Guidelines of Good Manufacture Practice (GMP)for Veterinary Drugs Manufacturers Article 38

The manufacture and quality control records of all products including the packaging and labeling control records shall be tested by the Quality Control Department to ensure the conformity of the products to the existing written operating procedures prior to the release or distribution.A thorough investigation shall be exercised on the batch of product whether it is sold or not if the percentage of the theoretic yield exceeds the maximal or minimal percentage prescribed by the manufacture control standard manual or there is any unexplained difference, or there is any inconformity of products or materials. The investigation shall extend to the identical products of other batches or other products relating to the difference concerned.The investigation in the preceding Paragraph shall be recorded in written form and shall include the conclusion and treatments.