What types of GMP documents are included?

1. application documents: application for GMP certification of drugs (in quadruplicate); Copies of the License for Pharmaceutical Manufacturing Enterprises and the Business License.

2. Description document: self-inspection of drug production management and quality management (including enterprise profile and historical evolution, production and quality management, and correction of defective items in previous certifications).

3. Institutional documents: the organizational chart of the pharmaceutical production enterprise (indicating the name, relationship and person in charge of the department).

4. Registration documents: resumes of the heads of pharmaceutical production enterprises and departments; Registration forms for pharmaceutical and related professional and technical personnel, engineering and technical personnel and skilled workers who have passed the examination according to law, and indicate their subordinate departments and posts; Table of the proportion of senior, middle and junior technicians to all employees.

5. Charts and documents: the surrounding environment diagram, general layout diagram, storage layout diagram and quality inspection site layout diagram of the pharmaceutical production enterprise.

Baidu encyclopedia -GMP