新版gmp培训（New GMP training）.doc

新版gmp培训（New GMP training） 1. the standard for the quality control of pharmaceutical production (GMP) is the basic standard for drug production and quality control. The new drug GMP total of 14 chapters, 313. 2., the new version of the drug GMP will come into effect on March 1, 2011, since March 1, 2011, the new pharmaceutical manufacturing enterprises, pharmaceutical production enterprises new (alteration, expansion) workshop should meet the new version of the drug GMP requirements. Existing pharmaceutical production enterprises will be given no more than 5 years of transition period, and according to product risk level, according to categories, phase by stage to achieve the requirements of the new version of the drug GMP. 3. this specification as a part of the quality management system, is the basic requirement for manufacturing management and quality control, to minimize pollution, cross contamination and mix up and error risk in drug production process, to ensure continuous and stable production of intended use and in accordance with the requirements of the drug registration. 4. all personnel should be clear and understand their responsibilities, familiar with their responsibilities related requirements, and receive the necessary training, including pre job training and continuous training. 5. enterprises should take appropriate measures to avoid surface wounds, infectious diseases or other diseases that may contaminate the medicines, and engage in direct contact with the production of drugs. 6. personnel who enter clean production shall not make up or wear ornaments. 7. production and storage areas shall be prohibited from smoking and eating, and non food products such as food, beverages, cigarettes and personal drugs shall be prohibited. 8. the operator shall avoid direct contact with the naked hand and direct contact with the drug, including the surface of the material and equipment. 9. the pressure difference between clean areas, non clean zones and clean zon