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.

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.

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.

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.

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.

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.

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.