Pharmaceutical Good Manufacturing Practice Regulations Article 21

Chinese herbal medicine factories shall, in accordance with their specification testing requirements for raw materials, semi-finished products, intermediate products and products, establish testing departments and appropriate testing facilities. However, if tests are conducted on a contract basis by an organization approved by the competent authority, in accordance with the Contract Drug Manufacturing and Testing Operating Principles, and clear documentation is provided, establishment of aforesaid facilities may be waived.Testing departments shall include testing and instrument laboratories. Instrument laboratories shall be separate from testing laboratories, and shall be kept at an appropriate temperature and level of humidity and air purity; testing laboratories shall be installed with sufficient and easy to use test benches, test stands, drug cabinets, fume hoods, water supply and washing facilities, as well as electric heating, thermostatic and drying facilities, and shall also be stocked with utensils and containers, chemical reagents and solutions, standard solutions and other necessary items.Areas, facilities and equipment necessary for total viable count and other microorganism tests shall be installed as needed; microorganism strains, culture mediums, and animals necessary for conducting bioassays shall be adequately stocked and maintained.For pyrogen testing, priority shall be given to replacing testing on live animals with alternative techniques.