ABSTRACT
The manufacture of medicinal products has for many years taken place in accordance with guidelines for Good Manufacturing Practice (GMP), and the manufacture of medicinal products is not governed by European Committee for Standardization/International Organization for Standardization standards. All member states and the industry agreed that the GMP requirements applicable to the manufacture of veterinary medicinal products are the same as those applicable to the manufacture of medicinal products for human use. Certain detailed adjustments to the GMP guidelines are set out in two annexes specific to veterinary medicinal products and to immunological veterinary medicinal products. The former Annex 18 has been replaced by the new Part II of the GMP guide, which has an extended application for both the human and the veterinary sector. GMP is concerned with both production and Quality Control. Quality Control is not confined to laboratory operations but must be involved in all decisions that may concern the quality of the product.
