Analysis:
Introduction of GMP standard
GMP is the abbreviation of the English word Good Manufacturing Practices. It was originally written by six professors from Temple University in the United States, and was promulgated by law in developed countries in Europe and America in the 1960s and 1970s, requiring pharmaceutical companies to adopt it widely. GMP standard has been revised twice in 1992 and 1998 since it was officially promoted in China.
GMP requires that systematic and standardized procedures must be formulated in terms of institutions, personnel, factories, facilities and equipment, hygiene, verification, documentation, production management, quality management, product sales and recycling, complaints and adverse reaction reports, and self-inspection. By implementing this series of procedures, the same purpose can be achieved:
Prevent the mixing of different drugs or their components;
Prevent cross-contamination caused by other drugs or other substances;
Prevent errors and distortions in measurement transmission and information transmission;
Prevent accidents that omit any hygiene and inspection steps;
Prevent the occurrence of illegal accidents such as arbitrary operation and non-implementation of standards and low-limit feeding;
The main purpose of formulating and implementing GMP is to protect the interests of consumers and ensure people to use drugs safely and effectively; At the same time, it is also to protect pharmaceutical production enterprises and make them have laws to follow and rules to follow; In addition, the implementation of GMP is the responsibility entrusted to the pharmaceutical industry by * * * and the law, and it is also the need to implement the drug quality assurance system after China's accession to the WTO-because pharmaceutical manufacturers may be rejected from the technical barriers of international trade if they fail to pass GMP certification.
It can be seen that the implementation of GMP is not only a concrete manifestation of the highly responsible spirit of pharmaceutical production enterprises for people's drug safety, but also an important symbol of enterprises, an important guarantee for the competitiveness of enterprises and products, and a prerequisite for pharmaceutical products to enter the international market in line with international standards. Therefore, it can be said that the implementation of GMP standards is the basis for the survival and development of pharmaceutical manufacturers, and GMP certification is the "access certificate" for products to go global.
Some understandings of GMP certification
Yuan Songfan of Shanghai Sino-American Squibb Pharmaceutical Co., Ltd.
Quality is the lifeline of the pharmaceutical industry, and good manufacturing practice (GMP) is the law to ensure the quality of drugs, and all pharmaceutical enterprises should follow GMP.
The basic points of GMP standards in China include the allocation of managers and technicians at all levels; Hardware facilities such as factories, workshops and public works; Equipment hardware and management software system; Hygiene; Quality requirements and storage specifications of raw and auxiliary materials, packaging materials and finished products; Production management system; Production management and quality management file system; Quality management system; Management and use of packaging materials, labels and product manuals; Sales records; User opinion handling and adverse reaction reporting system; The administrative department of health conducts regular self-examination and supervision and inspection.
In recent years, China has implemented the GMP certification system, and established the China Drug Certification Committee composed of experts in drug supervision, management, inspection, production, management, scientific research and use to carry out GMP certification on behalf of the country.
At present, there are three kinds of certification, namely enterprise certification, workshop certification and product certification. Many enterprises that have not put into production generally carry out enterprise certification, and then carry out product certification and workshop certification after formal production. Product certification is generally combined with workshop certification, but workshop certification does not certify product quality, but requires certification of production management and quality management system.
Whether it is enterprise certification, workshop certification or product certification, some basic points of GMP can not be ignored, such as plant design and equipment configuration, water, ventilation and air conditioning system, warehouse conditions, production management and quality management document system, organizational structure and so on.
Certification must be applied first, and the application materials include factory floor plan, workshop floor plan, factory introduction, organization, products and GMP implementation in the factory. See GMP Certification Inspection Item of China Drug Certification Committee 1996 1 for inspection items. For injection products, please refer to the Detailed Rules for Inspection and Evaluation of Good Manufacturing Practices for Injection issued by the State Administration of Medicine in June 1996. Therefore, it is best for enterprises to refer to the above documents when implementing GMP.
After passing the preliminary examination, the Drug Certification Committee and the Drug Certification Management Center of the Ministry of Health will inform the enterprise to supplement the materials or inform the enterprise not to accept its certification requirements. After the enterprise has passed the preliminary examination, the Drug Approval Committee will send an inspection team to conduct the inspection, and the local drug supervision department will send observers to participate in the inspection.
At present, there are the following problems in GMP implementation and certification in China:
(1) It is a misunderstanding that GMP is the highest standard for quality management of pharmaceutical production. In fact, GMP, like the Pharmacopoeia standard, belongs to the minimum standard and is a legal norm that must be achieved.
(2) Many old enterprises, due to problems in construction, are difficult to meet GMP requirements through transformation. This is why many foreign companies prefer to build new factories rather than transform old ones.
(3)GMP itself has a development process. Due to the development of new products, new materials and new processes, the content of GMP itself is also developing. However, GMP training in China has not kept up with the international trend. At least, few people in the domestic pharmaceutical industry really understand some new guidelines issued abroad in recent years. Because of this, and everyone's different understanding and judgment on GMP, there are differences in details, so there will be some different views when judging. Of course, this is normal. With the development of certification, it will gradually form a unified understanding and standard.
(4) Due to the application of new materials and new equipment, the newly-built multinational companies are obviously better than the old enterprises in impression, and have a great contrast with some old state-owned enterprises. This may affect the impression of the certification team.
The author believes that through certification, health and drug supervision departments, drug production management departments and enterprises can receive GMP training, which can make everyone know more about GMP. Compared with a cursory inspection abroad, it may be more rewarding and meaningful.
With the certification of GMP by the whole medical field and the health and drug supervision department, it is believed that the understanding of GMP by enterprises and superior management departments will be improved.
In the process of certification, special attention should be paid to the following issues:
(1) Prevent cross-contamination, including cross-contamination between different kinds of drugs, cross-contamination between people and logistics, cross-contamination between air, etc.
(2) The design of buffer room is very important. There should be transitional buffer rooms between different clean areas, which can really play a buffering role.
(3) Defects in details of buildings caused by poor construction quality, such as paint, walls and floors.
(4) The cleanliness of the environment is closely related to the health quality and habits of relevant personnel.
(5) FIFO products, especially piecemeal merger and return and resale.
(6) All documents related to production and quality, as-built drawings and other documents. GMP requirements for documents: all actions have SOP specifications; All actions are recorded; Important data should be checked and recorded; All records should be filed for inspection and verification.
(7) People flow and logistics, especially the diversion of people flow and logistics in different clean areas.
(8) The display and recording of pressure difference between different clean areas are often neglected.
(9) Setting of pools and floor drains and backflow prevention measures (pollution prevention measures).
The following items 10 were rejected due to GMP implementation in the injection workshop:
(1) The score of one item of plant, equipment, personnel, production management and quality management is less than 70%.
(2) The person in charge of production and the person in charge of quality should be combined with each other or use supernumerary personnel.
(3) There is no independent quality inspection department and management department, and product quality inspection conditions are not available.
(4) The cleanliness of the workshop can not meet the specified requirements.
(5) When the penicillin production workshop was switched to production, residue treatment and trace residue detection were not carried out.
(6) Allergy pharmaceutical factory has no independent air conditioning system, which can't prevent cross-contamination.
(7) The water used for bottle washing does not meet the standard of water for injection.
(8) The repackaging area does not meet the cleanliness requirements of 100.
(9) The conveying tool passes through clean areas with different cleanliness.
(10) There is no clean steam in the sterilization steam for disinfection.
In recent years, the adoption of some new technologies often leads to confusion of GMP concepts, such as:
The application of barrier technology and one-time blowing irrigation technology makes it possible to design some parts with 100 grade and some parts with 100 grade cleanliness.
Computer-controlled high-rise shelves are controlled by position, and the state control is no longer divided by region, but by computer. No longer divide goods location cards, ledgers, areas to be inspected and qualified areas.
Once the computer management system is verified, there is no need for labels such as "pending inspection" and "qualified", and the information is stored by the computer.
With the widespread use of e-mail, paper documents are greatly reduced, but stored by computers.
Through GMP certification activities, we can improve our correct understanding of GMP by participating in Certification staff and enterprises, keep up with the development of world trends (including the development of new technologies, new equipment and new materials), make us constantly improve in the process of implementing GMP norms, and pave the way for the healthy development of China's pharmaceutical industry.
See bsy.nease/gmp/gmp-renzheng for more GMP related information.