GMP certification refers to the process that the provincial food and drug administration organizes GMP examiners to inspect all the links involved in the enterprise, such as personnel, training, factory facilities, production environment, sanitary conditions, material management, production management, quality management and sales management. And evaluate whether it meets the requirements of the specification. \ x0d \ "GMP" is the abbreviation of Good Manufacturing Practice in English, which means "good working practices" or "good manufacturing standards" in Chinese. It is an independent management system, paying special attention to product quality and the implementation of health and safety in the production process. It is a set of mandatory standards applicable to medicine, food and other industries, and requires enterprises to meet the hygiene and quality requirements in raw materials, personnel, facilities and equipment, production technology, packaging and transportation, quality control and so on. , form a set of operating norms to help enterprises improve the sanitary environment, and find out the problems existing in the production process in time and improve them. In short, GMP requires food production enterprises to have good production equipment, reasonable production technology, perfect quality management and strict testing system to ensure that the quality of final products (including food safety and hygiene) meets the requirements of laws and regulations. \ x0d \ x0d \ 1, responsibilities and authorities \ x0d \ x0d \ 1. 1 The State Administration of Medical Supplies is responsible for the national drug GMP certification. The Drug Certification Management Center of the State Administration of Pharmaceutical Products (hereinafter referred to as the "Bureau Certification Center") undertakes the specific work of drug GMP certification. \ x0d \ x0d \ 1.2 The drug administrations of all provinces, autonomous regions and municipalities directly under the Central Government are responsible for the preliminary examination and daily supervision and management of the application materials for drug GMP certification of pharmaceutical production enterprises within their respective jurisdictions. \ x0d \ x0d \ 2。 Certification application and data review \ x0d \ x0d \ 2. 1 The applicant shall apply for drug GMP certification to the drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government, and submit relevant materials at the same time in accordance with the provisions of the Measures for the Administration of Drug GMP Certification. The pharmaceutical supervisory and administrative departments of provinces, autonomous regions and municipalities directly under the Central Government shall, within 20 working days from the date of receiving the application materials, conduct a preliminary examination of the application materials, and submit the preliminary examination opinions and application materials to the Safety Supervision Department of the State Pharmaceutical Products Administration. \ x0d \ x0d \ 2.2 The certification application materials are accepted by the Safety Supervision Department of the Bureau, reviewed in form, and then forwarded to the Certification Center of the Bureau. \x0d\\x0d\ 2.3 After receiving the application materials, the Bureau Certification Center will conduct a technical review of the application materials. \ x0d \ x0d \ 2.4 The Bureau Certification Center shall put forward its review opinions within 20 working days from the date of receiving the application materials, and notify the applicant in writing. \x0d\\x0d\ 3。 Make an on-site inspection plan \ x0d \ x0d \ 3. 1 The unit that has passed the data review shall make an on-site inspection plan and organize the on-site inspection within 20 working days from the date of data review. The contents of the inspection plan should include the schedule, inspection items, inspection team members and division of labor, etc. The problems found in the data review that need to be verified should be included in the inspection scope. \ x0d \ x0d \ 3.2 Bureau Certification Center is responsible for sending on-site inspection notice to the inspected unit, and sending a copy to the provincial drug supervision and administration department, the unit where the inspection team members belong and the Bureau Safety Supervision Office. \x0d\\x0d\ 3.3 Generally, there are no more than three inspection teams, and the members of the inspection team should be GMP inspectors of the State Administration of Pharmaceutical Products. When forming an inspection team, inspectors should avoid GMP certification inspection of drugs in their respective jurisdictions. \x0d\\x0d\ 4。 On-site inspection \ x0d \ x0d \ 4. 1 Team leader is responsible for on-site inspection. \ \x0d\\x0d\ 4.2 The provincial drug supervision and administration department may send a person in charge of drug production supervision and administration as an observer to participate in the on-site inspection of drug GMP certification within its jurisdiction. \ x0d \ x0d \ 4.3 The Bureau Certification Center is responsible for organizing the GMP certification on-site inspection, sending personnel to participate in, supervise and coordinate the implementation of the inspection plan according to the situation of the inspected unit, and assisting the team leader in drafting the inspection report. \x0d\\x0d\ 4.4 The contents of the first meeting include: introducing the members of the inspection team; Check the notice statement; Confirm the scope of inspection; Implement the inspection plan; Be sure to check the escorts, etc. The inspector must be the person in charge of the enterprise or the person in charge of the production and quality management department, be familiar with the whole process of drug production, and be able to accurately answer the relevant questions raised by the inspection team. \x0d\\x0d\ 4.5 The inspection team shall investigate and collect evidence on the inspection items in strict accordance with the inspection plan. \ x0d \ x0d \ 4.6 The comprehensive evaluation inspection team evaluates the defective items found in the inspection according to the inspection evaluation standards, makes comprehensive evaluation results, and writes on-site inspection reports. When evaluating and summarizing, the inspected unit should avoid it. \ x0d \ x0d \ 4.7 The inspection report shall be signed by all members of the inspection team, accompanied by defective items, areas needing improvement, inspector's records, dissenting opinions and relevant materials. \ \x0d\\x0d\ 4.8 The inspection team read out the comprehensive evaluation results at the last meeting. The inspected unit may arrange relevant personnel to participate. \ x0d \ x0d \ 4.9 The inspected unit may put forward different opinions and make appropriate explanations on the defective items and evaluation results found in the inspection. Controversial issues must be verified when necessary. \x0d\\x0d\ 4. 10 The unqualified items and areas needing improvement found in the inspection must be signed by all members of the inspection team and the person in charge of the inspected unit, with each party holding one copy. \x0d\\x0d\ 4. 1 1 If there are any problems that cannot be identified, the inspection team shall make records, which shall be signed by all members of the inspection team and the person in charge of the inspected unit, with each party holding one copy. \ x0d \ x0d \ 5。 Audit of Inspection Report \ x0d \ x0d \ The Bureau Certification Center shall, within 20 working days from the date of receiving the on-site inspection report and related materials submitted by the inspection team, put forward audit opinions and send them to the Safety Supervision Department of the State Medical Device Administration. \x0d\\x0d\ Edit this certification approval 1. After being audited by the Bureau's Safety Supervision Department, it shall be reported to the Bureau's leaders for approval. The State Administration of Medical Devices shall make a decision on whether to approve or not within 20 working days from the date of receiving the audit opinions of the Bureau Certification Center. \x0d\\x0d\ 2。 For pharmaceutical production enterprises (workshops) whose examination and approval results are "qualified", the State Administration of Pharmaceutical Products will issue GMP certificates and make an announcement. \ x0d \ x0d \ drug GMP certificate: \ x0d \ x0d \ drug GMP certificate is valid for 5 years. The GMP certificate of newly established pharmaceutical manufacturing enterprises is valid for 1 year. Pharmaceutical production enterprises shall reapply for GMP certification six months before the expiration of the validity period. Apply for reexamination 3 months before the expiry of the drug GMP certificate of the newly-established drug production enterprise, and issue a drug GMP certificate with a validity period of 5 years after the reexamination \x0d\\x0d\ edit this GMP certification information \ x0d \1enterprise profile \ x0d \ \ x0d \ ◆ enterprise production address. \x0d\\x0d\ ◆ Contact, fax and telephone (including 24-hour contact and telephone in case of serious drug injury or recall). \x0d\\x0d\ 1.2 enterprise drug production \ x0d \ x0d \◆ Briefly describe the production activities approved by the (food) drug supervision and administration department, including information on imported and sub-packaged drugs, exported drugs and drugs licensed from abroad; \ \x0d\\x0d\ ◆ Business license and pharmaceutical production license, and copies of relevant certification documents issued by overseas institutions shall be attached for export; \x0d\\x0d\ ◆ All varieties that have obtained the approval number (it can be filled in by factories at different addresses, and indicate whether they are produced all the year round, with the output list of the last three years attached); \x0d\\x0d\ ◆ Is there any operation to handle highly toxic, active and allergic materials such as sex hormones at the production address? If so, it should be listed and marked in the annex. \x0d\\x0d\ 1.3 Scope of this application for drug GMP certification \ x0d \ x0d \ ◆ List the production lines, production dosage forms and varieties of this application for drug GMP certification, and attach copies of registration approval documents of related products; \ x0d \ x0d \ ◆ The latest inspection of the production line by the (food) drug supervision and administration department (including inspection date, inspection results, defects and rectification, with relevant GMP certificates attached). If the production line has passed the GMP inspection of foreign drugs, the inspection situation should be provided together. \x0d\\x0d\ 1.4 Main changes since the last GMP certification \x0d\\x0d\ ◆ Briefly describe the changes of key personnel, equipment and facilities and varieties after the last certification inspection. \ x0d \ x0d \ 2 Enterprise's quality management system \ x0d \ x0d \ 2. 1 Description of enterprise's quality management system \ x0d \ x0d \ ◆ Relevant management responsibilities of quality management system, including those of senior managers, quality management leaders, quality assignees and quality assurance departments; \x0d\\x0d\ ◆ Briefly describe the elements of the quality management system, such as organization, main procedures and processes. \x0d\\x0d\ 2.2 finished product release procedure \x0d\\x0d\ ◆ General description and basic information (qualifications, etc.) of the release procedure. ) personnel responsible for the release. \ \x0d\\x0d\ 2.3 Supplier management and commissioned production inspection \ \x0d\\x0d\ ◆ Summarize the requirements of supplier management and the quality risk management methods used in the review; \x0d\\x0d\ ◆ Briefly describe the situation of entrusted production; (if any) \ x0d \ x0d \ ◆ Briefly describe the entrusted inspection. (if any) \ x0d \ x0d \ 2.4 Quality risk management measures of the enterprise \ x0d \ x0d \ ◆ Briefly describe the quality risk management policy of the enterprise; \ x0d \ x0d \ ◆ The scope and focus of quality risk management activities, and the process of risk identification, evaluation, control, communication and audit under the quality risk management system. \x0d\\x0d\ 2.5 Annual product quality retrospective analysis \ x0d \ x0d \ ◆ Annual product quality retrospective analysis conducted by enterprises and key points of investigation. \ x0d \ x0d \ 3 Personnel \ x0d \ 3.1Organization charts including quality assurance, production and quality control (including senior management personnel), including the organization charts of quality assurance, production and quality control departments respectively; \x0d\\x0d\ 3.2 Qualifications of key personnel of the enterprise and key technical personnel engaged in quality assurance, production and quality control; \x0d\\x0d\ 3.3 Number of employees in various departments such as quality assurance, production, quality control, warehousing and delivery. \ x0d \ x0d \ 4 plant, facilities and equipment \ x0d \ 4. 1 plant \ x0d \ x0d \ ◆ Briefly describe the completion and use time and type of the building (including structure, internal and external surface materials, etc. ) and site area; \x0d\\x0d\ ◆ General layout of the factory, layout of the production area and flow chart, indicating the proportion. The cleanliness level of the room and the pressure difference between adjacent rooms should be marked, and the production activities carried out in the room can be indicated; \x0d\\x0d\ ◆ Briefly describe the layout of all production lines within the scope of applying for certification; \x0d\\x0d\ ◆ Briefly describe warehouses, storage areas and special storage conditions. \ x0d \ x0d \ 4.1.1Brief introduction of air conditioning purification system \ x0d \ ◆ Working principle, design standard and operation of air conditioning purification system, such as intake air volume, temperature, humidity, pressure difference, air exchange times, return air utilization rate, etc. \x0d\\x0d\ 4. 1.2 Brief introduction of water system \x0d\\x0d\ ◆ Working principle, design standard, operation and schematic diagram of water system. \x0d\\x0d\ 4. 1.3 Brief introduction of other public facilities \ x0d \ x0d \ ◆ Working principle, design standard and operation of other public facilities such as compressed air and nitrogen. \x0d\\x0d\ 4.2 Equipment \ x0d \ x0d \ 4.2. 1 List the main instruments and equipment for production and inspection. \x0d\\x0d\ 4.2.2 Cleaning and disinfection \ x0d \ x0d \ ◆ Briefly describe the methods and verification of cleaning, disinfection and drug use on the surface of direct contact equipment. \x0d\\x0d\ 4.2.3 Key computerized systems related to drug production quality \ x0d \ x0d \ ◆ Briefly describe the design and application verification of key computerized systems related to drug production quality. \x0d\\x0d\ 5 file \x0d\\x0d\ ◆ Describe the file system of the enterprise; \x0d\\x0d\ ◆ Briefly describe the system of document drafting, revision, approval, distribution, control and filing. \x0d\\x0d\ 6 Production situation of products produced \ x0d \ 6. 1 \x0d\\x0d\ ◆ Overview of products produced (brief description); \x0d\\x0d\ ◆ The process flow chart of the dosage forms and varieties of this application, and indicate the main quality control points and items. \x0d\\x0d\ 6.2 Process verification \x0d\\x0d\ ◆ Briefly describe the principle and general situation of process verification; \x0d\\x0d\ ◆ Briefly describe the principle of rework and reprocessing. \ x0d \ x0d \ 6.3 Material management and storage \ x0d \ x0d \◆ Handling of raw and auxiliary materials, packaging materials, semi-finished products and finished products, such as sampling, inspection, release and storage; \ \x0d\\x0d\ ◆ Disposal of unqualified materials and products. \x0d\\x0d\ 7 quality control \x0d\\x0d\ ◆ Describe all activities carried out by the quality control laboratory of the enterprise, including inspection standards, methods and verification. \x0d\\x0d\ 8 Transportation, complaint and recall \ x0d \ 8. 1 transportation \ \x0d\\x0d\ ◆ Briefly describe the control required by the product during transportation, such as temperature/humidity control; \x0d\\x0d\ ◆ Methods to ensure product traceability. \x0d\\x0d\ 8.2 Complaints and recalls \x0d\\x0d\ ◆ Briefly describe the procedures for handling complaints and recalls. \x0d\\x0d\ 9 Self-inspection \ x0d \ ◆ Briefly describe the self-inspection system, focusing on the regional selection criteria in the planned inspection, the implementation and rectification of self-inspection. \x0d\\x0d\ Edit the GMP certification process in this paragraph 1, the reporting enterprise submits the certification application and application materials to the reception hall of the provincial bureau \ x0d \ x0d \ 2, the drug safety supervision department of the provincial bureau conducts a formal review of the application materials (5 working days) \x0d\\x0d\ 3, and the certification center conducts a technical review of the application materials (66d The certification center formulates the on-site inspection plan (10 working days) \ x0d \ x0d \ 5. Provincial Bureau Approval Scheme (10 working days) \x0d\\x0d\ 6. The Certification Center organizes and implements on-site inspection of certification (10 working days) \ 7. The certification center conducts a preliminary examination of the on-site inspection report (10 working day) \ x0d \ x0d \ 8. Provincial Bureau approves the preliminary examination opinions (10 working days) \ x0d \ x0d \ 9. The report is submitted to the National Bureau for review and announcement (10 working day).