Guidelines of Good Manufacture Practice (GMP)for Veterinary Drugs Manufacturers Article 36

There shall be a manufacture batch record of each batch of products, and the complete data of the manufacture and control concerned.The Manufacturer shall make a precise copy of the manufacture batch record and check the precision along with the signature and date noted.The Manufacturer shall record in detail the key steps of the processes of manufacture, processing, packaging or storage and include the circumstances as follows:1. The date and product batch number;2. The labeling of raw materials, in process products or intermediate products;3. The identification between the major equipment and production lines;4. The weight and volume of materials used in the processing process;5. The result of the manufacture process and testing result;6. The pre-use and post-use check of labeling and packaging workplaces;7. The percentage of actual yield and the theoretic yield in the proper stage in the manufacture process;8. The complete labeling control records, including samples or copies of all labeling;9. The labeling and consumption of the product containers and seals;10. The sampling records;11. The operating date, time, operator and the supervisor’s or auditor’s signature and date of the key steps of the operating processes.