Doing work as a consultant brings me to see many facilities. I am amazed with the high numbers of licensed manufacturers being unaware of the needs to conduct stability studies for all registered products; be it theirs or products owned by others (contract givers).
It is prudent to note that the responsibility is on the product licensed holder to conduct a Real Time stability study as per the ASEAN Stability study guideline, once the product is registered and manufactured. Your product may be withdrawn if this is not done.
To conduct stability study, you just need to take 3 different batches of each product. It further amazed me when manufacturers took the pain to keep samples from EVERY batches produced for the stability study..! No wonder some people are so tied down with work that they are unable to see what exactly are required for the stability study.
The storage condition is another common blunder where you can see stability samples kept in a conditoned different from the recommended storage condition as stated on label. Such act will simply invalidate all the effort done in your stability studies.
My suggestion...... please find some time to read up the guideline and plan for your stability study program. The time spent is worth the effort taken.
AJ.
Friday, April 9, 2010
Friday, March 26, 2010
To Pilot Plant IIUM
Bravo! Finally we see some light to the end of the tunnel for this Pilot Plant. It is usual to have glitches here and there, but as long as the management understand and cooperates (in terms of financial assistance), I am sure all problems can be solved....
The waiting still prevails. We still have some minor loose ends with the utilities qualification. Few more equipments are pending qualification.
But we do have the human resources to get the plant busy.... So girls and boys, carry on with your routine operation run. Get familar with all the utilities operation and controls. Run the machines and be familiarize with the settings. Also finally..... clean, clean, and clean.....! Keep the plant sparkling clean and shine...!
Since GMP relys on documentation and records, do get all the SOPs ready for use on the shop floor. Whatever done, make sure it is recorded.
Let's make this pilot plant ready at any time for the pre-licensing audit.
AJ.
The waiting still prevails. We still have some minor loose ends with the utilities qualification. Few more equipments are pending qualification.
But we do have the human resources to get the plant busy.... So girls and boys, carry on with your routine operation run. Get familar with all the utilities operation and controls. Run the machines and be familiarize with the settings. Also finally..... clean, clean, and clean.....! Keep the plant sparkling clean and shine...!
Since GMP relys on documentation and records, do get all the SOPs ready for use on the shop floor. Whatever done, make sure it is recorded.
Let's make this pilot plant ready at any time for the pre-licensing audit.
AJ.
Wednesday, March 24, 2010
GMP dilema
GMP guidance provides ample guides in ensuring the safety and quality of drugs manufactured. As the name implies, it serves only as a guide, not as a rule that you MUST follow.
This leaves us a lot of freedom to implement methods most suitable to our own needs, and methods better than what is practised by others. More often, you will always need to support your unique ways of doing things to satisfy the auditors - leaving most of us going for the safe approach and instead 'follow what others are doing.' Thus, lacking in creativity.
Another 'problem' of the GMP guidance is its non-specificity. For example, does a buffer room require an interlocking system? Why can't you release your products direct into a Quarantine room; from here it is released directly to the approve store? Must you need a buffer room for finished goods before going into a quarantine room? Is it compulsory to have a quarantine dedicated area, or can we use flexible methods to identify quarantine items, such as by ropes and quarantine labels.?
There are many more issues pertaining to GMP guidance. I hope I can have some comments or share of experience from you all out there....
This leaves us a lot of freedom to implement methods most suitable to our own needs, and methods better than what is practised by others. More often, you will always need to support your unique ways of doing things to satisfy the auditors - leaving most of us going for the safe approach and instead 'follow what others are doing.' Thus, lacking in creativity.
Another 'problem' of the GMP guidance is its non-specificity. For example, does a buffer room require an interlocking system? Why can't you release your products direct into a Quarantine room; from here it is released directly to the approve store? Must you need a buffer room for finished goods before going into a quarantine room? Is it compulsory to have a quarantine dedicated area, or can we use flexible methods to identify quarantine items, such as by ropes and quarantine labels.?
There are many more issues pertaining to GMP guidance. I hope I can have some comments or share of experience from you all out there....
Saturday, March 6, 2010
GMP Training
We in Malaysia are not short of GMP trainings. MOPI and NPCB play active roles in providing and organizing relevant GMP trainings for the industries.
However, some of us may feel that the fees imposed are on the high end. Average charges is RM2,000 per person for a 2 days program, inclusive of training materials and refreshments. This is not inclusive of travelling and accomodations.....
[ Note: NPCB own training program are much cheaper, rarely exceeding RM500 per person for a 2 days program.]
Although we feel that this is expensive, it is relatively cheaper than the rates in Singapore. There are much more GMP training programs there and all are well attended by locals and foreigners.
Why expensive? This is purely to the fact that such training programs are highly specific and conducted by experienced people. You have to pay to get such knowledge and experience....
An alternative is to conduct an in-house training program. This is value for money as you'll be able to transmit the knowledge to more of your personnel. Check your target group.... if you need to train only your new executive, supevisors and below, why spend so much for a foreign trainer? You can easily get a local GMP trainer for such needs. The rates are cheaper, and the plus point; you can also claim 50% from the HRDF for such training program.
So, consider this point when you plan for your personnel training next time.
AJ.
However, some of us may feel that the fees imposed are on the high end. Average charges is RM2,000 per person for a 2 days program, inclusive of training materials and refreshments. This is not inclusive of travelling and accomodations.....
[ Note: NPCB own training program are much cheaper, rarely exceeding RM500 per person for a 2 days program.]
Although we feel that this is expensive, it is relatively cheaper than the rates in Singapore. There are much more GMP training programs there and all are well attended by locals and foreigners.
Why expensive? This is purely to the fact that such training programs are highly specific and conducted by experienced people. You have to pay to get such knowledge and experience....
An alternative is to conduct an in-house training program. This is value for money as you'll be able to transmit the knowledge to more of your personnel. Check your target group.... if you need to train only your new executive, supevisors and below, why spend so much for a foreign trainer? You can easily get a local GMP trainer for such needs. The rates are cheaper, and the plus point; you can also claim 50% from the HRDF for such training program.
So, consider this point when you plan for your personnel training next time.
AJ.
Saturday, February 20, 2010
Murphy's law
I always remind my client to abide by Murphy's law. Things can go wrong and it will always go wrong at the wrong time.
Many pharma manufacturers have been caught with this situation but only a few learnt their lesson well.
There are still many manufacturers who choose to give more priority to meeting sales demand rather than keeping an eye on their GMP state of compliance. When we get too comfortable, we tends to overlook the common mistakes and non-compliances, to the extent that it becomes 'normal'.
It will take few rounds of audits by the GMP auditors before the bad state of non-compliance get noticed and warrants a suspension of the manufacturing operation. Only when this occurred, the alarm bell will immediately be sounded in each of the management's head and trigger finger pointings. But alas.... this is too late. Damage is done.!
So, what's left next is 'damage control'. With the operation suspended, the affected manufacturers will now have ample time and space to rectifying all their problems and hopefully get back their manufacturing license within the shortest time possible.
But wouldn't it be good if efforts are taken before the suspension is imposed...??
AJ.
Many pharma manufacturers have been caught with this situation but only a few learnt their lesson well.
There are still many manufacturers who choose to give more priority to meeting sales demand rather than keeping an eye on their GMP state of compliance. When we get too comfortable, we tends to overlook the common mistakes and non-compliances, to the extent that it becomes 'normal'.
It will take few rounds of audits by the GMP auditors before the bad state of non-compliance get noticed and warrants a suspension of the manufacturing operation. Only when this occurred, the alarm bell will immediately be sounded in each of the management's head and trigger finger pointings. But alas.... this is too late. Damage is done.!
So, what's left next is 'damage control'. With the operation suspended, the affected manufacturers will now have ample time and space to rectifying all their problems and hopefully get back their manufacturing license within the shortest time possible.
But wouldn't it be good if efforts are taken before the suspension is imposed...??
AJ.
Monday, December 7, 2009
Process vallidation
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.
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.
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.
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