Vet, oh vet.........

Now that the dateline for registration of veterinary medicines is over, I can divert my focus to my routine jobs. Things were abnormal during submission of the vet medicines before the dreaded due date.

Now need to focus on the plant design and construction of vet medicinal manufacturers. Got a small handful of jobs on this, but enough to keep me busy and survive....

Although the standards to be followed by vet manufacturer is still the same PIC/S GMP guidance, Annex 4 of the guidance allows some leniency in the facility design. For instance, vet manufacturers are allowed to manufacture beta-lactam products in the same facility as other products, provided it is done on a campaign basis and efforts taken to ensure effective removal of any beta-lactam residues before the change over to another product.
Annex 4 also allows manufacture of sterile products be done in a lower grade than human sterile medicines, but not lower than Grade D. Well...... that's fair enough.

However, I am still amazed with the requirements to fully comply with the pharma standards for water system....... Yes, we may comply to this, but just give a second thought on what the animals eat or drink after consuming these 'high standard' medicines...? Yes, they go back to the usual hay, or feed, etc, all from the usual receptacles, and may drink from a trough, river or pond.... That sure has much higher level of impurities and microbes!

Just give that second thought.....

AJ.