Monday, December 7, 2009
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...!
Saturday, October 17, 2009
Thursday, October 15, 2009
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: email@example.com), or Mdm Juliana at 09-5716400 ext 268 (email: firstname.lastname@example.org). You can also contact me....!
There's only 10 places for the first year. I guess it will be first come first serve basis.
Saturday, October 10, 2009
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.
Wednesday, October 7, 2009
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!
Thursday, September 10, 2009
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....?
Sunday, September 6, 2009
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...?
Friday, August 21, 2009
This is Kotra Pharma's existing plant. Already a big one.....
Now you only see 50% of the building
Monday, August 17, 2009
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.
Saturday, August 8, 2009
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.
Saturday, July 25, 2009
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.
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!
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..!
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...!
Sunday, July 12, 2009
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.
Sunday, July 5, 2009
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.....
Monday, June 29, 2009
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.
Thursday, June 25, 2009
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
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.
Sunday, June 7, 2009
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.....
Thursday, June 4, 2009
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........
Tuesday, June 2, 2009
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.
Monday, June 1, 2009
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.....].
Sunday, May 31, 2009
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.
Friday, May 29, 2009
Keep it up!
Thursday, May 28, 2009
- 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
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.....
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
Monday, May 18, 2009
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!
Thursday, May 14, 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
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
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.
Friday, May 8, 2009
Thursday, May 7, 2009
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.
Wednesday, May 6, 2009
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).
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!
I welcome any comments and inputs from you any anyone else who read my blog.
Monday, April 27, 2009
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..!