Part 2 Good Manufacturing Practices for Pharmaceuticals
Chapter 2 Good Manufacturing Practices for Chinese Herbal Medicines
Section 4 Facilities
Facilities at Chinese herbal medicine factories used for the manufacture, processing, re-packaging, packaging and storage of products shall be appropriately designed, sized and located for ease of usage, cleaning and maintenance.
Facilities needed for the production of different dosage forms shall be positioned according to manufacturing process sequence.
The surfaces of facilities at Chinese herbal medicine factories that come into direct contact with raw materials, semi-finished products, intermediate products or products shall be made of non-reactive, non-releasing and non-adsorptive materials; where any process requires the use of lubricants, coolants or other similar substance, aforesaid substances may not come into contact with raw materials, product containers, caps, semi-finished products, intermediate products or products.
Facilities and appliances at Chinese herbal medicine factories used for the manufacturing, processing, re-packaging, packaging, and storage of the products shall be cleaned and maintained regularly, and written operation procedures shall be established.
The production capacities of mechanical facilities used at Chinese herbal medicine factories to produce a single product shall be carefully coordinated to ensure consistency of product quality.
Automated machinery and electronic facilities used in the manufacturing process, as well as software and equipment related to computers or to the manufacture, processing, re-packaging, packaging or storage of pharmaceuticals, shall be regularly recalibrated, inspected, examined and maintained.
Computer systems used to control production and production management records shall be properly maintained, and alterations may not be made to aforesaid systems without permission from the personnel in charge; all data that is input or printed shall be checked for accuracy, and its period of validity shall be determined based on the complexity and reliability of the computer system.
Air used by drying facilities during the manufacturing process shall first be treated with a purification filter.
Facilities used to manufacture pharmaceuticals for internal and external use shall be kept strictly separate, and may not be used interchangeably.
Pharmaceutical factories shall install weighing facilities that comply with regulations, and shall recalibrate aforesaidfacilities regularly.
Chinese herbal medicine factories shall keep facilities and equipment for the production of pharmaceuticals for human and animal use separate, and these two types of production may not be carried out in the same structure unless the two areas are completely separated. However, pharmaceuticals for animal use that comply with the standards governing drugs for human use are not subject to this restriction.
Chinese herbal medicine factories shall, in accordance with the requirements of the products being manufactured, install necessary manufacturing, processing, re-packaging and packaging facilities.
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.