Explanation of "Pharmaceutical Production Quality Management Regulations"
The original Good Manufacturing Practice of "Pharmaceutical Manufacturing Practice" (hereinafter referred to as "Specification") is referred to as GMP. It is the unanimously recognized rule that pharmaceutical companies in the world must follow in the production of drugs, and is a necessary system for pharmaceutical companies to conduct excellent quality management. Its guiding ideology is to use total quality management to ensure the safety, effectiveness, stability, uniformity and quality of drugs, and to ensure that all products meet quality requirements.
One, purpose and meaning
(1) Prevent contamination and quality changes of medicines as much as possible.
(2) Minimize human errors.
(3) Establish a working procedure (quality assurance system) that can guarantee the quality of medicines to the maximum. For this reason, the factories, facilities, equipment, and management necessary for pharmaceutical production must also be considered from these three aspects. The central guiding ideology of GPM is: The quality of any drug is produced, not tested. Therefore, we must emphasize prevention first, establish a quality assurance system in the production process, implement total quality management, and ensure drug quality.
(1) is an effective means to ensure the quality of medicines and a necessary condition for high-quality products.
(2) It is the basis for the government to issue "Pharmaceutical Manufacturing Enterprise License" and "Pharmaceutical Manufacturing Enterprise Certificate" for enterprise quality certification.
(3) Basis for the entry of pharmaceutical products into the international market.
(4) Provide high-quality and trustworthy products for the society and create credibility for the company.
(5) Improve the level of scientific management of enterprises, promote technological progress, improve the quality of personnel, increase economic efficiency, and enhance the competitiveness of enterprises.
Medicines are special commodities that are indispensable for prevention, treatment, rehabilitation and adjustment of the body. The quality of medicines is directly related to the health and life safety of the human body. For this reason, the quality, safety, and effectiveness of pharmaceutical products are affected by countries around the world. The requirements have become more stringent. Although the drug manufacturer inspects the finished product in accordance with the regulations, it is unable to conduct full inspection of the drug. Only a limited sampling inspection is used to determine the quality of the drug. The production process such as contamination, mixing, errors, and It is difficult to prevent it by checking after the fact.
GMP was first formulated by some experts in the United States for quality management in the pharmaceutical industry. At that time, it attracted widespread attention from all over the world. In 1963, the U.S. Congress passed and promulgated it as a law. In 1969, the 22nd World Health Organization (WHO) recommended that all member countries adopt the GMP system. When the 28th World Health Assembly was held in 1977, more than 80 member countries expressed their approval to implement it. So far, more than 100 Several countries and regions have implemented GMP systems, and some countries have subsequently formulated GMP implementation regulations.
With the advancement and development of science and technology, in the field of GMP in recent years, countries have been continuously revising, enriching and improving the implementation of GMP. For example, another important development is the emergence of standards published by the International Organization for Standardization (ISO), and the quality system ISO9000 to 9004 series has been implemented. On the basis of absorbing international experience in promoting GMP, my country’s chemical and pharmaceutical industry organized relevant personnel to draft the "Pharmaceutical Production Management Regulations" in the late 1970s. In 1982, the industry’s "Regulations" (trial version) was formulated. On the basis of extensively soliciting opinions from relevant units across the country, the "Guidelines for the Implementation of Drug Production Management Practices" were compiled and issued together with the "Regulations". In May 1986, the State Administration of Medicine issued a document for full implementation in chemical medicine enterprises. In October 1988, the Ministry of Health issued the "Pharmaceutical Production Quality Management Regulations", which will legally urge pharmaceutical companies to implement the "Regulations". This signifies that my country's pharmaceutical production has entered a new stage of comprehensive scientific management, which will definitely contribute to the development of my country's pharmaceutical industry. Play a positive role in promoting. After nearly 10 years of implementation of the "Specifications" and implementation guidelines, they have absorbed advanced international experience, extensively revised them, and added new content to make them more maneuverable. At the same time, the Ministry of Health "Pharmaceutical Production Quality Management Practices" (1992) Revised version) issued. Its content is also closer to the international level.
3. The basic content of the "Code"
management ⑧ packaging and labeling ⑨ production management and quality management documents ⑩ quality management department (11) self-inspection (12) sales records (13) user opinions and adverse reaction reports (14) attachments, a total of 14 chapters.
The basic content of the "Code" can be summarized as two aspects: hardware (personnel, plant, facilities and equipment) and software (management).
(1) The plant site should be selected in an environment with good natural conditions and no pollution.
(2) The factory building should have sufficient area and space. The equipment, materials, and layout must be equipped with storage areas that can distinguish the raw and auxiliary materials, semi-finished products and finished products before and after inspection.
(3) The plant area shall be arranged according to the divisions of production, public works, administration, and living, and shall not interfere with each other.
(4) The ceiling, walls and floor of the inner surface of the factory building should be smooth and flat, use building materials with a small amount of dust, and be able to withstand cleaning and disinfection.
(5) The factory building shall be clearly divided into clean area, control area and production area according to the dosage form and process requirements of the drug. In the layout, it is necessary to consider setting up purification facilities and rooms suitable for the purification level. For the area of clean facilities such as changing clothes, shoes, washing, buffering, etc., the material entrance should be set separately, and the raw and auxiliary material entrance should be provided with a room for clearing the outer packaging. Materials required for sterility should be treated aseptically.
(6) The plant is reasonably arranged according to the technological process and the required cleanliness level to avoid the mixing of people and logistics. And there should be measures to prevent insects, birds and other animals from entering.
(7) The quality inspection department should have sufficient area. Perfect facilities and clean working environment.
(8) The penicillin production (including sub-assembly) workshop should be strictly separated from other workshops and equipped with a dedicated air conditioning system.
(9) For the equipment used in the production of medicines, the parts in direct contact with the medicines do not work with the medicines, and the transmission parts of the equipment are well sealed to prevent the contamination of materials by lubricants.
(1) All levels of management personnel in pharmaceutical companies, as well as maintenance, production workers, cleaning, storage, transportation, and service personnel related to production activities, should regularly accept the "Code" in accordance with the principles of the "Code" and their respective responsibilities. Training and education, and assessment and filing.
(2) Pharmaceutical companies must be equipped with management personnel at all levels with medical expertise, production experience and organizational capabilities, and a certain number of engineering and technical personnel.
(3) Production workers should conduct regular health checkups and establish health records. Those suffering from infectious diseases and recessive infectious diseases should not participate in the production of direct contact with drugs.
(3) Warehouse Management
(1) The raw and auxiliary materials entering the factory will be checked and accepted by the warehouse staff according to the goods certificate, recorded, and placed in the designated area in the order of entering the factory for inspection, and the raw and auxiliary materials should be filled in and submitted to the quality control department for inspection.
(2) After the qualified raw and auxiliary materials are put into the warehouse, they shall be clearly marked and issued according to the principle of first-in first-out. The records of accounts, objects and cards are consistent. Goods must be stacked away from the wall, the ground, and between the lines of goods.
(3) Packaging materials shall not be stacked in the open air.
(4) Finished products should be put into storage according to the inspection report of the quality control department, and should be placed in batches according to the category. Product sales should be recorded to make it traceable. The sales records should be kept at least until the drug quality responsibility period or one year after the expiration date.
(four) label management
(1) Labels must be stored in special counters classified by varieties, specifications, and batch numbers, and locked and managed by a dedicated person.
(2) For all kinds of drug labels, the materials should be collected and distributed according to the plan, and the variety and quantity should be checked and recorded, and the remaining labels should be destroyed in time by a dedicated person.
(5) Production technology management
(1) All products that are officially produced must formulate process regulations and post technical safety operation laws, and must comply with them. The revision of process regulations generally does not exceed 5 years, and the post operation method does not exceed 2 years.
(2) The input and calculation of the production process should be reviewed by someone, and the operator and reviewer should sign. Check and proofread the measuring container and measuring instrument.
(3) The raw and auxiliary materials, semi-finished products, container, processing line and main equipment used in the production process should be clearly marked.
(4) Before the end of production, the change of varieties and specifications or the change of batch number in each production process, the operation site should be thoroughly cleaned and inspected according to the site clearance requirements, and recorded, and the site clearance certificate will be issued after the quality supervisor has passed the review. Change the lot number or variety.
(5) The original production record is the first-hand original record made in all aspects of the business activities of the enterprise. It is an important source of the most original information and quality information of the enterprise. The original record is filled in by the post operator, and every operator has to complete it. The content is true, the records are timely, complete, clear, and standardized. The input and output of each batch of products are traceable and consistent with related positions, procedures, workshops and phases. Batch production records should be filed according to the batch number and kept until one year after the expiry date of the drug.
(6) The personnel engaged in the production, processing and packaging of pharmaceuticals should strictly abide by the sanitation management system, wear work clothes suitable for the work, and operators who directly contact the pharmaceutical process should not make up or adorn them. The production area should not store non-production items.
(7) Each batch of products shall have complete records of production, monitoring and inspection and batch production records that meet the requirements, and shall be properly kept in accordance with the specified number of years.
(6) Quality Management
(1) Pharmaceutical companies should set up an independent quality supervision department, and be equipped with a certain number of quality inspection and management personnel. The workshop should have a full-time quality supervisor, and the warehouse and production team should have a part-time quality supervisor who is responsible for the raw materials , Quality inspection of finished products, intermediates, packaging materials, labels, etc.
(2) Animals used for inspection should have breeding regulations. Animals for inspection should be marked and recorded, and the animal room should meet the requirements.
(3) The quality supervision department has the right to prevent unqualified raw materials and auxiliary materials from being put into production, unqualified intermediates or semi-finished products flowing into the next process, and unqualified finished products leaving the factory. After engaging in the process, we will change into pre-control, from managing the result to managing the factor.
(4) The quality files and product sample observation system must be established for the officially produced drugs. Good results have been achieved in the implementation of the "Standards." In the next ten years, the implementation of the "Standards" will also have a major qualitative change in the realization of the second-step strategic goal of the national economy. The pharmaceutical industry is a multidisciplinary, high-tech, wide-ranging, and socially compatible department. The in-depth and solid implementation of the "Regulations" is the need to ensure the quality of drugs and the need for scientific management development.
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According to the relevant provisions of the "Environmental Impact Assessment Law" and the "Interim Measures for Public Participation in Environmental Impact Assessment".
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