplier/contractor do not cut corners....?
Think about it and in your next project, do not allow the GMP consultant to be working under the supplier or contractor.
AJ.
Seems to me that most of our pharma industries adopt a safe attitude by requiring qualification as part of the requirements which a potential supplier or contractor has to comply. This trigger the supplier or contractor to look for a GMP consultant and work with them on the qualification work. Thus, it goes on that the Qualification Plan, URS, DQ, IQ and OQ protocols and reports are all being prepared between the GMP consultant and the supplier. Occasionally, the user is approached for some verification and signatures.
However, this is not a healthy scenario. Industries should be the party directly responsible for the qualification work. If they do not have the expertise, engage a GMP Consultant under them - do not let the GMP consultant be under the 'control' of the supplier.
The reason I say this is due to the fact that the qualification actually ensures that the work done by the supplier or contractor met the approved design and GMP requirements. If the GMP consultant is under the control of the supplier or contractor, he will find difficulty in conveying the problem to the supplier. Worst, if any part cannot be approved (or qualified), the GMP Consultant will face the wrath of the supplier...! How can he then ensure that the HVAC system be well constructed and supplier/contractor do not cut corners....?
Think about it and in your next project, do not allow the GMP consultant to be working under the supplier or contractor.
AJ.
Microbial test for Purified Water
The latest BP method is by microbial filtration, utilizing a sample size of 100ml.
I find this method as not suitable compared to the older method of pour plate using 0.1 to 1.0ml sample.
Consider the fact that microbial limit for Purified Water is 100 cfu/ml. If you have 10 cfu/ml, a sample of 100ml will show you a result of 10 x 100 = 1000 cfu. Can you count this much cfu..? What if your sample is 20 cfu/ml, or more....?
Thus, a sample size of 1ml using pour plate method will neatly fit this situation. Most samples o Purified Water will be more than 10 cfu/ml and this will show well on the agar plate.
However, if you consistently achieved a level of less than or equal to 1 cfu/ml, then you should adopt the new method using microbial filtration and sample size of 100ml.
Anyone out here having problems with microbial test on Purified water that you can share..?
We'd like to hear form you!
AJ
I find this method as not suitable compared to the older method of pour plate using 0.1 to 1.0ml sample.
Consider the fact that microbial limit for Purified Water is 100 cfu/ml. If you have 10 cfu/ml, a sample of 100ml will show you a result of 10 x 100 = 1000 cfu. Can you count this much cfu..? What if your sample is 20 cfu/ml, or more....?
Thus, a sample size of 1ml using pour plate method will neatly fit this situation. Most samples o Purified Water will be more than 10 cfu/ml and this will show well on the agar plate.
However, if you consistently achieved a level of less than or equal to 1 cfu/ml, then you should adopt the new method using microbial filtration and sample size of 100ml.
Anyone out here having problems with microbial test on Purified water that you can share..?
We'd like to hear form you!
AJ
GMP Consultant = Consultant Engineer ?
I had this peculiar encounter with a bunch of consultant engineer (M&E and C&S), plus an architect. I have submmited a conceptual layout on the location for dainages and separate them between those to be directed to a sewerage system and another to a waste treatment sump (as required by Dept. of Environment).
Seems this is not enough.... They want me to provide the draine slopes, the pipe details (size and materials), exact X-Y positions of the drain holes and presented in an auto-cad drawing with scale 1:200!
If I'm able to do all these, I might as well assume the position of an M&E consultant and charge a higher fee !
Actually, GMP Consultants provide only the conceptual design of the facilities and utilities, whereas the Consultant Engineers provide technical and engineering input. For example, a GMP consultant provide the HVAC requirements specifications, but the engineers will calculate and size the required equipments and provide the technical drawings for construction.
Yes, that's how we can work as a better team..!
Got it...??
AJ
Seems this is not enough.... They want me to provide the draine slopes, the pipe details (size and materials), exact X-Y positions of the drain holes and presented in an auto-cad drawing with scale 1:200!
If I'm able to do all these, I might as well assume the position of an M&E consultant and charge a higher fee !
Actually, GMP Consultants provide only the conceptual design of the facilities and utilities, whereas the Consultant Engineers provide technical and engineering input. For example, a GMP consultant provide the HVAC requirements specifications, but the engineers will calculate and size the required equipments and provide the technical drawings for construction.
Yes, that's how we can work as a better team..!
Got it...??
AJ
Anyone dumb for a chocolate..?
This is not GMP matters. It just that a friend adviced me, or any other Malaysia, from eating this chocolate as it may make you dumb.I know how far this is true. Maybe for fellow Malaysian only..... This chocolate named 'Bahloul', comes from an Arab country.
Any one for a BAHLOUL choc...!
Lecture at new Kulliyah Pharmacy, IIUM
I gave my lecture on tablet processing at the new building of Kulliyah Pharmacy, IIUM, Kuantan on 20-Jul-09. It sure was a grand experience.
Although not fully ready, I can say that the occupants simply 'barge' in and make it their home. What better ways to force contractors to complete their work.....? I salute you guys..!
Finally, the Pharmacy faculty has their own building. They have been sharing with the Medicine faculty all this while, and having one will means a higher number of students intake from now on.
Well... being new, many things are still in a mess. Lecture halls are spacious and grand, but computers was not equipped with a monitor for lecturer to see. I had to turn my head to view what's on the screen. Thank God my lecture was only for 2 hours. Anything more will land me with a neck sprain.!
I know Dr Mohamad Awang is doing his best to get all this sorted out.
One good outcome to the inhabitants of this Kulliyah Pharmacy (as what I heard...) from this event is that many have managed to slim down to a perfect figure..!
AJ.
Sunday, July 12, 2009
Registration of Veterinary medicine
The dateline for submitting existing veterinary product recently ended on 30-Jun-09.
Many were frustrated at no being able to meet this dateline. There were many documents unavailable and getting them is a real tough job. Documents such as certificate of free sale, and GMP manufacturing license, as well as stability study and materials certificate of analysis..... all these presented problem to the submission process.
However, don't despair... You are still able to submit these products after the dateline. The only difference is you will not be able to enjoy the privilege given to those submitted before the dateline.
Those products will obtain the status as "Existing product" and can continue to be in the market while their submission undergo evaluation.
Non-existing product cannot be in the market until approved by DCA. If found to do so, you may be found guilty and have to pay a penalty for this.
Got it...?
AJ
Many were frustrated at no being able to meet this dateline. There were many documents unavailable and getting them is a real tough job. Documents such as certificate of free sale, and GMP manufacturing license, as well as stability study and materials certificate of analysis..... all these presented problem to the submission process.
However, don't despair... You are still able to submit these products after the dateline. The only difference is you will not be able to enjoy the privilege given to those submitted before the dateline.
Those products will obtain the status as "Existing product" and can continue to be in the market while their submission undergo evaluation.
Non-existing product cannot be in the market until approved by DCA. If found to do so, you may be found guilty and have to pay a penalty for this.
Got it...?
AJ
Sunday, July 5, 2009
Vet, oh vet.........
Now that the dateline for registration of veterinary medicines is over, I can divert my focus to my routine jobs. Things were abnormal during submission of the vet medicines before the dreaded due date.
Now need to focus on the plant design and construction of vet medicinal manufacturers. Got a small handful of jobs on this, but enough to keep me busy and survive....
Although the standards to be followed by vet manufacturer is still the same PIC/S GMP guidance, Annex 4 of the guidance allows some leniency in the facility design. For instance, vet manufacturers are allowed to manufacture beta-lactam products in the same facility as other products, provided it is done on a campaign basis and efforts taken to ensure effective removal of any beta-lactam residues before the change over to another product.
Annex 4 also allows manufacture of sterile products be done in a lower grade than human sterile medicines, but not lower than Grade D. Well...... that's fair enough.
However, I am still amazed with the requirements to fully comply with the pharma standards for water system....... Yes, we may comply to this, but just give a second thought on what the animals eat or drink after consuming these 'high standard' medicines...? Yes, they go back to the usual hay, or feed, etc, all from the usual receptacles, and may drink from a trough, river or pond.... That sure has much higher level of impurities and microbes!
Just give that second thought.....
AJ.
Now need to focus on the plant design and construction of vet medicinal manufacturers. Got a small handful of jobs on this, but enough to keep me busy and survive....
Although the standards to be followed by vet manufacturer is still the same PIC/S GMP guidance, Annex 4 of the guidance allows some leniency in the facility design. For instance, vet manufacturers are allowed to manufacture beta-lactam products in the same facility as other products, provided it is done on a campaign basis and efforts taken to ensure effective removal of any beta-lactam residues before the change over to another product.
Annex 4 also allows manufacture of sterile products be done in a lower grade than human sterile medicines, but not lower than Grade D. Well...... that's fair enough.
However, I am still amazed with the requirements to fully comply with the pharma standards for water system....... Yes, we may comply to this, but just give a second thought on what the animals eat or drink after consuming these 'high standard' medicines...? Yes, they go back to the usual hay, or feed, etc, all from the usual receptacles, and may drink from a trough, river or pond.... That sure has much higher level of impurities and microbes!
Just give that second thought.....
AJ.
Labels for Health Supplements
It was one week since I last blog. I have many issues to write but this one really stunned me.Some of you may have received this circular from NPCB, dated 16-Jun-09, requiring that certain information be located at a stipulated location on the label. See attached draft.
I do no doubt the benefits to consumers, but I feel this restrict the creativity by the product owners...
Label shape can varies, graphics definitely differ, and all these will impose high restrictions in designing of the product labels.
Such restrictions may be good for the medicinal drugs, but for health supplements...???
I am surprised that the industries have no objection to this ruling. I forsee tremendous havoc with registration of imported products. Well, let's see how it goes.....
AJ.
Monday, June 29, 2009
Industrial Pharmacy in Universities
Universities are now offering courses in Industrial Pharmacy in their syllabus.
I salute this effort as the industries has long been waiting for pharmacists with such skill and knowledge. Currently, industries have to 'adopt' the fresh graduate and train them in all aspects of industrial knowledge, especially on the GMP requirements. Where can you get 'free' training and being paid a handsome salary at the same time...!?
The sad thing is these 'lucky' pharmacists will just leave the company when offered a better pay job... although it is non-industrial related. All the time and effort spent is wasted, just like that. This is not cost effective at all to the industries.
Some of you may not realise that universities teaching industrial pharmacy have a big restriction, ie. getting their students to do practical work. Currently, they depend on local industries giving few places to their students. But how many of these industries are kind enough to do so......? We have many universities now offering this course and each with more than 50 students. Even if all the GMP aproved industries accepting 4 students; this is still inadequate for the universities' need. What more now with only a handful of these 'kind' industries around...?
One good university, International Islamic Univeristy of Malaysia has put forward a bold plan to set up their own GMP plant - just to ensure that their students will be trained in a GMP aproved facility. What a move..... Thanks to the NPCB's ful cooperation, this plant is almost completed and should be ready for legal use next year.
Other universities are following suit.... I know University Technology MARA is already setting up plans to have their own GMP approved facility at their new Puncak Alam site. Bravo to these universities.....!
And to the industries, give your lending hand until all universities can depend on their own GMP approved facilities.
AJ.
I salute this effort as the industries has long been waiting for pharmacists with such skill and knowledge. Currently, industries have to 'adopt' the fresh graduate and train them in all aspects of industrial knowledge, especially on the GMP requirements. Where can you get 'free' training and being paid a handsome salary at the same time...!?
The sad thing is these 'lucky' pharmacists will just leave the company when offered a better pay job... although it is non-industrial related. All the time and effort spent is wasted, just like that. This is not cost effective at all to the industries.
Some of you may not realise that universities teaching industrial pharmacy have a big restriction, ie. getting their students to do practical work. Currently, they depend on local industries giving few places to their students. But how many of these industries are kind enough to do so......? We have many universities now offering this course and each with more than 50 students. Even if all the GMP aproved industries accepting 4 students; this is still inadequate for the universities' need. What more now with only a handful of these 'kind' industries around...?
One good university, International Islamic Univeristy of Malaysia has put forward a bold plan to set up their own GMP plant - just to ensure that their students will be trained in a GMP aproved facility. What a move..... Thanks to the NPCB's ful cooperation, this plant is almost completed and should be ready for legal use next year.
Other universities are following suit.... I know University Technology MARA is already setting up plans to have their own GMP approved facility at their new Puncak Alam site. Bravo to these universities.....!
And to the industries, give your lending hand until all universities can depend on their own GMP approved facilities.
AJ.
Thursday, June 25, 2009
Is consultant a nuisance to regulators...?
Some of you may think so.... but think again.... On contrary, we consultants make life easier for the regulators.Not all the manufacturers and importers are well versed with the laws and guidelines as laid down by the government and Drug Control Authority. Understanding them is one problem, and with lack of experience in this field, the problem multiplies.
I can see the regulators' sincere needs to get the manufacturers and importers fully involved in the regulatory issues. But how far can they go? Can't this be better achieved with a good consultant besides you?
The manufacturers and importers are by priority an enterpreneur. They have buisness as a priority to take care - without which they'll simply go bust!
Infact, a smart entreprenuer will just engage a consultant to look into their regulatory matters. It as simple as emplyoing a full time staff for this job. But, by engaging a consultant, (not on the company pay list) these enterprenueurs are able to choose the most competent and reliable consultants, whom they can quickly replaced if the consultant do not perform. Kicking out an internal staff is a lot more dramatic and cumbersome.
In business, a consultant is a good solution to these businessmen who lacks the knowledge and experience in regulatory issues. For regulators, these consultants helps to trim down all the regulatory problems the enterpreneurs faced and left to deal only on important matters with the regulators. Life becomes easier for both, right? Consultant merely act as a bridge to these 2 parties. Isn't it wonderful...?
So, don't discourage this arrangement by requiring the enterpreneurs themselves to put forward their technical problems to the regulators, presenting them and providing solutions - these are the job for the appointed consultants.
Some enterpreneurs have cold feet when in discussion with the regulators.....!
If all the enterpreneurs are able to do that, we consultants need to switch job and get involved in a new trade...... like selling fried kuay teow.....
If all the enterpreneurs are able to do that, we consultants need to switch job and get involved in a new trade...... like selling fried kuay teow.....
Friday, June 12, 2009
Busy.... busy.... busy......
Wow... These few days were very busy with work.
To make matters worse, veterinary products must be submitted for registration before 30-June-2009. And some of my clients just hand over their handful products last week....! I have to decline for those who just requested me to register for them. I am sure there are some other consultants with adequate resources to handle them.
Another matter that worsen this 'busy' state of mine is the Quest2. The program is so slow that you literally have to wait and stare at your screen, hoping to see the much awaited 'Downloaded successful!". This situation is aggravated in the day, during office hours. How I wish Quest2 is able to accomodate high traffics. This happen Dec last year when the dateline for vet products was supposed to be 31 Dec 08. Sometimes, technology do have its set back. If this is manual, I would have handed over all the dossiers by end next week.
That's life.
To make matters worse, veterinary products must be submitted for registration before 30-June-2009. And some of my clients just hand over their handful products last week....! I have to decline for those who just requested me to register for them. I am sure there are some other consultants with adequate resources to handle them.
Another matter that worsen this 'busy' state of mine is the Quest2. The program is so slow that you literally have to wait and stare at your screen, hoping to see the much awaited 'Downloaded successful!". This situation is aggravated in the day, during office hours. How I wish Quest2 is able to accomodate high traffics. This happen Dec last year when the dateline for vet products was supposed to be 31 Dec 08. Sometimes, technology do have its set back. If this is manual, I would have handed over all the dossiers by end next week.
That's life.
Sunday, June 7, 2009
GMP for Veterinary Medicinal Manufacturers
Time flies, and it's now almost to the dateline for registration of verterinary medicines. The last date is 30 June 2009, which is less than one month away.
As part of registration requirements, local manufacture need to produce at least a Letter of GMP Compliance, although some say that a letter of submission for plant GMP layout will suffice.
The pertinent issue of concern to many is the needs for GMP compliance for manufacturing sites, producing veterinary medicines. While few have obediently initiated work to set up a GMP compliant facility, many still adopt the 'wait-and-see' stance. I don't know what are these people waiting for..... GMP is there to stay and be implemented as per schedule.
Yes, the needs to comply to GMP will incur high investment cost. This will undoubtly hinders the noble effort by our Ministry of Health (MoH) to ensure GMP compliance to all manufacturers. However, I feel the MoH should also lent an ear to these group of people. Cost is always a problem and it is easier said than done that these manufacturers must put in all effort in obtaining GMP compliance, or have their products withdrawn from the market.
I remember when we started GMP for the human medicinal products, way back in year 1987. Ample time were given to introduce GMP and more time given for the players to upgrade from a lower level to the high level of GMP that we have adopted now.
I hope the same can be accorded to these vet medicinal manufacturers.
It's good that validation is not compulsory, but the authority seems to require some form of 'verification'. And at to what level this 'verification' is needed was not clearly stated.
Another issue is the water requirement. Imposing that the water must comply to BP and USP can be an extremely expensive affair. Why not follow the same specs for manufacturers of herbal and traditional medicines? Give them say 3 - 5 years and impose these requirements later, when they have settled down with the infrastructure and operation system.
Other issues will be like material sampling and evaluation, in-process controls, environmental air quality, and stability studies. These are critical issues, but just allow them to focus on the basic issues like facility, personnel and documentaion as a start.
I understand the needs for a high quality products to ensure safety to human, especially for drugs used on animals that will be consumed by humans. But it also can be 'contradicting' when one realize that these animals will also consume their food from ground, some eat grass from the fields and most drinks from lakes, streams and drains....
Give a tinker on the above and extend some mercy to these vet medicinal manufacturers, at least for these few years.....
AJ.
As part of registration requirements, local manufacture need to produce at least a Letter of GMP Compliance, although some say that a letter of submission for plant GMP layout will suffice.
The pertinent issue of concern to many is the needs for GMP compliance for manufacturing sites, producing veterinary medicines. While few have obediently initiated work to set up a GMP compliant facility, many still adopt the 'wait-and-see' stance. I don't know what are these people waiting for..... GMP is there to stay and be implemented as per schedule.
Yes, the needs to comply to GMP will incur high investment cost. This will undoubtly hinders the noble effort by our Ministry of Health (MoH) to ensure GMP compliance to all manufacturers. However, I feel the MoH should also lent an ear to these group of people. Cost is always a problem and it is easier said than done that these manufacturers must put in all effort in obtaining GMP compliance, or have their products withdrawn from the market.
I remember when we started GMP for the human medicinal products, way back in year 1987. Ample time were given to introduce GMP and more time given for the players to upgrade from a lower level to the high level of GMP that we have adopted now.
I hope the same can be accorded to these vet medicinal manufacturers.
It's good that validation is not compulsory, but the authority seems to require some form of 'verification'. And at to what level this 'verification' is needed was not clearly stated.
Another issue is the water requirement. Imposing that the water must comply to BP and USP can be an extremely expensive affair. Why not follow the same specs for manufacturers of herbal and traditional medicines? Give them say 3 - 5 years and impose these requirements later, when they have settled down with the infrastructure and operation system.
Other issues will be like material sampling and evaluation, in-process controls, environmental air quality, and stability studies. These are critical issues, but just allow them to focus on the basic issues like facility, personnel and documentaion as a start.
I understand the needs for a high quality products to ensure safety to human, especially for drugs used on animals that will be consumed by humans. But it also can be 'contradicting' when one realize that these animals will also consume their food from ground, some eat grass from the fields and most drinks from lakes, streams and drains....
Give a tinker on the above and extend some mercy to these vet medicinal manufacturers, at least for these few years.....
AJ.
Thursday, June 4, 2009
Visit to Norvatis Singapore
The plant visit organized by ISPE yesterday was really informative. I went to visit Norvatis plant in Tuas, Singapore. This plant currently manufactured tablet products.
But oh my.... the extent of technology and controls put in was simply fabulous and I felt lucky to be able to experience it.
Handling of materials was given great emphasis and Norvatis practise a close system as far as they can. Such plant by a normal standard will see dusts in the vicinity of the processing area. But here, in Norvatis, you hardly see any spec of dust.
Materials were taken from store to their production area via a controlled area which they called ASRS. I forgot the actual meaning of this... will check with Norvatis again... But this area form like a staging area between the uncontrolled storage area and the clean processing area.
The materials are sieved and weighed in an area adjacent to this ARSR, but still separated from the processing area. Norvatis practise a policy of no outer packaging of materials inside their processing areas.
Transfer of materials are via enclosed system, by a vacuum transfer mechanism, and weighing was done robotically from one station to another. Manufacturers in Malaysia can forget this system coz we have hundreds of finished products and thousands of materials to weigh! How can such automation be possible....?
In using a computerized robotic system, one really need to trust the computer system in to provide accurate weight of the required materials. It will take me some time too to get comfortable with this system. I believe, the computer validation must be a big task for the people here in Norvatis.
The weighed materials are placed in air tight stainless steel bins and transfer to the processing area (granulator) in the level below. From granulator, a closed system transfer the mixed granules direct to a fluid bed dryer, which is then directly transfer to a bin at the level below (again via closed system). You simply cannot see the materials being processed here...! While this work well with big batches, students will not be able to learn much if put in such a place during their practical training. Yes, this is no place for 'play-play'.....
The filled bins, containing the dried granules are then brought to a station when the are connected directly to the tablet press below. This tablet press are so fast and efficient that it can produce 500K tablets per hr..! Most of us in Malaysia will complete this is 1 - 2 hours!
Tablet checks and de-dustings are all done within the same room and the completed tablets are transferred to another bin, ready for the next step. Tablets that require coating will be transferred to a tablet coater that coats 400kg of tablet per cycle. You just cannot afford to make mistakes here as it will be a costly one. Surprisingly, the rejects from coating process is less than 5% - far less than we do with a small coater of 60kg per cycle.
Well... there are many more good things in Norvatis which simply can't be illustrated by words..... the building finishing, the gown change, big corridors, auto washing, etc...
If you wish to visit this site, just join for a full package in the next Interphex 2010 and book your free plant tour to Norvatis. It is worth your money & time. Or, you can submit application for a suitable position in Norvatis. Just don't let your boss know........
AJ.
But oh my.... the extent of technology and controls put in was simply fabulous and I felt lucky to be able to experience it.
Handling of materials was given great emphasis and Norvatis practise a close system as far as they can. Such plant by a normal standard will see dusts in the vicinity of the processing area. But here, in Norvatis, you hardly see any spec of dust.
Materials were taken from store to their production area via a controlled area which they called ASRS. I forgot the actual meaning of this... will check with Norvatis again... But this area form like a staging area between the uncontrolled storage area and the clean processing area.
The materials are sieved and weighed in an area adjacent to this ARSR, but still separated from the processing area. Norvatis practise a policy of no outer packaging of materials inside their processing areas.
Transfer of materials are via enclosed system, by a vacuum transfer mechanism, and weighing was done robotically from one station to another. Manufacturers in Malaysia can forget this system coz we have hundreds of finished products and thousands of materials to weigh! How can such automation be possible....?
In using a computerized robotic system, one really need to trust the computer system in to provide accurate weight of the required materials. It will take me some time too to get comfortable with this system. I believe, the computer validation must be a big task for the people here in Norvatis.
The weighed materials are placed in air tight stainless steel bins and transfer to the processing area (granulator) in the level below. From granulator, a closed system transfer the mixed granules direct to a fluid bed dryer, which is then directly transfer to a bin at the level below (again via closed system). You simply cannot see the materials being processed here...! While this work well with big batches, students will not be able to learn much if put in such a place during their practical training. Yes, this is no place for 'play-play'.....
The filled bins, containing the dried granules are then brought to a station when the are connected directly to the tablet press below. This tablet press are so fast and efficient that it can produce 500K tablets per hr..! Most of us in Malaysia will complete this is 1 - 2 hours!
Tablet checks and de-dustings are all done within the same room and the completed tablets are transferred to another bin, ready for the next step. Tablets that require coating will be transferred to a tablet coater that coats 400kg of tablet per cycle. You just cannot afford to make mistakes here as it will be a costly one. Surprisingly, the rejects from coating process is less than 5% - far less than we do with a small coater of 60kg per cycle.
Well... there are many more good things in Norvatis which simply can't be illustrated by words..... the building finishing, the gown change, big corridors, auto washing, etc...
If you wish to visit this site, just join for a full package in the next Interphex 2010 and book your free plant tour to Norvatis. It is worth your money & time. Or, you can submit application for a suitable position in Norvatis. Just don't let your boss know........
AJ.
Tuesday, June 2, 2009
Interphex 2009, day 2.
I was too tired yesterday to write on day 1. We had a dinner function that lasted till 7:30pm. Ms Cheng Mei Fen (Xepa Soul) was the only lucky person from Malaysia to win one of the lucky draw on that night.Today’s topics are heavy and very related to the industry. Today is the second day of this conference and I can tell you for sure that it do exhaust your mind. It is so packed with facts and knowledge that it is really tiring for old man like to absorb all of them… Luckily we have the notes to bring back and review…. The time is too short to discuss all the heavy topics.
Zurina from Pharmaniaga gave a very good and comprehensive account on contract manufacturing of Pharmaniaga. Kudos to her. Talk on Validation Hot Topics at track 3 was full such that the organizer has to bring in more chairs for the participant.
Oh yes… who’s here from Malaysia? I saw people from Idama Pharma, Pharmaniaga and Xepa Soul, and Radhacare Sdn Bhd. But where are the rest…? It really is a waste to miss this chance. ISPE has already brought this good conference near to us. So, we should not waste it. Do not wait for your company to sponsor you. The money spent is worth it.
AJ.
Monday, June 1, 2009
Wow! The workshop on Commissioning & Qualification (C&Q) at the Interphex workshop yesterday was really power packed! With the knowledgable Dr. Alice Redmond and experienced Robert Steen and Joe Eades, we were fed with all the current practices of C&Q. Robert even gave clear examples on C&Q of compressed air and water.
It seems that current practices of C&Q adopt the ASTM E2500-07 and ISPE CQ Baseline guide. This makes planning and pre-drafting of requirements and tests required as a priority. Some also adopt guidance from ICH Q8R. Most still stick to the traditional method via the V-model. An interesting point is the increasing use of risk assessment as a tool to pre-analysis and target only the critical issues, and identifying the Critical Process Parameters (CPP) and the Critical Quality Attributes (CQA) to be used in the conduct of C&Q.
As I said, it was fully loaded with facts. The breakout sessions give us opportunity to further understand and grasp the understanding of the concepts delivered.
How I wish we in Malaysia will soon have our own ISPE affiliates and organize such educational programs for the benefits of our own local colleagues in the pharma industry.
[Note: Sh. Fauziah & Samsinar of Idama Pharma is heading this and let’s hope this Malaysia Affiliate will materialize in due time. Please give themk your support.....].
AJ.
It seems that current practices of C&Q adopt the ASTM E2500-07 and ISPE CQ Baseline guide. This makes planning and pre-drafting of requirements and tests required as a priority. Some also adopt guidance from ICH Q8R. Most still stick to the traditional method via the V-model. An interesting point is the increasing use of risk assessment as a tool to pre-analysis and target only the critical issues, and identifying the Critical Process Parameters (CPP) and the Critical Quality Attributes (CQA) to be used in the conduct of C&Q.
As I said, it was fully loaded with facts. The breakout sessions give us opportunity to further understand and grasp the understanding of the concepts delivered.
How I wish we in Malaysia will soon have our own ISPE affiliates and organize such educational programs for the benefits of our own local colleagues in the pharma industry.
[Note: Sh. Fauziah & Samsinar of Idama Pharma is heading this and let’s hope this Malaysia Affiliate will materialize in due time. Please give themk your support.....].
AJ.
Sunday, May 31, 2009
Prelude to Interphex 2009, Singapore
Well..... here I am in Suntec City, Singapore, for the Interphex 2009. The program starts with pre-conference workshop @ 1:30pm, and I'm not missing this 4hrs workshop on Commissioning and Qualification. Issues discussed will be based on the Baseline Guide issued out by ISPE.I leave home 8:45am (today) from Melaka, and arrive here at 11:30am. I sort of expected a 4 hours journey with traffic congestion at the causeway, customs and imigration checks..... but here I am, earlier than expected.
Alhamdullilah (Thank God) that this Interphex is located in Suntec City. Here, it is a huge shopping complex, with lost of shops, restaurants and entertainment. There are few fast foods with 'Halal' status. So, this will keep me busy till 1:30pm. We even got free wireless here.! That's why I can blog now..... Life couldn't be better.
I'll write some more tonite on the workshop. Hope the workshop is as expected and better than previous years.
AJ.
Friday, May 29, 2009
Purified Water generator unit
Let me first declare that I'm not getting any rewards for writing this, but I can't refute TK Lee that he indeed has a good and simple, yet a complete and rugged product to generate a consistently high quality of Purified Water BP/USP.
[Note: TK Lee is the Malaysian agent for Christ products]
See the picture on the right. Yes, it's none others than Christ's Osmotron Pro Unit. I saw this during the Achema 2009. Well... they do have other better models, but just take a look at this one first.
It is neatly arranged, short pipework, yet easy access to critical components making maintenance and monitoring work very easy. Your engineer will love this piece of equipment.
It is designed to include softener as pre-treatment, other than the usual filtrations , RO (reverse osmosis) and an EDI (electro deionization). You are damned sure you can easily get the water conductivity and the low microbial load that you require. Getting conductivity below 1.0 micro-siemen per cm is no big deal for this guy. Do you know that micro-organisms can't stay alive in an EDI, unless they comes from planet Mars. Hehehe..... just pulling your leg on that planet Mars issue, but it is a fact that EDI also kills all micro-organisms. I'll try to write something about this EDI in my future blog so you'll know how exactly it works.
The necessary monitoring instruments are all in place for this Osmotron, and what further amaze me is its ability to stay 'alive'. Yes, it has a system to recirculate the purified water when there is no demand from the points of use. This drastically reduce the risk of microbial proliferation or bio-film formation within the generator unit itself. And this is done automatically.... No worries mate.
Unfortunately, I somehow tends to equate this Osmotron to a Ferrari, in contrast to what I used to have when I worked in a pharma industry. My old unit was more like a Proton Waja...... cheap with basic function, but doesn't 'run' like a Ferrari... and we cannot afford a Ferrari back then. =(
Actual cost of this Osmotron.....? Well, I dare not ask for the price unless the need arise. TK Lee said it's not expensive comparing to what it can do..... It sounds like a familar sales talk, but I do concur with him. Price is relative and subjective. I would prefer a water generator that can guarantee me the water quality I wanted, rather than worrying on a cheap unit.
Yes, someone out there mention qualification....? That's a piece of cake to these guys at Christ. What more with this simple Osmotron unit, their technician won't even sweat!
I won't say more. If you want more info, or know the actual price, just let me know and I'll give you TK Lee's mobile no. He'll be glad to hear from you. Maybe, I will spend more time with him on this matter... soon.
Azman AJ.
GMP for Veterinary medicines
I believe you all know that soon registration of veterinary medicines will take into effective legal control. Without doubt, the manufacture of such products will require GMP certification. That's why now you see many (but not all...) of these manufacturers working hard to get GMP in place for their existing or new facility.However, take note that animal vaccines are not covered. Yes, animal vaccines do not require registration with the DCA, thus its manufacture do not require GMP. See section 2.2 on 'REGISTRATION GUIDELINE OF VETERINARY PRODUCTS (REGOVP), Version 2' as issued by NPCB, dated August 2008. You can get this from the Veterinary section of http://www.bpfk.gov.my/
On second thought, GMP is a noble thing.... it ensure consistent safety, efficacy and quality of your product, right? So, why throw it aside? We should not adopt GMP out of legal obligation, but should better be out of our committment to our professions and ethics.
I'm glad that there are many of these animal vaccine producers, who are indeed professional and ethical enough to consider compliance to GMP as one of the criteria for their new facility. This is good for the company image and reputation, and also improve their chances of penetrating any overseas market, especially the developed countries.
Keep it up!
Thursday, May 28, 2009
New edition of PIC/S GMP Guidance, PE009-8
Note that this guideline is now updated for the following:
- Revision of Chapter 1 (Part I);
- Revision of Annex 1;
- Adoption of Annex 20 (voluntary).
It has been effective from 01-March-2009. So download the latest version from http://www.picscheme.org/publication.php?p=guides
It's free.... don't worry!
- Revision of Chapter 1 (Part I);
- Revision of Annex 1;
- Adoption of Annex 20 (voluntary).
It has been effective from 01-March-2009. So download the latest version from http://www.picscheme.org/publication.php?p=guides
It's free.... don't worry!
Wednesday, May 27, 2009
Impact of 'failed' GMP projects.
Of late, there are few GMP project in our country that were delayed due to inability to fulfill the requirements of GMP, thus not able to obtain the precious GMP license for operation.
I never knew this could affect any of us. The delayed or failed project seems to adveresly affect those new in the field of pharma manufacturing.....
Last week, I was shocked when I was informed that my client's application for loan was stucked. The bank has imposed a new condition of 'obtaining a GMP license' before my client's loan can be approved..!
This is simply ridiculous. It's just like requesting a developer to show the certificate of fitness for the building before the loan can be approved.....
So, I went with my client today to meet up with the bank officer and try convince them that their condition is impossible to meet. If we have the GMP license, we will already be in operation and do not need their money anymore!
So, explain I did, in all aspects of GMP, insisting that we have obtained approval for the design layout and put all perspective in place, right up to personnel. But it was in vain.
Since the bank has bad experiences with most of their pharma clients, where there were delayed in obtaining GMP license (and the bank claim that as a failure.... due to late re-payment!), the bank management now wants a 'guarantee' from someone reliable & capable to assure and guarantee the success of this project.!
By right the guarantee should be the CEO or board of directors (BoD), but this is not to the bank preferences.... they wanted someone like the Architect, engineer, consultant or project manager to give the guarantee. No one from these group of people can give such extreme guarantee...
It seems that they will accept guarantee from the CEO if I'm the CEO. So guys, don't be surprised if I informed you I'm a CEO in my next blog..... hehe... mimpi lah!
It is easy for the bank to demand for a GMP license, when in actual fact it is actually impossible to the borrower. Who in the right mind will want to give a guarantee of success when there many variable factors for the success...?
There are issues of building, facility and utilities, and their qualifications.... there are issues of equipment and its qualifications.... there are issues of systems, processes and documentation.... there are issue of personnel adequancy and competency..... we have process validations...... issues of maintenance.... and many others. So, the success (ability to get GMP license) all lies in meeting all these variables. We always PLAN FOR SUCCESS, BUT WE CAN NEVER GUARANTEE SUCCESS (unless you are God!).
So, who else can consolidate and ensure these variables are all met other then the CEO or BoD..? (be they knowledgable or not in GMP), right?
It seems my client now face a solid wall to their project. I don't know yet what we will do, but once we are able to unravel this pecualiar situation, you guys will be the first to know.
So, keep posted.....
I never knew this could affect any of us. The delayed or failed project seems to adveresly affect those new in the field of pharma manufacturing.....
Last week, I was shocked when I was informed that my client's application for loan was stucked. The bank has imposed a new condition of 'obtaining a GMP license' before my client's loan can be approved..!
This is simply ridiculous. It's just like requesting a developer to show the certificate of fitness for the building before the loan can be approved.....
So, I went with my client today to meet up with the bank officer and try convince them that their condition is impossible to meet. If we have the GMP license, we will already be in operation and do not need their money anymore!
So, explain I did, in all aspects of GMP, insisting that we have obtained approval for the design layout and put all perspective in place, right up to personnel. But it was in vain.
Since the bank has bad experiences with most of their pharma clients, where there were delayed in obtaining GMP license (and the bank claim that as a failure.... due to late re-payment!), the bank management now wants a 'guarantee' from someone reliable & capable to assure and guarantee the success of this project.!
By right the guarantee should be the CEO or board of directors (BoD), but this is not to the bank preferences.... they wanted someone like the Architect, engineer, consultant or project manager to give the guarantee. No one from these group of people can give such extreme guarantee...
It seems that they will accept guarantee from the CEO if I'm the CEO. So guys, don't be surprised if I informed you I'm a CEO in my next blog..... hehe... mimpi lah!
It is easy for the bank to demand for a GMP license, when in actual fact it is actually impossible to the borrower. Who in the right mind will want to give a guarantee of success when there many variable factors for the success...?
There are issues of building, facility and utilities, and their qualifications.... there are issues of equipment and its qualifications.... there are issues of systems, processes and documentation.... there are issue of personnel adequancy and competency..... we have process validations...... issues of maintenance.... and many others. So, the success (ability to get GMP license) all lies in meeting all these variables. We always PLAN FOR SUCCESS, BUT WE CAN NEVER GUARANTEE SUCCESS (unless you are God!).
So, who else can consolidate and ensure these variables are all met other then the CEO or BoD..? (be they knowledgable or not in GMP), right?
It seems my client now face a solid wall to their project. I don't know yet what we will do, but once we are able to unravel this pecualiar situation, you guys will be the first to know.
So, keep posted.....
Adios to Students from Kulliyah Pharmacy, IIUM !
Thanks Bros & Sisters...!
You made me feel appreciated by linking my blog to yours. I promised you that I'll be more aggresive and more frequent in my discussions of cGMP matters.
If you have any issues to be raised, feel free to let me know. It's good to share knowledge. Like my mentor used to say, "Knowledge shared is knowledge gained!"
You made me feel appreciated by linking my blog to yours. I promised you that I'll be more aggresive and more frequent in my discussions of cGMP matters.
If you have any issues to be raised, feel free to let me know. It's good to share knowledge. Like my mentor used to say, "Knowledge shared is knowledge gained!"
Saturday, May 23, 2009
Stainless steel or PVC pipes in water system?
It is the norms that for pharma water system, we require SS316L, internally polished to less than Ra 0.8 micron, for piping from the purification stage to storage tank of purified water and to the distribution loop. Some may go beyond this to have the same pipe quality for piping in betwen the RO system. While this is acceptable for RO system, we cannot assume the same to be for a DI system, especially a twin bed resin system.
Why not?The simple reason is due to the requirement for self-regeneration for a DI system. Acid, such as hydrochloric acid, and alkali, such as sodium hydroxide, will be used to regenerate the resins. As we know, acids & alkalis are simply corrosive to SS pipes. This serve to place high risk to the purification system itself and to the quality of the output water .
So, be conservative and stick to the usual cheap PVC pipe for connection in between the DI unit. Don't simply overdo and put your own water system at risk.
Monday, May 18, 2009
To have own plant or contract manufacture?
I just met a potential client who has only one product and desire to build a GMP Plant. He's dammed surprise to hear the cost and hardship that will face him. Then, why can't he just contract manufacture...?Always this is the dilema faced by a product licensed holder who is new in this field. Constructing a GMP plant is not as simple and cheap as a 'normal' processing plant, say for a food industry. The construction materials used, the finishing, utilies, equipment and system controls will not make it easy for you.
So, unless you do have solid grounds on having your own GMP plant, or have adequate sales volume, then only having your own GMP plant will make sense.
If not, go for contract manufacturing dear..... there are many GMP manufacturers out there who are eagerly waiting for this job, some to make up for their unused capacity they possessed and others to cover their operational expenses!
If not, go for contract manufacturing dear..... there are many GMP manufacturers out there who are eagerly waiting for this job, some to make up for their unused capacity they possessed and others to cover their operational expenses!
A smart businessman will start with having his products established first in the market, get the sales volume to build up, by just contract manufacturing all his products. He will have no headache on the plant investment, maintenance and operation - just concentrate on marketing and sales! How good can that be...
But on the bad side, my client told me that his formula can be copied. Yes.... that's partly true if the contract manufacturer has low ethics value and professionalism. However, why worry....? someone can have the same product from other source too. You can now have well known brand being copied easily, which I think is far worse than having someone 'copied' your formula and with a different name.
The previous company I worked in had their saleable product copied by someone. Almost all aspects of the product are the same, except for the product name. But yet, the product can't sell as well as the 'original' product. The aggressive marketing strategy makes this product hold well in the market.
So, my advice to those 'small volume' product owners, do away with having your own GMP plant for now. Look for a good cintract manufacture, wirk with them and make your money first. Once you have enough sales figure, then do come to me on how you can set up your own GMP plant.!
Adios!
Thursday, May 14, 2009
Achema 2009
Finally I arrived at Achema 2009. Venue Frankfurt, Germany. It really is a good show with so many exhibitors around. There are 8 exhibition halls, with some halls more 3 levels. And believe me, you will need all the 4 days to finish all.
I have only 2 days and spend my time more on the pharma processing & packaging equipment, and water system. There were IMA, Korsch, Bosch, Bausch & Strouble, Romelag, Wilco, Quadro, Ludige, MG-2, Glatt, GEA, and many more..... some never heard of before. I simply couldn't find time to cover all. Maybe this will be a good reason to go again for Achema 2012!
I don't see many Malaysian, except 3 equipment suppliers. I may have missed them amongst all the crowd. Just too many people around you......
There are many new technology on display. But don't ask for the price. All in euros lah...!
We can ask many questions to their experts and get satisfactory answers. Food are abundant. I don't even have to spend any euros to have my stomach filled and my thirst quenched.
Only problem is the heavy load to carry - with the many brochures given away.....
Make it a point to come to Achema, at least once in your lifetime. This is one experience you will treasure forever.
Sunday, May 10, 2009
On the road to Achema - Part 2
Well..... what can I say....?Here I am in London, posing in front of the famous Buckingham Palace. Too bad the Queen was not there to greet me....
Tour in London is easy with their city day tour package, which includes boat cruise along the Thames River. Cost me £24. Sounds cheap, but convert to RM... Cheap now?
Behind me is the Big Ben and House of Parliament, where the Ministers are now defending allegations that they have misuse public funds by making un-reasonable claims!
Other than the rebate of £2000 offered for scrapping a 10 year old car, this allegation is the hot political topic now in London.
I got off from the boat cruise at Tower bridge and took this photo. Some of you may think this is the London Bridge - actually London Bridge is not this. This is the Tower Bridge. !
The song 'London Bridge is falling down refers to the bridge 'collapsing', not the bridge center closing after making way for big ships to pass through..
Sorry, some info there that is totally non-GMP....
Saturday, May 9, 2009
The road to Achema
Phewh.... The FAT in Germany and the waiting to Achema gives us (me & Kausar) a chance to travel Euro! We took train to Amsterdam, stay one night and have a good tour of the famous city.
The canal cruise was simply great.Eat your hearts out....!
Next trip to London.Will keep you all posted once I've settled down and organize myself.
Picture on left show me getting on the Euro train to London, via the English Channel tunnel.
Friday, May 8, 2009
Blog from editors of Pharmaceutical Technology
This is a very resourceful and interesting blog for those involved in the field of pharmaceutical industry. Go to http://blog.pharmtech.com/ You will be able to read blogs from various editors of the Pharmaceutical Technology journal.Thursday, May 7, 2009
How to get more info on GMP ?
Where can we get our supply of knowledge on GMP practises? For this question, I strongly suggest you subscribe to ISPE and PDA.
ISPE is International Society for Pharmaceutical Engineering. It cost only USD 40 for an annual fee to members feom 'emerging economic contries' like Malaysia. I paid jst that. Log on to http://www.ispe.org/ for more info. Being member, you get to access their website containing full of useful and up-to-date info on cGMP practises. ISPE also organize numerous GMP trainings, usually overseas. A conference will be held in Singapore soon, from 31 May to 2 June. Scroll down my blog for more info on this conference.
PDA is Parenteral Drug Association. Log on to website http://www.pda.org/ for more info. This association deals with hard stuff in GMP, especially on sterile pharmaceuticals and bio-pharmaceuticals. Membership fee is USD 249, but it only cost USD100 for members from economic developing countries (as classified by the World Bank). I'm not sure about this as I paid the full USD 249....
Members get regular newsletters containing news, discussion and short articles, and journals on various studies done - all related to pharma industrial practises. Many good books are also produced by PDA dan numerous good trainings and conferences are held regularly, all over the world.
Just being members to these two organization will keep you busy keeping up with the vast info presented. I know, coz I find it tough to finish reading all the newsletters, journals and articles provided by them.
These 2 subscriptions are really worth your money spent. Trust me!
Wednesday, May 6, 2009
FAT for Diosna High Speed Mixer.
Germans are really good. I'm having fun doing FAT for this high speed mixer-granulator. Capacity is small but well equipped with controls and safety features.All controls via PLC touch screen control panel.
Mixer and chopper speed are adjustable and we also have temperature probe to monitor the product temperature.
The best thing is this machine comes with a wash-in-place (WIP).
Simply wonderful!
Is change a good thing in GMP?
Change for the better is always good, not only in GMP, but in any other matters. However, in GMP, you cannot simply change as you wished. GMP is about maintaining order and ensuring consistency in meeting the quality parameters of products. So, while some changes are genuinely good, we are not allowed to assume it as such in a GMP environment.
There are many instances whereby a manufacturer had a good start, having all utilities, equipment and processes qualified and validated. But after a period of time, product defects start to creep up and bad incidents grow in numbers. I bet you all these are mainly due to changes done by some smart guy, without proper control and approval.
As a rule of thumb, always assume change as something that is not wanted, or presenting risk to product quality. Resist change. Be on the offensive to any proposal for change. It may sound like you are a person with a 'closed mindset', but this all need to be done to safeguard the interest of GMP.
Any change proposed, be it from the from the lowest rank personnel in the organization, or from the top person (CEO), must undergo systematic scrutiny and levels of approval. This is more crucial for validated processes whereby efforts have been taken, painstakingly, to prove that the process is capable, effective, reliable and robust.
Look at the proposal for change, critically scrutinize and seek for justification before accepting it. Get the 'subject matter expert' to approve and the QA Manager to authorize the change. Plan what need to be done to get the change executed and outline procedures to ensure that the change do not affect the final quality of the product. If necessary, re-qualify (for equipment and utilites), or re-validate (for processes). NEVER TAKE CHANGE AS A MINOR ISSUE!
Most importantly, record all the actions and decisions that took place.
The change management itself must have authorized written procedure to ensure reliability and consistency in handling of changes to any part of the operation.
Any changes in the ' Change Procedure' must also undergo the same procedure before the change handling procedure is effective.
Sounds a little winding, but think carefully..... it does make sense!
There are many instances whereby a manufacturer had a good start, having all utilities, equipment and processes qualified and validated. But after a period of time, product defects start to creep up and bad incidents grow in numbers. I bet you all these are mainly due to changes done by some smart guy, without proper control and approval.
As a rule of thumb, always assume change as something that is not wanted, or presenting risk to product quality. Resist change. Be on the offensive to any proposal for change. It may sound like you are a person with a 'closed mindset', but this all need to be done to safeguard the interest of GMP.
Any change proposed, be it from the from the lowest rank personnel in the organization, or from the top person (CEO), must undergo systematic scrutiny and levels of approval. This is more crucial for validated processes whereby efforts have been taken, painstakingly, to prove that the process is capable, effective, reliable and robust.
Look at the proposal for change, critically scrutinize and seek for justification before accepting it. Get the 'subject matter expert' to approve and the QA Manager to authorize the change. Plan what need to be done to get the change executed and outline procedures to ensure that the change do not affect the final quality of the product. If necessary, re-qualify (for equipment and utilites), or re-validate (for processes). NEVER TAKE CHANGE AS A MINOR ISSUE!
Most importantly, record all the actions and decisions that took place.
The change management itself must have authorized written procedure to ensure reliability and consistency in handling of changes to any part of the operation.
Any changes in the ' Change Procedure' must also undergo the same procedure before the change handling procedure is effective.
Sounds a little winding, but think carefully..... it does make sense!
Welcome to my followers!
Thanks Dr Kausar and Bro Ilham for being my followers. I will return your good favor with many in-sights on GMP matters - very detailed issues frequently ignored or taken lightly by "GMP practitioners".
I welcome any comments and inputs from you any anyone else who read my blog.
Rgds,
I welcome any comments and inputs from you any anyone else who read my blog.
Rgds,
Osnabrück, Germany
Here I am.... in Osnabrück, Germany, along the Krahn Strausse. What am I doing here? Well, tomorrow me and Dr Kausar will perform Factory Acceptance Test (FAT) on the high speed mixer-granulator that IIUM bought from Diosna. Arriving early today, we decided to explore this town ourselves. Tomorrow we work!
Monday, April 27, 2009
IIUM Pilot Plant near completion
Just came back from Kuantan today after visiting IIUM Pilot Plant. Looks like its almost 'ready' for all equipment to come in.Key personnel has been interviewed and those suitable should be given the appointment letter soon. Congrats to those selected! These are indeed capable people who will serve the Pilot Plant and Kulliyah Phamacy well. How I wish I'm young enough to be part of this Pilot Plant -as a permanent staff.
However, water system has yet to be installed and pipe work yet to be completed. I guess the water room is not ready for the contractor to bring in their equipment. Where are the promises...???Internal rooms need to clean up. It's still a mess with leakages from dunno where... Believe me, the microbes there should be the happiest creatures around..!
Internal staircase yet to be completed. Speakers are seen dangling from ceiling. Fire door yet to be painted and utilities opening in panel yet to cover up. And where are the furnitures and sinks...? Must be same security issue with the water system - no security, furnitures cannot come in for fear of it being taken away by someone who loves staineless steel for their home.
I do hope the main contractor will do their best to put things back in order. Buck up guys!
For all the equipment supliers out there, be ready to install and commission all your equipment after 18 May 2009. Hope by then, all key personnel will be there to supervise and witness the installation & qualification....... Isya-Allah!
Sunday, April 26, 2009
The weak link.
It worry me to realise that many of our Malaysian manufacturers choose to ignore the risk we faced when many of their operation personnel are inadequately trained. The percentage is higher amongst the cosmetics and traditional/herbal product manufacturer, as compared to the pharma. Yes, most of us acknowledge the importance trainings play to ensure compliance to set procedures and GMP requirements. GMP auditors too always look into this matter during their surveillance audits. But how many actually put in concerted effort for a proper training need analysis, and plan their training program...?
'No problem' one might say, and add, 'Just send to any one of the GMP training program available'.
But then, how many personnel can the company afford to sent to such trainings? Mind you, most of these trainings are expensive....... How often such training are available? And are these training tailored to meet the participants' organization needs?
While external trainings are considered useful to accquire new knowledge and achieving a higher level of competency, I find internal trainings as the most dependable tool to ensure that ALL operation personnel are adequately trainned to execute their job functions and to understand (and thus comply) to the numerous GMP rules and requirements.
Get a subject matter expert (SME) in the organization to 'teach' subjects best know to them. If such SME are not available, do not fear to fork out a small sum of money to engage external SMEs for conduct on your internal trainings. Get your calculator and calculate the cost you incur by calling an external SME to train your few groups of personnel. Add the saving you obtained from your personnel travelling and accomodation (as required for external training), you'll easily concur with me the substantial savings you 'accquire'. What about the benefits you get when such trainings are specifically tuned to meet your current needs...? You can't value that.!So dear fellow friends..... plug that weak link in your operation. Do something to improve GMP compliance. Conduct internal trainings.!
Saturday, April 25, 2009
Water system: DI or RO?
This issue seems to trouble many new starters in GMP. Should the water purification be deionization (DI), or via reverse osmosis (RO)?The answer actually lies on the final output desired. The output quality must be able to achieve the desired specification for a Purified Water, usually in compliance to BP or USP. So, you can use either DI, or RO, or combination of both, as long as the final output meet the pre-determined specification.
The difficult and expensive portion is to ensure that the water purification design is able to consistently produced water of the desired specification. There should be a pre-treatment water treatment system, before the actual purification stage. Contact materials used after the purification stage, should be inert and not promote microbial growith, and there should be no dead legs that allow 'obstructive' flow within the water system.
Put your trust in the expert to design the best water system, that falls within your budget. Do not take risk by designing your own system if you do not have the experience and knowledge in this subject.
Finally, always qualify your water system before using it.
Interphex 2009 in Singapore
Date: 31 May to 02 June 2009.Don't miss this opportunity to get yourself updated with the latest trend and practises in pharma industry. You get to hear from the experts, make contacts, and what I like most, is the chance to visit a well established pharma plant. You won't be able to walk into them unless you have good reasons!
There are few exhibitors, but not comparable to Achema..! But it'll do you good as you need to spend more time in the conference.
Check the details from http://www.interphexasia.com/en/ispe-singapore-conference/
Trust me, you'l really enjoy this conference.
Achema
ACHEMA 2009 is just round the corner. Frankfurt , Germany has been the main venue for this exhibition. I can say that this is the biggest exhibition of pharmaceutical machineries with the latest technologies being promoted to visitors. Other related materials are also exhibited. Glad that I'll be there from 11 to 14 May 2009.
I have a FAT to conduct on behalf of IIUM, for a High Speed granulator, purchased from Diosna. Since all fares are paid for, I might just as well extend my stay in Germany to attend this glamorous Achema...!
Meet me there! Will keep you posted after my trip.
For details on Achema, go to http://www.achema.net/
FAT in Shanghai, China
GMP requires new equipment be pre-inspected before delivery to processing site. This gives us opportunity to verfiy that the Design Specifications comply to our User Requirement Specifications (URS) and also an opportunity to travel!
Picture on right is us at Yang Garden.
This FAT is for a tablet coater in Shanghai, China.
Picture on right is us at Yang Garden.
We then moved on to Shanghai river bank and admire the cherry blossoms. Never hold one in my life.......
And that's us by the river.
As the saying goes.... 'All work and no play makes Jack a dull boy'.
So, we work, then 'play'..... hehe....
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