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.
Monday, June 29, 2009
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.
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