GMP requires that systematic and standardized procedures must be formulated in terms of organization, personnel, plant, facilities and equipment, hygiene, validation, documentation, production management, quality management, product sales and recall, reporting of complaints and adverse reactions, and self-inspection, etc., and that through the implementation of a series of procedures, a ****same purpose can be achieved:
Preventing mixing of different medicines or their ingredients;
Mixing of different medicines or their ingredients;
Compounding of different medicines;
Mixing of different medicines or their ingredients.
Prevention of cross-contamination by other drugs or other substances;
Prevention of errors and distortions in the transmission of measurements and information;
Prevention of accidents in which any raw and testing step is missed;
Prevention of arbitrary operation and non-compliance with standards and low limits of feed and other violations of the rules and regulations;
The main purpose of the development and implementation of GMP is to protect the consumer.
The main purpose of the development and implementation of GMP is to protect the interests of consumers, to ensure that people use drugs safely and effectively; at the same time, it is also to protect drug manufacturers, so that enterprises have a law to follow, rules to follow; in addition, the implementation of GMP is the responsibility of the government and the law given to the pharmaceutical industry, and also China's accession to the WTO after the implementation of the need for quality assurance system of pharmaceuticals ---- because the drug manufacturers do not pass the GMP certification, may be rejected in the international trade of technology and technology, and the implementation of the GMP certification. The GMP is the responsibility of the government and the law to the pharmaceutical industry, and it is also the need to implement the pharmaceutical quality assurance system after China's accession to WTO.
It can be seen that the implementation of GMP is not only a drug manufacturer to the people's drug safety and effective highly responsible spirit of the concrete embodiment of the enterprise is an important symbol of the enterprise, but also an important guarantee of the competitiveness of enterprises and products, and is in line with international standards, so that pharmaceutical products to enter the international market is a prerequisite. Therefore, it can be said that the implementation of GMP standards is the basis for the survival and development of pharmaceutical enterprises, through the GMP certification is the product to the world's "access card".
Some knowledge about GMP certification
Shanghai Zhongmei Squibb Pharmaceutical Company Limited Yuan Songfan
Quality is the lifeblood of the pharmaceutical industry, and the Good Manufacturing Practice (GMP) is the regulations to ensure the quality of drugs, all pharmaceutical companies should follow the provisions of the implementation of GMP.
The basic points of China's GMP include management and technical staffing at all levels; hardware facilities such as plants, workshops, and public works; hardware and management software systems for equipment; hygiene; quality requirements for raw materials, auxiliary materials, packaging materials, and finished products, and storage specifications; production management systems; production management and quality management documentation systems; quality management systems; management and use of packaging materials and labels, product instructions, and so on; and management and use of marketing materials and labels. Management and use of packaging materials and labels, product instructions, etc.; sales records; user opinion handling and adverse reaction reporting system; regular self-inspection and supervision and inspection by health administrative departments.
In recent years, China has implemented a GMP certification system and established the China Drug Certification Committee, which is composed of experts from drug supervision, management, inspection, production, operation, scientific research and use, as stipulated in Article 6 of its charter, and implements GMP certification on behalf of the state.
Certification is currently divided into three types, namely, enterprise certification, workshop certification and product certification. Many companies that are not yet in production are usually certified as enterprises, and after they are formally put into production, they are then certified as products and workshops. Product certification is generally combined with workshop certification, but workshop certification of product quality is not certified, but need to certify the production management and quality management system.
Whether it is enterprise certification, workshop certification and product certification, some of the basic points of GMP can not be ignored, such as plant design and equipment configuration, water, ventilation and air-conditioning systems, warehouse conditions, production management and quality management documentation system, organizational structure.
The first step to certification is to make an application, and the application information includes the factory floor plan, shop floor plan, factory profile, organization, products, and the implementation of GMP in the factory. For the inspection program, you can refer to the China Drug Certification Commission in January 1996, "Drug GMP Certification Inspection Program". For powder injection products, please refer to the June 1996 "Rules for Inspection and Evaluation of the Implementation of Good Manufacturing Practice for Powder Injections" issued by the State Administration of Pharmaceutical Affairs (SAMA). Therefore, the implementation of GMP enterprises, if you can refer to the above documents to prepare better.
The Drug Certification Committee and the Drug Certification Management Center of the Ministry of Health will notify the enterprise to supplement the materials or notify the enterprise not to accept its certification requirements after the preliminary examination. Where the enterprise passes the preliminary examination, the Drug Certification Commission to send an inspection team to carry out inspections, the local drug administration will send observers to participate in the inspection.
Currently, China in the implementation of GMP and certification problems are the following:
(1) Misunderstanding that GMP is the highest standard of quality management of pharmaceutical production. In fact, GMP is the same as the pharmacopoeia standard, belongs to the minimum standard, is legally required to meet the norms.
(2) Many old companies, due to problems in construction, are difficult to meet the requirements of GMP norms through renovation. This is the reason why many foreign companies would rather build new plants than remodel 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, the training of GMP in China has not yet kept up with the international trend. At least one point, very few people in the domestic pharmaceutical industry really know about some of the new guidelines issued by foreign countries in recent years. As a result of this, coupled with the fact that people have different understandings and judgments of GMP, and there are differences in the details, there will be some differences in opinions during the review. Of course, this is very normal, with the certification work, will gradually form a unified understanding and standards.
(4) New multinational companies due to the application of new materials, new equipment, in the impression of the obvious superiority of the old enterprises, the contrast between the larger, and some state-owned enterprises, the gap between the old factory is even greater. This may affect the impression of the certification team.
The author believes that, through the certification, can make the health and drug administration departments, drug production management departments and enterprises are subject to a GMP training, can make everyone's understanding of GMP further. It may be more rewarding and meaningful than going abroad on a walking tour.
With the certification of GMP by the entire pharmaceutical industry and the health and drug administration, I believe that the understanding of GMP by enterprises and higher management will be improved.
During the certification process, special attention should be paid to the following issues:
(1) Preventing cross-contamination, including cross-contamination between different classes of drugs, cross-contamination of human and logistic flows, and cross-contamination between air.
(2) the design of the buffer room is very important, there must be a transition between the different clean areas of the buffer room, and can really play a buffer role.
(3) Poor quality of construction caused by the building details of defects, such as paint, walls, floors, etc..
(4) The cleanliness, hygiene and tidiness of the environment is very much related to the hygiene quality and habits of the people concerned.
(5) The first-in-first-out of products, especially the zero and box processing and the re-sale of returned items.
(6) All documents related to production and quality, as-built drawings and other documents.GMP requirements for documentation: all behaviors are regulated by SOPs; all behaviors are documented; important data should be reviewed and documented; and all records should be filed and kept for inspection and verification.
(7) Human flow and logistics, especially the diversion of human flow and logistics in different clean areas.
(8) different clean areas between the differential pressure display and record is often easy to ignore.
(9) the setting of pools and floor drains and backflow prevention measures (anti-pollution measures).
The implementation of GMP for powder injection workshop was rejected the following 10:
(1) plant, equipment, personnel, production management and quality management of the various scores in one of the less than 70% of the total score.
(2) The head of production and the head of quality are concurrent with each other, or with non-staff personnel.
(3) There is no independent quality inspection department and management, does not have the product quality inspection conditions.
(4) The cleanliness of the plant does not meet the specified requirements.
(5) penicillin-based production plant transfer without residue treatment and trace residue test.
(6) The plant for allergy drugs did not have an independent air-conditioning system to prevent cross-contamination.
(7) The water used for bottle washing did not meet the standard for water for injection.
(8) The dispensing area did not meet class 100 cleanliness requirements.
(9) The conveyor crosses the clean area of different cleanliness levels.
(10) Sterilization steam for disinfection is not clean steam.
In recent years, the adoption of some new technologies, often resulting in confusion about the concept of GMP, such as:
Barrier technology and the application of disposable blowing and irrigation technology, so that the local level 100, while the other for the 100,000 level of cleanliness of the design has become possible.
Computer-controlled high-level shelving, controlled by cargo space, the control of the state is no longer divided into zones. There is no longer a division of the cargo space card, ledger, pending inspection area, qualified area, etc..
Computerized management system, once verified, no longer need to "to be inspected", "qualified" and other labeling instructions, information stored by the computer.
The widespread use of e-mail has led to a significant reduction in paper documents, which are instead stored by computers.
Through the GMP certification activities, we can improve the correct understanding of GMP by participating certified personnel and enterprises, and keep up with the development of the world trend (including the development of new technologies, new equipment, new materials, etc.), so that we can continuously obtain improvement in the implementation of GMP specifications, and also pave the way for the healthy development of our pharmaceutical industry.