ABSTRACT
The pharmaceutical industry of the European Union maintains high standards of quality assurance in the development, manufacture, and control of medicinal products. Detailed guidelines in accordance with those principles are published in the Guide to Good Manufacturing Practice (GMP), which will be used in assessing applications for manufacturing authorizations and as a basis for inspection of manufacturers of medicinal products. All member states and the industry agreed that the 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 annexes specific to veterinary medicinal products and to immunologic veterinary medicinal products. The manufacture of medicinal products has for many years taken place in accordance with guidelines for GMP and the manufacture of medicinal products is not governed by CEN/ISO standards.
