Are you medicine or food?
GMP is the abbreviation of GoodManufacturingPractice in English, and the Chinese meaning is "Good Manufacturing Practice". It is an independent management system that pays special attention to product quality and health safety in the manufacturing process. It is a set of mandatory standards applicable to pharmaceutical, food and other industries. It requires enterprises to meet health quality requirements in accordance with relevant national regulations in terms of raw materials, personnel, facilities and equipment, production processes, packaging and transportation, quality control, etc., and form an operational set of standards. Operating specifications help companies improve the sanitary environment and promptly identify problems in the production process and improve them.
With the development of GMP, pharmaceutical GMP certification has been implemented internationally. GMP provides basic guidelines for drug production and quality management. Drug production must meet the requirements of GMP, and drug quality must meet legal standards. On July 11, 1995, the Ministry of Health of the People's Republic of my country issued the "Notice on Carrying out the GMP Certification of Drugs" issued by the Ministry of Health and Drug Administration (1995) No. 35. Drug GMP certification is a system for the state to implement GMP supervision and inspection on drug production enterprises (workshops) and drug varieties in accordance with the law and obtain approval. It is an important part of international drug trade and drug supervision and management, and also ensures drug quality stability, safety and Effectiveness is a scientific and advanced management method. In the same year, the china certification committee for drugs (cccd) was established. After the establishment of the State Drug Administration in 1998, the State Drug Administration Drug Certification Management Center was established. Starting from July 1, 1998, the Ministry of Health will not accept applications for the production of new drugs for enterprises that have not obtained drug GMP certification. If a new drug is approved, only a new drug certificate will be issued, but no drug approval number will be issued. Strictly review and approve newly established pharmaceutical manufacturing enterprises. Those who have not obtained a pharmaceutical GMP certification shall not be issued a "Pharmaceutical Manufacturing Enterprise License".
Enterprises (workshops) that have obtained drug GMP certification will give priority to the drug regulatory authorities when applying for the production of new drugs: enterprises (workshops) that have not obtained drug GMP certification as of June 30, 1998 , the drug regulatory authorities will no longer accept applications for new drug production. Drugs that have obtained drug GMP certification certificates can apply to the State Council's drug supervision and administration department for certificates of drug export sales when participating in international drug trade: and can re-apply to the price department for verification of the price of the drug in accordance with national regulations on drug price management. . Drug business units and medical units at all levels must give priority to purchasing and using drugs that have obtained drug GMP certification certificates and drugs produced by enterprises (workshops) that have obtained drug GMP certification certificates. Drugs certified by GMP can use the certification mark on corresponding drug advertising, drug packaging and labels, and instructions.
Food GMP certification was initiated by the United States in the 1960s. Currently, in addition to the United States, which has enacted legislation to enforce food GMP, other countries such as Japan, Canada, Singapore, Germany, Australia, China, etc. still adopt persuasive methods to provide guidance to the industry. Automatic and spontaneous implementation.
Benefits of implementing food GMP certification:
Provides a set of combined standards that must be followed for food production.
Provide the basis for supervision and inspection by the health administration department and food hygiene supervisors.
Provide a basis for establishing international food standards, such as: HACCP, BRC, SQF.
Meet customer requirements and facilitate international trade of food.
Provide important teaching materials for food production and operation personnel to understand the particularities of food production, thereby creating a positive work attitude, stimulating a spirit of high responsibility for food quality, and eliminating good production habits.
Make food production enterprises have stricter requirements for raw materials, excipients, and packaging materials.
It helps food production companies adopt new technologies and new equipment to ensure food quality.
GMP is a management that pays special attention to food hygiene and safety during the production process. GMP requires food production enterprises to have good production equipment, reasonable production processes, perfect quality management and strict testing systems to ensure that the quality of the final product meets the requirements of regulations.
The contents stipulated by GMP are the most basic conditions that food processing enterprises must meet, and are the prerequisites for the development and implementation of other food safety and quality management systems.
Drug GMP certification work procedures
1. Responsibilities and authorities
1.1 The State Food and Drug Administration is responsible for the national drug GMP certification work. The Drug Certification Management Center of the State Drug Administration (hereinafter referred to as the “Bureau Certification Center”) undertakes the specific work of drug GMP certification.
1.2 The drug regulatory authorities of provinces, autonomous regions, and municipalities directly under the Central Government are responsible for the preliminary review and daily supervision and management of drug GMP certification application materials of drug manufacturers in their respective jurisdictions.
2. Certification application and document review
2.1 The applicant must submit the "Drug GMP Certification Application" to the drug regulatory department of the province, autonomous region, or municipality directly under the Central Government, and submit it in accordance with the "Drug GMP Certification Application Form". At the same time, relevant information shall be submitted in accordance with the provisions of the GMP Certification Management Measures. The drug regulatory authorities of provinces, autonomous regions, and municipalities directly under the Central Government shall conduct a preliminary review of the application materials within 20 working days from the date of receipt of the application materials, and submit the preliminary review opinions and application materials to the Safety Supervision Department of the National Medical Products Administration.
2.2 After the certification application materials are accepted and formally reviewed by the Safety Supervision Department of the Bureau, they will be forwarded to the Certification Center of the Bureau.
2.3 After receiving the application materials, the Certification Center of the Bureau will conduct a technical review of the application materials.
2.4 The Certification Center of the Bureau shall provide review opinions within 20 working days from the date of receipt of the application materials and notify the applicant in writing.
3. Develop an on-site inspection plan
3.1 For units that pass the document review, they should formulate an on-site inspection plan and organize an on-site inspection within 20 working days from the date of passing the document review. . The content of the inspection plan should include schedule, inspection items, inspection team members and division of labor, etc. Problems discovered during the data review that require verification should be included in the scope of inspection.
3.2 The Certification Center of the Bureau is responsible for sending the on-site inspection notice to the inspected unit, and sending a copy to the provincial drug regulatory department, the unit where the inspection team members work, and the Safety Supervision Department of the Bureau.
3.3 The inspection team generally does not exceed 3 people, and the members of the inspection team must be drug GMP inspectors of the State Drug Administration. When the inspection team is formed, the inspector should avoid the inspection of drug GMP certification in the jurisdiction.
4. On-site inspection
4.1 The team leader responsibility system shall be implemented for on-site inspection.
4.2 The provincial drug regulatory department may assign a person responsible for drug production supervision and management as an observer to participate in the on-site inspection of drug GMP certification in the jurisdiction.
4.3 The Bureau Certification Center is responsible for organizing GMP certification on-site inspections, and dispatches personnel to participate, supervise, and coordinate the implementation of the inspection plan according to the conditions of the inspected unit, and assist the team leader in drafting inspection reports.
4.4 The content of the first meeting includes: introducing the members of the inspection team; stating inspection precautions; confirming the inspection scope; implementing the inspection schedule; determining the inspection accompanying persons, etc. The person accompanying the inspection 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 entire process of drug production, and be able to accurately answer relevant questions raised by the inspection team.
4.5 The inspection team must strictly follow the inspection plan to investigate and collect evidence on the inspection items.
4.6 Comprehensive assessment The inspection team must assess the defective items found during the inspection in accordance with the inspection and assessment standards, make comprehensive assessment results, and prepare an on-site inspection report. During the assessment and summary period, the inspected unit should avoid the inspection.
4.7 The inspection report must be signed by all members of the inspection team, and must be accompanied by defective items, areas that need improvement, inspector’s records, opinions on objectionable issues, and relevant information.
4.8 The inspection team will read out the comprehensive evaluation results at the next meeting. The unit being inspected can arrange for relevant personnel to participate.
4.9 The inspected unit may put forward different opinions and provide appropriate explanations and explanations on the defective items and assessment results discovered during the inspection. If there is any dispute, it must be verified if necessary.
4.10 The unqualified items found during the inspection and the areas that need to be improved must be signed by all members of the inspection team and the person in charge of the inspected unit, and each party will keep a copy.
4.11 If there are any issues that cannot reach consensus, the inspection team must make a record. After being signed by all members of the inspection team and the person in charge of the inspected unit, each party shall keep a copy.
5. Review of the inspection report
The Certification Center of the Bureau must provide review opinions within 20 working days from the date of receiving the on-site inspection report and related materials submitted by the inspection team. Send it to the Safety Supervision Department of the National Medical Products Administration.
6. Certification and approval
6.1 After review by the Safety Supervision Department of the Bureau, it shall be submitted to the Bureau leadership for approval. The National Medical Products Administration will make a decision on whether to approve it within 20 working days from the date of receipt of the review opinions from the Certification Center of the State Administration.
6.2 For drug manufacturers (workshops) whose approval results are "qualified", the State Food and Drug Administration will issue a "Drug GMP Certificate" and make an announcement.
Drug GMP Certification
1. Regarding drug GMP certification:
The "Drug GMP Certificate" is valid for 5 years. The "Drug GMP Certificate" of a newly established pharmaceutical manufacturing enterprise is valid for one year. Drug manufacturers should re-apply for drug GMP certification 6 months before the expiration date. Newly established pharmaceutical manufacturers must apply for reexamination 3 months before the expiration of the "Drug GMP Certificate". After passing the reexamination, a "Drug GMP Certificate" valid for 5 years will be issued.
2. Information required for GMP certification: < /p>
1. Drug GMP certification application form (in quadruplicate);
2. Copies of "Drug Manufacturing Enterprise License" and "Business License";
3. Drug production management and quality management self-examination status (including company profile and historical evolution, production and quality management status, and correction of defective items in the previous certification);
4. Organization chart of the pharmaceutical manufacturing enterprise (indicate the names of each department, their mutual relationships, and department heads);
5. Resumes of the person in charge and department head of the pharmaceutical production enterprise; registration forms for pharmaceutical and related professional technicians, engineering technicians, and technical workers who have been qualified in accordance with the law, and indicate their departments and positions; senior, middle, and junior technical personnel account for 10% of all employees Proportion table;
6. A list of all dosage forms and varieties within the production scope of the pharmaceutical manufacturer; a list of dosage forms and varieties within the scope of application for certification (indicate the year-round production varieties), including basis standards, drug approval numbers; copies of new drug certificates and production approval documents and other relevant documents;
7. The surrounding environment map of the pharmaceutical production enterprise, the general layout plan, the warehouse layout plan, and the quality inspection site layout plan;
8. Overview of the pharmaceutical production workshop and process layout plan (including changing rooms, washrooms, people and logistics channels, airlocks, etc., and indicating the direction of people and logistics and air cleanliness levels); air supply, return, and exhaust of the air purification system Floor plan; floor plan of process equipment;
9. Apply for the process flow chart of the type or variety to be certified, and indicate the main process control points and control items;
10. Pharmaceutical manufacturers (verification of key processes, main equipment, water production systems and air purification systems in workshops; verification of inspection instruments, meters and scales;
11. Production management of pharmaceutical manufacturers (workshops) , Quality management document directory
3. Drug GMP certification workflow
1. Enterprises applying for certification
2. Safety Supervision Department of the Provincial Food and Drug Administration< /p>
3. Safety Supervision Department of the State Food and Drug Administration
4. Certification Center of the State Food and Drug Administration
5. Safety Supervision Department of the State Food and Drug Administration< /p>