药品生产企业GMP认证申报资料技术要求（Technical requirements for GMP certification application materials of pharmaceutical manufacturing enterprises）.docVIP

药品生产企业GMP认证申报资料技术要求（Technical requirements for GMP certification application materials of pharmaceutical manufacturing enterprises） Technical requirements for GMP certification application materials of pharmaceutical manufacturing enterprises I. application for certification The name of the business should be consistent with the name of the enterprise on the permit; The registration address should be in line with the registered address on the license; The production address shall be in conformity with the production address on the permit; The scope of application shall be within the scope of the permit; The workshop name and production line shall be consistent with the drug production workshop described in the data; The pretreatment workshop and the extraction workshop should be indicated; The washing workshop with animal organs and tissues shall be indicated; Each item of the form should be filled (without any entry, the word no, and the number 0) Two, license, copy of business license The certificate shall be valid within the period of validity Three, enterprise production management and quality management self-examination 1., enterprise profiles and historical evolution should include the following: Enterprises formerly or predecessor, changed to the companys time, the company covers an area of green area, green rate, etc.; Through the GMP certification situation; The application of the certification workshop completion time, area, purification area, annual design and production capacity, workshop production varieties and so on 2. enterprise GMP implementation should include the following content: The last revision of the certification project, the expiration of certification, should provide the original certification, GMP certificate copy and defect project rectification; Personnel training; The person in charge of the enterprise, production, quality management personnel and other technical personnel; The corresponding workshop and production line of the certifi