1, GMP certification is the embodiment of total quality management in pharmaceutical industry.
2. According to different responsibilities of quality certification, the types of product quality certification can be divided into self-certification, user certification and third-party certification. According to the different contents of certification, it can be divided into quality certification, system certification and safety certification. Drugs are related to people's life safety, so drug certification belongs to safety certification and is mandatory.
3.GMP is an international GMP that embodies the new concepts of quality management and quality assurance. It is characterized by combining the revised standards of ISO9000~9004 standard series. Some foreign countries implement the standards of FDA certification, and some domestic units have passed the FDA certification.
4. The significance of international certification itself lies not only in strengthening the process control of many quality factors inside the pharmaceutical factory, but also in controlling the key quality factors outside the pharmaceutical factory. Such as formula, raw materials, auxiliary materials, packaging materials, equipment, building materials, etc.
5. The State Administration of Pharmaceutical Products is a GMP certification body representing the country's independent and fair evaluation of drugs, with the code of C 12. Responsible for the priority procurement, recommendation and acceptance of applications for new drugs in international drug trade. As of1June 3, 19981day, the drug supervision and administration department no longer accepted the application for new drug production.
6.GMP certification is a compulsory certification that integrates software, hardware, safety, hygiene and environmental protection. Therefore, it is necessary to establish and operate a scientific and recognized international management system, and invite qualified second parties (consulting institutions) to make overall planning and evaluation with the experts of this enterprise, and formulate quality management manuals and work instructions (including international standards, national standards and industry standards) suitable for this enterprise.
Duties and authorities
1, the State Administration of Pharmaceutical Products 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 "Certification Center of the Bureau of Medicine") undertakes the specific work of drug GMP certification.
2. The drug administrations of provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for the preliminary examination and daily supervision and management of the application materials for drug GMP certification of drug production enterprises in their respective jurisdictions.
Certification application and data review
1. The applicant shall submit an application for drug GMP certification to the local drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government, and submit relevant materials at the same time in accordance with the Administrative Measures for 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.
2, certification application materials accepted by the Bureau of safety supervision department, form review, forwarded to the Bureau of certification center.
3, bureau certification center after receiving the application materials, technical review of the application materials.
4 Bureau certification center shall put forward examination opinions within 20 working days from the date of receiving the application materials, and notify the applicant in writing.
Make on-site inspection plan
1. For the units that have passed the data review, an on-site inspection plan shall be made, and the on-site inspection shall be organized 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.
2. The Certification Center of the Bureau of Medicine is responsible for sending the on-site inspection notice to the inspected unit, and sending a copy to the local provincial drug supervision and administration department, the unit where the inspection team members belong and the safety supervision department of our bureau.
3, the inspection team is generally not more than 3 people, the members of the inspection team must 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.
spot checking
1, the team leader shall be responsible for the on-site inspection.
2. The provincial drug supervision and administration department may send a person responsible for the supervision and administration of drug production as an observer to participate in the on-site inspection of drug GMP certification in this area.
3. The Certification Center of the Bureau of Medicine is responsible for organizing the on-site inspection of GMP certification, and sending personnel to participate according to the situation of the inspected unit, supervising and coordinating the implementation of the inspection plan, and assisting the team leader in drafting the inspection report.
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.
5. The inspection team shall investigate and collect evidence on the inspection items in strict accordance with the inspection plan.
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.
7. The inspection report shall be signed by all members of the inspection team, accompanied by defective items, areas needing improvement, inspectors' records, dissenting opinions and relevant materials.
8. At the last meeting, the inspection team read out the comprehensive evaluation results. The inspected unit may arrange relevant personnel to participate.
9. The inspected unit can 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.
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.
1 1. The inspection team shall make a record of the problems that cannot be identified, 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.
12. the certification center of the audit bureau of the inspection report 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.
Certification and approval
1. After being audited by the Bureau's Safety Supervision Office, it shall be submitted 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.
2. For the pharmaceutical production enterprises (workshops) whose examination and approval results are "qualified", the State Pharmaceutical Products Supervision and Administration will issue the GMP Certificate for Drugs and make an announcement.
Good supply specification
GSP is the abbreviation of English Good Supply Practice, which means good supply specification. It is a set of management procedures to control all factors that may cause quality accidents in the circulation of medical commodities in order to prevent quality accidents. In the whole process of production, management and sales of pharmaceutical commodities, quality problems may occur at any time due to the influence of internal and external factors. Strict measures must be taken in all these links to fundamentally ensure the quality of medical commodities. Therefore, many countries have formulated a series of laws and regulations to ensure the quality of drugs. GLP is implemented in the laboratory stage, GCP is implemented in the clinical stage of new drugs, and GUP and GSP are implemented in the use of medical commodities, which is a very important part of this series of controls.
Quality responsibilities of major functional departments
The system and responsibility of retail enterprises
Institutional responsibility of pharmaceutical wholesale enterprises
GSP certification: analysis of on-site inspection problems
Working procedures for GSP certification on-site inspection
Significance of implementing GSP
How to deal with the deadline of GSP certification for pharmaceutical enterprises
How to promote and implement GSP in pharmaceutical enterprises
Characteristics of current GSP in China
Three connotations of GSP quality management
How to build a streamlined and efficient organization
Three changes that GSP will bring.
Steps to promote GSP implementation
China GSP Certification staff's requirements
GSP certification application materials
Experience of GSP principle in hospital pharmacy management
Notice on GSP certification work
Notice on clarifying the relevant issues of GSP certification
Notice on Implementing GSP Certification