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.