Guidelines of Good Manufacture Practice (GMP)for Veterinary Drugs Manufacturers Article 3

The terms prescribed in the Guidelines are defined as follows:1. Drug: denotes the veterinary drugs prescribed in Article 3 of the Veterinary Drugs Control Act;2. Raw material: denotes any substance used in the manufacture processof products, including those not included in the final product;3. In process material or intermediate product: denotes any product obtained during the manufacture process able to become the product via the post manufacture process;4. Product: denotes that after manufacture process, the active pharmaceutical ingredient, or finish product with effective ingredients, and they always has in-active ingredients in finish product;5. Labeling: denotes all labels, instructions, package material and all of the word and picture with the finish product.6. Packaging material: denotes the material used to package the product excluding the container and seal;7. Finished product: denotes the veterinary drug with the finished packaging operation and the appearance tells the relevant information about the contents inside the package;8. Batch: denotes that follow the same manufacture indications, obtained specific quantified drugs or other substances with the identical property and quality; as for the consecutive process, it denotes the specific quantity produced within a certain period or the consistent quality within a certain limit;9. Batch number: the clear words, numbers, symbols or their combination attached sufficient to trace the complete information of the products or relative substances;10. Contents: denotes one of the following circumstances:(1) The unit quantity of the active ingredient contained in the finishproduct;(2) The potency of the finish product, i.e. the therapeutic effect confirmed by the proper experiments or sufficient clinic data;11. Fiber: denotes the substance with a length 3 times larger than the width;12. Non-fiber liberation filter: denotes the filter that prevents the fiber from entering any filtered solution, bulk or product by the proper pretreatments such as rinsing or flushing;13. Validation: denotes the action certified by documents which can prove that any procedure, manufacture process, machinery, bulk, action or system can definitely lead to the expected effect;14. active pharmaceutical ingredient: denotes the pharmacological active component or ingredient obtained via the physical or chemical treatment or the biotechnical process which may be employed to manufacture drugs, biomedicines or biotechnical products;15. Biotechnical product: denotes the product manufactured by biotechnological methods such as genetic recombination, cell fusion or microbes through cell culture and fermentation technology or tissue extract or the active material proliferation of embryos or animals. The biotechnical products are managed respectively by the reagents of veterinary drugs, veterinary biomedicines or veterinary diagnosis pursuant to the sources, ingredients and purposes;16. Biopharmaceutical: denotes the serum, antitoxin, vaccine, toxoid, and strain solution manufactured in accordance with microbiologic and immunologic theories.