I would like to know about the GMP certification process, what is GMP certification

In the new version of GMP, the functions and responsibilities of practitioners have clear requirements, and the qualifications of the corresponding professionals have also made corresponding requirements, but the reporter learned that only some professionals can have a deeper understanding of GMP, and the quality management and control personnel do not match the scale of production, which has affected the effective operation of the quality system. In addition, the lack of training is also a major constraint to the implementation of the new GMP.

Essence) drug GMP certification process.

1. The applicant shall submit the certification application and application materials to the acceptance hall of the provincial bureau.

2. Copy of "Pharmaceutical Manufacturing Enterprise License" and "Business License" certified by GMP.

3. GMP certified drug production management and quality management self-inspection.

4. Organization chart of GMP certified pharmaceutical manufacturers.

5 GMP certified personnel.

6. GMP certified pharmaceutical manufacturers, production scope, dosage forms and varieties table.

7. GMP certified pharmaceutical production enterprise surrounding environment map, general layout plan, storage floor plan, quality inspection site layout plan (including animal room).

8 GMP certified pharmaceutical production workshop overview and process layout plan.

9. The process flow chart of the type or variety applied for GMP certification, and the main process control points and control items are indicated.

10 Verification of key processes, main equipment, water production system and air purification system of GMP certified pharmaceutical manufacturers (workshops); Inspection instruments, meters, and scales calibration.

11. Calibration of GMP certified inspection instruments, meters, measuring tools and scales.

12 GMP certified pharmaceutical manufacturers (workshops) production management, quality management document catalog.

13 Documents certifying that GMP-certified enterprises meet fire protection and environmental protection requirements.

2. The Provincial Drug Safety Supervision Department will review the form of the application materials (5 working days).

3. The certification center shall conduct a technical review of the application materials (10 working days).

Fourth, the certification center to develop an on-site inspection plan (10 working days).

5. Provincial bureau approval plan (10 working days).

6. The certification center organizes and implements on-site inspection of certification (10 working days).

7. The certification center will conduct a preliminary review of the on-site inspection report (10 working days).

8. The provincial bureau shall examine and approve the preliminary review opinions of the certification (10 working days).

9. Report to the State Bureau for review announcement (10 working days).

The following is the basic process of certification:

1. The applicant shall submit the certification application and application materials to the acceptance hall of the provincial bureau 2. The drug safety supervision department of the provincial bureau shall review the form of the application materials (5 working days) 3. The certification center shall conduct a technical review of the application materials (10 working days) 4. The certification center shall formulate an on-site inspection plan (10 working days) 5. The approval plan of the provincial bureau (10 working days).

6. The certification center organizes and implements the on-site inspection of the certification (10 working days) 7. The certification center conducts a preliminary review of the on-site inspection report (10 working days) 8. The provincial bureau examines and approves the preliminary examination opinions of the certification (10 working days) 9. Report to the national bureau for review announcement (10 working days).

The GMP was developed to minimize contamination and cross-contamination in the production of pharmaceutical productsReducing the occurrence of various errors is an important measure to improve the quality of drugs.

GMP is a set of mandatory standards applicable to pharmaceutical, food and other industries, requiring enterprises to meet the requirements of health and quality in accordance with relevant national laws and regulations in terms of raw materials, personnel, facilities and equipment, production process, packaging and transportation, quality control, etc., and form a set of operable operating specifications to help enterprises improve the sanitary environment of enterprises, find problems in the production process in time, and improve them.

In short, GMP requires pharmaceutical, food and other manufacturers to have good production equipment, reasonable production processes, perfect quality management and strict testing systems to ensure that the quality of final products (including food safety and hygiene) meets the requirements of regulations.

New version of certification. According to Order No. 79 of 2011 signed by the Minister of Health of the People's Republic of China, the Good Manufacturing Practice (2010 Revision) (hereinafter referred to as the new GMP) has been deliberated and approved by the Ministry of Health on October 19, 2010, and will come into force on March 1, 2011.

Compared with the 98th edition, China's new GMP has made considerable progress in terms of management and technical requirements. In particular, high requirements are put forward for the production of sterile preparations and APIs, and the new version of GMP is based on EU GMP, taking into account the domestic gap, and taking the WHO 2003 version as the bottom line.

There are two time nodes for the new GMP certification: the production of sterile drugs such as blood products, vaccines, and injections by drug manufacturers should meet the requirements of the new version of drug GMP before December 31, 2013; The production of other types of drugs should meet the requirements of the new version of the GMP before December 31, 2015. Enterprises (workshops) that do not meet the requirements of the new version of drug GMP shall not continue to produce drugs after the above-mentioned specified period.

The above content refers to: Encyclopedia-GMP certification.

The GMP certification process is as follows:

1. The applicant shall submit the certification application and application materials to the acceptance hall of the provincial bureau;

2. The Provincial Drug Safety Supervision Department will review the form of the application materials (5 working days);

3. The certification center will conduct a technical review of the application materials (10 working days);

4. The certification center formulates an on-site inspection plan (10 working days);

5. Provincial bureau approval plan (10 working days);

6. The certification center organizes and implements on-site inspection of certification (10 working days);

7. The certification center will conduct a preliminary review of the on-site inspection report (10 working days);

8. The provincial bureau will examine and approve the preliminary review opinions of the certification (10 working days);

9. Report to the State Bureau for review announcement (10 working days).

GMP is a set of mandatory standards applicable to pharmaceutical, food and other industries, requiring enterprises to meet the requirements of health and quality in accordance with relevant national laws and regulations in terms of raw materials, personnel, facilities and equipment, production process, packaging and transportation, quality control, etc., and form a set of operable operating specifications to help enterprises improve the sanitary environment of enterprises, find problems in the production process in time, and improve them.

GMP certification is the embodiment of total quality management in the pharmaceutical industry, Article 18 of the Regulations for the Implementation of the Standardization Law of the People's Republic of China stipulates:"National standards and industry standards are divided into mandatory standards and recommended standards"。Pharmaceutical standards, on the other hand, are mandatory.

GMP certification is a set of software, hardware, safety, health, environmental protection in one of the mandatory certification, then it must establish and operate a scientific, recognized international management system;

It is necessary to invite a qualified second party (consulting agency) to gather with the experts of the enterprise to carry out overall planning and evaluation, and formulate a quality management manual and work instruction suitable for the enterprise (including international standards, national standards, and industry standards).