Friday, May 29, 2009

GMP for Veterinary medicines

I believe you all know that soon registration of veterinary medicines will take into effective legal control. Without doubt, the manufacture of such products will require GMP certification. That's why now you see many (but not all...) of these manufacturers working hard to get GMP in place for their existing or new facility.

However, take note that animal vaccines are not covered. Yes, animal vaccines do not require registration with the DCA, thus its manufacture do not require GMP. See section 2.2 on 'REGISTRATION GUIDELINE OF VETERINARY PRODUCTS (REGOVP), Version 2' as issued by NPCB, dated August 2008. You can get this from the Veterinary section of http://www.bpfk.gov.my/
On second thought, GMP is a noble thing.... it ensure consistent safety, efficacy and quality of your product, right? So, why throw it aside? We should not adopt GMP out of legal obligation, but should better be out of our committment to our professions and ethics.
I'm glad that there are many of these animal vaccine producers, who are indeed professional and ethical enough to consider compliance to GMP as one of the criteria for their new facility. This is good for the company image and reputation, and also improve their chances of penetrating any overseas market, especially the developed countries.

Keep it up!

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