Pharmaceutical Good Manufacturing Practice Regulations Article 34

In regard to the quantities of raw materials used by Chinese herbal medicine factories in the manufacture of products, the amounts of active ingredients in each product batch may not fall below the nominal quantity.Weighing, dividing and other procedures carried out on raw materials shall be performed in designated segregation areas, and shall be appropriately supervised and controlled.Documented operational procedures shall include detailed test and control procedures for representative samples from each batch of semi-finished or intermediate products.During the manufacturing and production process, the quality control departments of pharmaceutical factories shall carry out tests on semi-finished or intermediate products in accordance with established test procedures, thereby determining whether to approve aforesaid products for use; semi-finished or intermediate products that are not approved for use shall be labeled to this effect and kept isolated.