GMP for Veterinary Medicinal Manufacturers

Time flies, and it's now almost to the dateline for registration of verterinary medicines. The last date is 30 June 2009, which is less than one month away.
As part of registration requirements, local manufacture need to produce at least a Letter of GMP Compliance, although some say that a letter of submission for plant GMP layout will suffice.

The pertinent issue of concern to many is the needs for GMP compliance for manufacturing sites, producing veterinary medicines. While few have obediently initiated work to set up a GMP compliant facility, many still adopt the 'wait-and-see' stance. I don't know what are these people waiting for..... GMP is there to stay and be implemented as per schedule.

Yes, the needs to comply to GMP will incur high investment cost. This will undoubtly hinders the noble effort by our Ministry of Health (MoH) to ensure GMP compliance to all manufacturers. However, I feel the MoH should also lent an ear to these group of people. Cost is always a problem and it is easier said than done that these manufacturers must put in all effort in obtaining GMP compliance, or have their products withdrawn from the market.

I remember when we started GMP for the human medicinal products, way back in year 1987. Ample time were given to introduce GMP and more time given for the players to upgrade from a lower level to the high level of GMP that we have adopted now.
I hope the same can be accorded to these vet medicinal manufacturers.

It's good that validation is not compulsory, but the authority seems to require some form of 'verification'. And at to what level this 'verification' is needed was not clearly stated.
Another issue is the water requirement. Imposing that the water must comply to BP and USP can be an extremely expensive affair. Why not follow the same specs for manufacturers of herbal and traditional medicines? Give them say 3 - 5 years and impose these requirements later, when they have settled down with the infrastructure and operation system.
Other issues will be like material sampling and evaluation, in-process controls, environmental air quality, and stability studies. These are critical issues, but just allow them to focus on the basic issues like facility, personnel and documentaion as a start.

I understand the needs for a high quality products to ensure safety to human, especially for drugs used on animals that will be consumed by humans. But it also can be 'contradicting' when one realize that these animals will also consume their food from ground, some eat grass from the fields and most drinks from lakes, streams and drains....

Give a tinker on the above and extend some mercy to these vet medicinal manufacturers, at least for these few years.....

AJ.