Do anyone come across any guides for Veterinary medicinal products premises and requirement (for solid, oral and sterile product)? In Pic’s, only small portion in one of the annex (annex 4), do not have much info in this guide;
What facility grade is necessary for oral and liquid veterinary plant, is it need Grade D condition?
For terminal sterile product, what is the requirement in grade?
As well as Aseptic filling machine (the product will be sterile filtered before filling), what is the requirement in grade?
Well, animal usage medicinal product is not so critical compared with human used drug, afraid over-design on the specification and will put us more burden and the manufacturing cost will shoot high;
Hope someone can help;
How about water quality? also need to use Purified water or WFI?
The MHRA takes the view that medicinal products for use in animals are subject to the same, yet separate, legislation as humans. Therefore your approach to animals should be the same approach you would use for human products with regards to all your grading questions on facilities, systems and quality water plants etc.
In other words, there should be no difference in the level of “Validation” between human and animal product manufacturing facilities and systems, and they still have to have all of the licenses to get the GMP certification to manufacture and market their medicinal products for animals.
The separate legislation tends to be driven by the Veterinary Medicines Directorate (VMD).
The EU directive for the manufacture of animal products, with respect to GMP requirements of facilities and systems in animals, is Commission Directive 91/412/EEC.