GMP certification standards

GMP "is an abbreviation for Good Manufacturing Practice in English, which means" Good Manufacturing Practice "or" Good Manufacturing Standards "in Chinese. It is an autonomous management system that places special emphasis on implementing product quality and hygiene safety in the production process. It is a set of mandatory standards applicable to industries such as pharmaceuticals and food, requiring enterprises to meet hygiene and 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. It forms a set of operable operating norms to help enterprises improve their hygiene environment, timely discover problems in the production process, and make improvements. Simply put, GMP requires food production enterprises to have good production equipment, reasonable production processes, sound quality management, and strict testing systems to ensure that the quality of the final product (including food safety and hygiene) meets regulatory requirements.

Basic principles for drug production and quality management

With the development of GMP, drug GMP certification has been implemented internationally. GMP provides basic guidelines for drug production and quality management. Drug production must comply with GMP requirements, and drug quality must meet legal standards. On July 11, 1995, the Ministry of Health of our country issued the Notice on Carrying out GMP Certification for Drugs (1995) No. 35. GMP certification for drugs is a system in which the country conducts GMP supervision and inspection on drug production enterprises (workshops) and drug varieties in accordance with the law, and obtains recognition. It is an important part of international drug trade and drug supervision and management, and also a scientific and advanced management tool to ensure the stability, safety, and effectiveness of drug quality. In the same year, the China Certification Committee for Drugs (CCCD) was established. After the establishment of the National Medical Products Administration in 1998, the Drug Certification Management Center of the National Medical Products Administration was established. Since July 1, 1998, enterprises that have not obtained GMP certification for drugs will not be accepted by the Ministry of Health for the production of new drugs; For those who approve new drugs, only a new drug certificate will be issued, and no drug approval number will be issued. Strictly approve the establishment of new drug production enterprises, and those who have not obtained the GMP certification certificate for drugs shall not be issued a "Drug Production Enterprise License".

Enterprises (workshops) that have obtained GMP certification for drugs will be given priority by the drug supervision and management department when applying for the production of new drugs. Enterprises (workshops) that have not obtained GMP certification for drugs as of June 30, 1998 will no longer be accepted by the drug supervision and management department for the production of new drugs. Drugs that have obtained GMP certification can apply for a certificate of export sales from the State Council's drug regulatory department when participating in international drug trade, and can reapply to the price department for re evaluation of the drug price in accordance with relevant national regulations on drug price management. Pharmaceutical business units and medical institutions at all levels should give priority to purchasing and using drugs that have obtained GMP certification certificates, as well as drugs produced by enterprises (workshops) that have obtained GMP certification certificates. Drugs certified by GMP can use the certification mark on corresponding drug advertisements, drug packaging and labels, and instructions.

The food GMP certification was initiated by the United States in the 1960s. Currently, except for the United States which has legislated to enforce food GMP, other countries such as Japan, Canada, Singapore, Germany, Australia, and China are still using persuasion methods to guide operators to voluntarily implement it.

The benefits of GMP certification

Provide a set of mandatory combination standards for food production.

Provide a basis for supervision and inspection for health administrative departments and food hygiene supervisors.

To provide a foundation for establishing international food standards, such as HACCP, BRC, SQF.

Satisfy customer requirements and facilitate international trade of food.

To provide important teaching materials for food production and operation personnel to understand the particularity of food production, thereby promoting a positive work attitude, inspiring a spirit of high responsibility for food quality, and eliminating bad habits in production.

Make food production enterprises have stricter requirements for raw materials, auxiliary materials, and packaging materials.

It helps food production enterprises adopt new technologies and equipment to ensure food quality.

GMP is a management approach that places special emphasis on food hygiene and safety during the production process. GMP requires food production enterprises to have good production equipment, reasonable production processes, sound quality management, and strict testing systems to ensure that the quality of the final product meets regulatory requirements. The content stipulated by GMP is the most basic condition that food processing enterprises must meet, and it is a prerequisite for the development and implementation of other food safety and quality management systems.

Work Procedure for Drug GMP Certification

1. Responsibilities and Authorities

1.1 The National Medical Products Administration is responsible for the national drug GMP certification work. The Drug Certification Management Center of the National Medical Products Administration (hereinafter referred to as the "Certification Center") undertakes the specific work of drug GMP certification.

1.2 The drug supervision and administration bureaus of provinces, autonomous regions, and municipalities directly under the central government are responsible for the initial review and daily supervision and management of the application materials for drug GMP certification of drug production enterprises in their jurisdiction.

2. Certification application and data review

2.1 The applying unit shall submit the "Application for Drug GMP Certification" to the drug supervision and administration department of the province, autonomous region, or municipality directly under the central government, and submit relevant materials in accordance with the provisions of the "Management Measures for Drug GMP Certification". 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, and submit the preliminary review opinions and application materials to the Safety Supervision Department of the State Drug Administration.

2.2 After the certification application materials are accepted and formally reviewed by the Safety Supervision Department of the bureau, they will be transferred to the certification center of the bureau.

2.3 After receiving the application materials, the certification center of the bureau shall 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 receiving the application materials and notify the applying unit in writing.

3. Develop on-site inspection plan

3.1 For units that have passed the data review, an on-site inspection plan should be developed and an on-site inspection should be organized within 20 working days from the date of data review approval. The content of the inspection plan should include schedule, inspection items, inspection team members, and division of labor. Any issues discovered and requiring verification during data review 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 copying it to the provincial drug supervision and management department, the unit where the inspection team members are located, 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 GMP inspectors from the National Medical Products Administration. During the composition of the inspection team, inspectors should avoid conducting GMP certification inspections for drugs in their jurisdiction.

4. On site inspection

4.1 On site inspection shall implement a team leader responsibility system.

4.2 Provincial drug regulatory authorities may select a person responsible for drug production supervision and management as an observer to participate in on-site inspections of drug GMP certification in their jurisdiction.

4.3 The Certification Center of the Bureau is responsible for organizing on-site inspections of GMP certification, and sending personnel to participate, supervise, and coordinate the implementation of inspection plans based on the situation of the inspected units, assisting the team leader in drafting inspection reports.

4.4 The content of the first meeting includes: introducing the members of the inspection team; Declaration of inspection precautions; Confirm the scope of inspection; Implement the inspection schedule; Determine the accompanying personnel for inspection. The accompanying personnel for inspection must be the person in charge of the enterprise or the head of the production and quality management department, familiar with the entire process of drug production, and able to accurately answer the relevant questions raised by the inspection team.

The inspection team must strictly follow the inspection plan to investigate and collect evidence on the inspection items.

4.6 The comprehensive evaluation inspection team shall evaluate the defect items found during the inspection according to the inspection evaluation standards, make a comprehensive evaluation result, and prepare a report on the on-site inspection. During the evaluation and summary period, the inspected unit should avoid.

4.7 The inspection report must be signed by all members of the inspection team, and attached with defect items, areas that need improvement, inspector records, opinions on objections, and relevant materials.

4.8 The inspection team did not present the comprehensive evaluation results at the meeting. The inspected unit may arrange for relevant personnel to participate.

4.9 The inspected unit may raise different opinions and provide appropriate explanations and clarifications regarding the defect items and evaluation results discovered during the inspection. If there is a controversial issue, it must be verified if necessary.

Any non-conforming items found during the 4.10 inspection and any areas that need improvement 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.

4.11 If there are any issues on which consensus cannot be reached, the inspection team shall make a record, which shall be signed by all members of the inspection team and the person in charge of the inspected unit, and each party shall hold one copy.

5. Review of inspection reports

The certification center of the bureau shall provide audit opinions and submit them to the Safety Supervision Department of the National Medical Products Administration within 20 working days from the date of receiving the on-site inspection report and relevant materials submitted by the inspection team.

Certification approval

After being reviewed by the Safety Supervision Department of the bureau, it shall be submitted to the bureau leadership for approval. The National Medical Products Administration shall make a decision on whether to approve within 20 working days from the date of receiving the audit opinion from the certification center.

2. For drug production enterprises (workshops) with approval results of "qualified", the National Medical Products Administration shall issue a "Drug GMP Certificate" and make it public.

Drug GMP certification

The validity period of the Drug GMP Certificate is 5 years. The validity period of the "Drug GMP Certificate" for newly established pharmaceutical production enterprises is one year. Drug manufacturers should reapply for drug GMP certification 6 months before the expiration date. Newly established pharmaceutical production enterprises shall apply for a re examination of their Drug GMP Certificate three months before its expiration date. After passing the re examination, a Drug GMP Certificate with a validity period of five years shall be issued.

GMP certification documents

Requirements for Application Materials for Drug GMP Certification

1. Overall situation of the enterprise

1.1 Enterprise Information

◆ Enterprise name and registered address;

◆ Production address and postal code of the enterprise;

Contact person, fax number, and phone number (including 24-hour contact person and phone number for serious drug harm or recall incidents).

1.2 Drug production situation of the enterprise

◆ Briefly describe the production activities approved by the (food) drug supervision and management department of the enterprise, including import sub packaging, export, and information on drugs that have obtained foreign licenses;

◆ Business license, drug production license, and copies of relevant certification documents issued by overseas institutions are required for exports;

All varieties that have obtained approval numbers (can be filled in by different factory addresses, and indicate whether they are produced year-round, with a list of production in the past three years as an attachment);

Whether the production address handles highly toxic, sex hormone drugs and other highly active and allergenic materials, if so, it should be listed and labeled in the attachment.

1.3 Scope of this GMP certification application for drugs

List the production lines, dosage forms, varieties, and copies of registration approval documents for the relevant products applying for GMP certification this time;

The latest inspection conducted by the (food) drug supervision and management department on the production line (including inspection date, inspection results, defects and rectification status, and relevant drug GMP certificates attached). If the production line has undergone overseas drug GMP inspection, its inspection status must be provided together.

1.4 Major changes since the last drug GMP certification

Briefly describe the changes in key personnel, equipment and facilities, and varieties since the last certification inspection.

2. Quality Management System of Enterprises

2.1 Description of Enterprise Quality Management System

The relevant management responsibilities of the quality management system, including the responsibilities of senior management, quality management leader, quality authorized person, and quality assurance department;

Briefly describe the elements of the quality management system, such as organizational structure, main procedures, processes, etc.

2.2 Finished product release procedure

Overall description of the release procedure and basic information (qualifications, etc.) of the personnel responsible for release.

2.3 Supplier Management and Commissioned Production and Inspection

Overview of the requirements for supplier management and the quality risk management methods used in evaluation and assessment;

Briefly describe the situation of commissioned production; (If any)

Briefly describe the situation of entrusted inspection. (If any)

2.4 Quality Risk Management Measures for Enterprises

Briefly describe the quality risk management policy of the enterprise;

The scope and focus of quality risk management activities, as well as the process of risk identification, evaluation, control, communication, and review within the quality risk management system.

2.5 Annual Product Quality Review and Analysis

The situation and focus of the annual product quality review and analysis conducted by the enterprise.

3 personnel

3.1 Organizational charts including quality assurance, production, and quality control (including senior management), as well as organizational charts of the respective quality assurance, production, and quality control departments;

3.2 Qualifications of key personnel in the enterprise and key technical personnel engaged in quality assurance, production, and quality control;

3.3 The number of employees in various departments including quality assurance, production, quality control, storage, and shipping.

4 Factory buildings, facilities, and equipment

4.1 Factory Building

Briefly describe the construction and usage time, type (including structure and materials of interior and exterior surfaces), and area of the building site;

The overall layout plan of the factory area, the layout plan and flow diagram of the production area, indicating the scale. The cleanliness level of the room, the pressure difference between adjacent rooms, and the indication of the production activities carried out in the room should be marked;

Briefly describe the layout of all production lines within the scope of certification application;

Provide a brief description of the warehouse, storage area, and special storage conditions.

4.1.1 Brief description of air conditioning purification system

The working principle, design standards, and operating conditions of air conditioning purification systems, such as intake air, temperature, humidity, pressure difference, air exchange rate, return air utilization rate, etc.

4.1.2 Brief description of water system

The working principle, design standards, operation status, and schematic diagram of the water system.

4.1.3 Brief description of other public facilities

The working principle, design standards, and operating conditions of other public facilities such as compressed air and nitrogen.

4.2 Equipment

4.2.1 List the main instruments and equipment used for production and inspection.

4.2.2 Cleaning and Disinfection

Describe the methods and verification of cleaning, disinfecting, and using equipment surfaces in direct contact with drugs.

4.2.3 Key computerized systems related to drug production quality

Describe the design and validation of key computerized systems related to drug production quality.

5 files

Describe the file system of the enterprise;

Briefly describe the drafting, revision, approval, distribution, control, and archiving system of the document.

6 Production

6.1 Product Production Status

Overview of the products produced (brief description);

The process flow chart of the dosage form and variety applied for certification this time, and indicate the main quality control points and projects.

6.2 Process Validation

Briefly describe the principles and overall situation of process validation;

Briefly describe the principles of rework and reprocessing.

6.3 Material Management and Warehousing

Processing of raw materials, packaging materials, semi-finished products, and finished products, such as sampling, waiting for inspection, release, and storage;

Handling of non-conforming materials and products.

7 Quality Control

Describe all activities carried out by the enterprise quality control laboratory, including inspection standards, methods, validation, etc.

8 Shipping, Complaints, and Recalls

8.1 Shipping

Briefly describe the controls required for the product during transportation, such as temperature/humidity control;

◆ Methods to ensure product traceability.

8.2 Complaints and recalls

Briefly describe the procedures for handling complaints and recalls.

9 Self check

Briefly describe the self inspection system, with a focus on the area selection criteria in the planned inspection, the implementation and rectification of self inspection.

Drug GMP certification process

1. The declaring enterprise shall submit the certification application and application materials to the provincial bureau acceptance hall

2. Provincial Drug Safety Supervision Department conducts formal review of application materials (5 working days)

3. Certification center conducts technical review of application materials (10 working days)

4. Certification center develops on-site inspection plan (10 working days)

5. Provincial approval plan (10 working days)

6. Certification Center organizes on-site certification inspection (10 working days)

7. Certification center conducts preliminary review of on-site inspection report (10 working days)

8. Provincial Bureau approves the initial review opinions on certification (10 working days)

9. Report to the National Bureau for release of review notice (10 working days)

Drug GMP Certification Standards

The GMP standard (Good Manufacturing Practice) is a system designed to ensure the continuous production of drugs under specified quality standards. It is established to minimize the risk of non-compliance in the drug production process. GMP includes requirements in all aspects, from factory buildings to floors, equipment, personnel and training, hygiene, purification of air and water, production, and documentation. GMP "is an abbreviation for Good Manufacturing Practice in English, which means" Good Manufacturing Practice "or" Good Manufacturing Standards "in Chinese. It is an autonomous management system that places special emphasis on implementing product quality and hygiene safety in the production process. It is a set of mandatory standards applicable to industries such as pharmaceuticals and food, requiring enterprises to meet hygiene and 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. It forms a set of operable operating norms to help enterprises improve their hygiene environment, timely discover problems in the production process, and make improvements. Simply put, GMP requires production enterprises to have good production equipment, reasonable production processes, sound quality management, and strict testing systems to ensure that the quality of the final product (including food safety and hygiene) meets regulatory requirements.

The content stipulated by GMP is the most basic condition that food processing enterprises must meet.

Good Manufacturing Practice (GMP) is a regulation that guides drug production and quality management. The World Health Organization officially announced the GMP standards in November 1975. The concept of drugs internationally includes veterinary drugs, and only a few countries such as China and Australia separate human drug GMP and veterinary drug GMP.