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.
Friday, March 26, 2010
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.
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