Pharmaceutical Good Manufacturing Practice Regulations Article 44

Chinese herbal medicine factories shall test every batch of products to ensure that they are in compliance with established specifications; each batch of products that must not contain harmful microorganisms shall, where necessary, be subjected to appropriate tests.Representative samples shall be removed from each batch of products or end products, and taken from the raw materials containing active ingredients used in making aforesaid products, and placed in reserve; aforesaid reserve samples shall be stored under indicated conditions, and shall be of at least twice the quantity needed for all required tests.Reserve samples shall be retained until one year after the expiration date of the product from which it was taken; reserve samples of products that do not require expiration dates shall be kept for at least three years after the date of dispatch of the last batch of aforesaid product.