Good Manufacturing Practices (GMP) for Pharmaceutical Products (Revised in 1998)

Good Manufacturing Practices (GMP) for Pharmaceutical Products (Revised in 1998)


Good Manufacturing Practices (GMP) for Pharmaceutical Products (Revised in 1998)

Order of the State Drug Administration No. 9

June 18, 1999

The Good Manufacturing Practices for Pharmaceutical Products (Revised in 1998) ("the GMP"), which were adopted at the executive meeting of the State Drug Administration (SDA) on March 18, 1999, are promulgated hereby and shall come into effect as of August 1, 1999.

Director of the State Drug Administration: Zheng Xiaoyu

Good Manufacturing Practices (GMP) for Pharmaceutical Products (Revised in 1998)

Chapter I General Provisions

Article 1 The GMP are formulated in accordance with the Law of the People's Republic of China on the Administration of Drugs.

Article 2 The GMP are the fundamental guideline for the manufacturing and quality control of drugs. The GMP shall be applicable to all the manufacturing processes of drug preparations and to the key manufacturing processes of active pharmaceutical ingredients which may impact the quality of finished products.

Chapter II Organization and Personnel

Article 3 Drug production enterprises shall establish production and quality control departments. The responsibilities of such departments at all levels and personnel thereof shall be clarified, and all departments shall be staffed with an appropriate number of management and technical personnel with professional knowledge, manufacturing experience and organizational ability and matching with production of drugs.

Article 4 The enterprise personnel responsible for supervision of drug manufacturing and quality control shall hold a college degree in medicine, pharmaceuticals or related disciplines, and have appropriate experiences in drug manufacturing and quality control. They shall be responsible for the implementation of the GMP and the quality of products.

Article 5 Leaders of the drug manufacturing and quality control departments shall hold a college degree in medicine, pharmaceuticals or related disciplines, have actual experience in production and quality control, and have the ability to correctly judge and settle practical problems in drug manufacturing and quality control.
Leaders of the drug manufacturing and quality control departments shall be independent of each other.

Article 6 Personnel engaged in drug manufacturing and quality inspection shall have been professionally and technically trained so as to acquire the basic theory and practical operating skills.
Personnel engaged in the manufacturing and quality inspection of drugs with high organic activity, high toxicity, strong contamination, high sensitivity and other special requirements shall have undergone corresponding professional technical training.

Article 7 Personnel at all levels who are engaged in drug manufacturing shall be trained and have passed examinations in accordance with the requirements hereof.

Chapter III Factory buildings and Facilities

Article 8 A drug production enterprise shall be located in a clean environment. The surface of the flooring and roads and transportation within the enterprise may not be a source of contamination to drug products. The general lay-out of the production, administration, living and ancillary areas of the enterprise shall be appropriately arranged and not interfere with each other.

Article 9 Factory buildings of a drug production enterprise shall be appropriately located in accordance with the technological process and required air cleanliness levels. The manufacturing operations undertaken in the same building or with nearby factory building may not interfere with each other.

Article 10 Factory buildings of a drug production enterprise shall be equipped with facilities to protect against the entrance of vermin and other animals.

Article 11 For the design and construction of factory buildings, the ease and convenience to clean shall be taken into consideration. The interior surfaces of the clean rooms (areas) shall be smooth, without cracks and with airtight junction points. The interior surfaces may not shed any particulate granules and shall be able to withstand washing and disinfecting. The joints between walls and floors shall be preferably constructed with round corners or by other means so as to reduce the collection of dust and for ease of cleaning.

Article 12 In production and storage areas, there shall be adequate floor and air space, as is appropriate for the production scale, for the orderly placement of equipments and materials so as to facilitate production, operations, storage of materials, in-process products, finished products and those under quarantine, and to the greatest degree possible minimize errors and cross-contamination.

Article 13 All piping, lighting, ventilation points and other public facilities in clean rooms (areas) shall be so designed and installed as to avoid areas difficult to clean.

Article 14 Clean rooms (areas) shall be equipped with sufficient lighting as is required by the production requirements. Illumination for main production rooms shall be 300 Lux. For production areas with special requirements, appropriate lighting shall be installed. Emergency lighting shall be provided in factory buildings.

Article 15 Air supplied into clean rooms (areas) must be purified and the cleanliness level of air shall be classified in accordance with the requirements of the production process. The number of microorganisms and particulates in the air of the clean rooms (areas) shall be tested on a regular basis and the results shall be recorded and archived.

Article 16 The windows, ceilings as well as joints between entering pipes, ventilation, light fixtures and the walls or ceilings in clean rooms (areas) shall be airtight. The static pressure difference between areas of different cleanliness levels shall be maintained at more than 5 Pa, the static pressure difference between clean rooms (areas) and the atmosphere outside shall be maintained at more than 10 Pa and devices for showing pressure difference shall be installed.

Article 17 The temperature and relative humidity in clean rooms (areas) shall comply with the requirements of drug manufacturing processes. When there are no special requirements, the temperature and relative humidity may be controlled respectively at 18-26 degrees Celsius and 45-65%.

Article 18 Sinks and drains in clean rooms (areas) shall be so installed as to avoid any threat of polluting drugs.

Article 19 Measures shall be taken to protect against cross contamination of personnel and materials entering or leaving clean rooms (areas) of different cleanliness levels.

Article 20 Separate factory buildings and facilities must be used in the production of highly sensitive drugs, such as penicillin. In filling rooms of these drugs, a relatively negative pressure shall be maintained. Before being discharged outside the room, the used steam shall be properly cleaned so as to comply with the requirements. The opening for the discharge of used steam shall be far away from the air intake of other air cleaning systems.
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