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.
Extended data:
Features:
The new GMP terms are more specific, instructive and operable; The regulations on production conditions and management system are more comprehensive and specific, which further ensures the safety, stability and unity of drug quality from the production link.
The characteristics of the new version of drug GMP are firstly reflected in strengthening the requirements for software.
First, the quality management system of pharmaceutical production has been strengthened, and the requirements for enterprise quality management software have been greatly improved. The requirements for building an effective quality management system are refined, the control and management of key links in drug production are strengthened, and the quality management level of enterprises is improved.
The second is to comprehensively strengthen the quality requirements of employees. The provisions and contents of quality requirements for personnel engaged in drug production quality management have been added, and the responsibilities have been further clarified.
Baidu encyclopedia -GMP