Guidelines of Good Manufacture Practice (GMP)for Veterinary Drugs Manufacturers Article 32

The test shall be exercised on each batch of products to ensure conformity to the existing specifications.The relevant batch-by-batch test shall be exercised on the products which shall not contain any microbe if necessary.As for the batches of products or finished products, and the raw materials of the effective ingredients, there shall be a representative reserved sample; moreover, the reserved sample of the product or finished products shall be kept in conditions identical with the labels.The reserved quantity shall be 2 times and more than the demanded quantity required for all prescribed inspections; however, the quantity for the aseptic test shall be prescribed in accordance with the demands The reserved sample shall be kept at least one year after the expiry date of the product concerned.