Good Manufacturing Practice (GMP) for Pharmaceutical Products
Shanghai Nina Environmental Technology Co., Ltd. 2008-10-28 0:17:43
Good Manufacturing Practice (GMP) for Pharmaceutical Products
(Revised in 1998)
Chapter One General Provisions
Article 1: This regulation is formulated according to the provisions of the "People's Republic of China Drug Administration Law."
Article 2: This standard is the basic guideline for drug production and quality management. It applies to the entire process of drug formulation production, as well as key procedures in raw material production that affect the quality of finished products.
Chapter Two Organization and Personnel
Article 3: Drug manufacturing enterprises should establish production and quality management organizations. At all levels, institutions and personnel should have clear responsibilities, and be equipped with a certain number of managers and technical personnel who have professional knowledge, production experience, and organizational capabilities corresponding to drug production.
Article 4: The person in charge of drug production management and quality management in the enterprise should have a college degree or above in medicine or related fields, have experience in drug production and quality management, and be responsible for the implementation of this standard and product quality.
Article 5: The heads of the drug production management department and the quality management department should have a college degree or above in medicine or related fields, have practical experience in drug production and quality management, and be capable of making correct judgments and handling actual problems in drug production and quality management.
The heads of the drug production management department and the quality management department shall not concurrently hold each other's positions.
Article 6: Personnel engaged in drug production operations and quality inspections should receive specialized technical training and possess basic theoretical knowledge and practical operational skills.
Personnel engaged in the production operations and quality inspections of highly biologically active, highly toxic, highly polluting, highly sensitizing drugs, and drugs with special requirements should undergo appropriate professional technical training.
Article 7: Personnel at all levels engaged in drug production should be trained and evaluated according to the requirements of this standard.
Chapter Three Premises and Facilities
Article 8: Drug manufacturing enterprises must have a clean production environment; the ground, road surface, and transportation within the factory area should not cause pollution to drug production. The overall layout of production, administration, living, and auxiliary areas should be reasonable and not interfere with each other.
Article 9: The factory building should be reasonably laid out according to the production process flow and the required air cleanliness level. Production operations within the same factory building and between adjacent factory buildings should not interfere with each other.
Article 10: The factory building should have facilities to prevent insects and other animals from entering.
Article 11: When designing and constructing the factory building, it should be considered easy to conduct cleaning work. The inner surface of the clean room (area) should be flat, smooth, without cracks, tightly sealed interfaces, no particle shedding, and able to withstand cleaning and disinfection. The junction between walls and floors should preferably be arc-shaped or other measures taken to reduce dust accumulation and facilitate cleaning.
Article 12: The production area and storage area should have an area and space commensurate with the scale of production to accommodate equipment and materials, facilitate production operations, store materials, intermediate products, test samples, and finished products, and minimize errors and cross-contamination to the greatest extent possible.
Article 13: Various pipelines, lamps, vents, and other public facilities in the clean room (area) should be considered during design and installation to avoid areas that are difficult to clean during use.
Article 14: The clean room (area) should provide sufficient lighting according to production requirements. The illuminance of the main working area is preferably 300 lux; local lighting can be provided for areas with special illuminance requirements. The factory building should have emergency lighting facilities.
Article 15: Air entering the clean room (area) must be purified, and the air cleanliness level should be divided according to the production process requirements. The microbial count and dust particle count in the air of the clean room (area) should be regularly monitored, and the monitoring results should be recorded and archived.
Article 16: Windows, ceilings, and pipelines, vents, lamps entering the clean room (area), and the connection parts between them and walls or ceilings should be sealed. The static pressure difference between adjacent rooms with different air cleanliness levels should be greater than 5 Pascals, and the static pressure difference between the clean room (area) and outdoor atmosphere should be greater than 10 Pascals, and there should be devices indicating the pressure difference.
Article 17: The temperature and relative humidity of the clean room (area) should be compatible with the drug production process requirements. If there are no special requirements, the temperature should be controlled between 18～26℃, and the relative humidity should be controlled between 45～65％.
Article 18: Water tanks and floor drains installed in the clean room (area) should not contaminate the drugs.
Article 19: There should be measures to prevent cross-contamination when people and materials enter and exit clean rooms (areas) with different air cleanliness levels.
Article 20: The production of highly sensitizing drugs such as penicillin must use independent factories and facilities. The filling room should maintain relative negative pressure. Exhaust gas discharged to the outdoors should be purified and meet requirements. Exhaust vents should be far from other air purification system intake vents. The production of β-lactam structure drugs must use dedicated equipment and independent air purification systems, and be strictly separated from other drug production areas.
Article 21: The production plant for contraceptive drugs should be separate from other drug production plants, and be equipped with an independent, dedicated air purification system. The production of hormone and anti-tumor chemical drugs should avoid using the same equipment and air purification system as other drugs; if unavoidable, effective protective measures and necessary validation should be adopted.
The production, packaging, and storage of radioactive drugs should use dedicated, safe equipment. The exhaust air from the production area should not be recirculated, and the exhaust should avoid containing radioactive particles, complying with national radiation protection requirements and regulations.
Article 22: The processing or filling of production strains and toxins, non-production strains and toxins, strong toxins and weak toxins, dead toxins and live toxins, pre-detoxified and post-detoxified products, live vaccines and inactivated vaccines, human blood products, preventive products, etc., should not be carried out simultaneously in the same production plant. Their storage should be strictly separated. The treatment and filling of different types of live vaccines should be separated from each other. The area for strong toxin microorganisms and spore products should maintain relative negative pressure compared to adjacent areas and have an independent air purification system.
Article 23: The preliminary treatment, extraction, concentration of medicinal materials, and the washing or treatment of animal organs and tissues should be strictly separated from their preparation production.
The steaming, frying, roasting, calcining, etc., of medicinal materials should have good ventilation, smoke removal, dust removal, and cooling facilities. Screening, slicing, pulverizing, etc., should have effective dust removal and exhaust facilities.
Article 24: Dust prevention and dust capture facilities may be necessary for the factory when needed.
Article 25: Air, compressed air, and inert gases that come into direct contact with drugs should be purified and meet production requirements.
Article 26: The warehouse area should be kept clean and dry. Lighting, ventilation, and other facilities, as well as temperature and humidity control, should meet storage requirements and be regularly monitored.
A sample-taking room can be set up in the warehouse area, and the air cleanliness level of the sampling environment should be consistent with production requirements. If sampling is not done in the sample-taking room, measures to prevent contamination and cross-contamination should be taken during sampling.
Article 27: According to the requirements of the drug production process, the weighing room and preparation room set up in the clean room (area) should have an air cleanliness level consistent with production requirements and have dust-capture and cross-contamination prevention facilities.
Article 28: The inspection room, Chinese medicine specimen room, sample observation room, and other various laboratories set up by the quality management department according to needs should be separated from the drug production area. Biological testing, microbial testing, and radioactive isotope testing should be conducted in separate rooms.
Article 29: Instruments and meters with special requirements should be placed in dedicated instrument rooms and have facilities to prevent static electricity, vibration, humidity, or other external factors affecting them.
Article 30: The experimental animal house should be strictly separated from other areas, and its design and construction should comply with relevant national regulations.