GMP的基本原则(国外英语资料).doc

GMP的基本原则 The basic principles of GMP The basic principles have the following 17 points: (1) pharmaceutical producing enterprises must have the enough qualified and suitable to the medicine production and technical personnel for pharmaceutical production and quality management, and clearly understand their own responsibilities; (2) the operator should be trained to operate correctly according to the regulations. (3) to ensure the production and control of the approved quality standards; (4) the production orders should be issued in accordance with each batch of production tasks, and the production schedule shall not be substituted for the production orders; (5) all production process should be according to the technological procedures approved by the, the system of inspections according to the experience, and prove that can be produced in accordance with the requirements for quality and its specifications drugs; (6) to ensure that the production facilities, environment, production facilities and hygiene meet requirements; (7) materials, containers and labels required for compliance with the requirements; (8) suitable storage and transport equipment; (9) effective control and management of the full production process; (10) to verify the key steps in production processing and the important changes produced by processing; (11) qualified quality inspectors, equipment and laboratories; (12) production manual or recorder used in the production records, to prove that the completed all production step is to determine the procedures and instructions required, product quality and quantity of the desired, any deviation should be recorded and investigated; (14) the risk of the quality of the storage and sale of the product shall be minimized; (15) to establish an effective system for the withdrawal of any number of products from the sales and supply channels; (16) to understand the users opinions of the market products, to investigate the causes of the quality problems, to put f