Pharmaceutical factories shall, as needed, establish employee lounges and shower rooms outside of work areas.
Manufacturing and processing areas shall be installed with appropriate lavatory facilities, and wastewater, garbage and other waste materials produced in said areas shall be treated in a safe and sanitary manner. Lavatory facilities shall be separated from work areas.
Article 45. Pharmaceutical factories shall, as needed, install facilities for the processing of general use and wastewater, and facilities for the production of boiler water or distilled water. Water supply facilities shall be kept from contaminating products.
Article 46. Container washing facilities shall be installed; where container washing facilities are used to wash containers for eye drops, injectables, or biopharmaceutical or biotechnology products, special care shall be taken to prevent contamination, and said facilities shall be installed away from other container washing facilities.
Article 47. Pharmaceutical factories shall carry out the manufacturing, processing and re-packaging of sterile products in aseptic room areas.
The aseptic room areas mentioned in the preceding Paragraph shall, as needed, be installed with the following facilities:
(1) Floors, walls and ceilings that are easily cleaned and disinfected;
(2) Temperature and humidity control systems;
(3) High performance air filtration systems capable of maintaining positive pressure;
(4) Work area surveillance systems;
(5) Cleaning, disinfection, and other systems for maintaining sterile conditions.
Operation areas for sterile products that cannot be sterilized during the final stage of production must not only comply with the preceding Paragraph, but must also be installed with high performance air filters and laminar flow facilities for the circulation of sterile air. Furthermore, excessive traffic (personnel and objects) into and out of said areas shall be avoided.
Chapter 4 Facilities
Article 48. Facilities at pharmaceutical factories used for the manufacture, processing, re-packaging, packaging and storage of products shall be appropriately designed, sized and located for ease of use, cleaning and maintenance.
Facilities needed for the production of different dosage forms shall be positioned according to manufacturing process sequence.
Article 49. The surfaces of facilities at pharmaceutical 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, said substances may not come into contact with raw materials, product containers, caps, semi-finished products, intermediate products or products.
Article 50. Facilities and appliances at pharmaceutical factories used for the manufacture, processing, re-packaging, packaging and storage of products shall be regularly cleaned and maintained, and operational procedures shall be established in writing.
Facilities and appliances in aseptic room areas shall be made of materials that are easily cleaned, dried and disinfected, and shall be regularly cleaned, disinfected and maintained.
Article 51. The production capacities of mechanical facilities used at pharmaceutical 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 said 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 said facilities regularly.
Article 52. Where a pharmaceutical factory manufactures, processes or packs injectables, and has not installed filtration facilities capable of filtering out fibers, said factory may not use liquid filtration facilities that can possibly release fibers.
Article 53. Pharmaceutical 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.
Article 54. Pharmaceutical factories shall, in accordance with the requirements of the products being manufactured, install necessary manufacturing, processing, re-packaging and packaging facilities.
Article 55. Pharmaceutical 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 said 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.
Where eye preparations, injectable drugs, biopharmaceutical or biotechnology products are produced, areas, facilities and equipment necessary for conducting plate count, sterility tests and other tests shall be installed as needed; said areas and facilities shall be equipped with necessary culture mediums and control strains.
Where injectable drugs and biopharmaceutical or biotechnology products are produced, areas, facilities and equipment necessary for conducting pyrogen tests shall be installed as needed; said areas and facilities shall be equipped with necessary rabbits and breeding areas.
Where antibiotics and biopharmaceutical or biotechnology products are produced, areas, facilities and equipment necessary for conducting safety tests shall be installed as needed; said areas and facilities shall be equipped with necessary animals and breeding and observation areas.
Where antibiotics, hormones and biopharmaceutical or biotechnology products are produced, areas, facilities and equipment necessary for conducting bioassays shall be installed as needed.
The specifications of aseptic rooms and dissection laboratories shall be determined in accordance with the requirements of the tasks to be performed; microorganism strains, culture mediums and animals necessary for conducting bioassays shall be adequately stocked and maintained.