A purpose and significance
Drug manufacturers must strictly implement the drug GMP, and effectively fulfill the main responsibility for the quality of drugs. The legal representative of the pharmaceutical production enterprises must be responsible for the quality of the drug, the person in charge of production, quality authorized person responsible for the quality of the drug. Ensure that the rules and regulations of drug production management and quality management are fully implemented. Through tracking and inspection, so that the drug production enterprises of the legal awareness, sense of responsibility, quality awareness has been generally improved, and promote the strict implementation of pharmaceutical production quality management standards, the full implementation of quality management responsibilities. At the same time, to further strengthen the regulatory authorities at all levels to strengthen the supervision of drug production responsibilities, improve the level of supervision in accordance with the law, and severely investigate and deal with violations of the law, to ensure the quality and safety of medicines.Two, the scope and content of the inspection
(a) the scope of the inspection: our province has been through the "Good Manufacturing Practice" (revised in 2010) certification of drug production enterprises (including part of the production line), including high-risk drug production enterprises in the province, other preparations and the production of raw materials, Chinese medicine, Chinese medicine, Chinese medicine, Chinese medicine, Chinese medicine, Chinese medicine, Chinese medicine, Chinese medicine, Chinese medicine, Chinese medicine and Chinese medicine. Raw material drugs, Chinese traditional medicine tablets, medical oxygen production enterprises.
(2) check the key links and content:
1, GMP certification of unqualified items of the rectification situation; 2, the production of essential medicines production enterprises should be combined with the verification of the prescription process to focus on checking the production of essential medicines and quality management; 3, the person in charge of the enterprise, the person in charge of production and quality and quality Authorized person whether there are changes, such as changes in personnel to meet the requirements and requirements for the record; technical staff to meet the requirements of the team, whether stable; staff training; the establishment and implementation of the enterprise quality authorization system, drug manufacturers whether to establish the production, quality management of all aspects of the responsibility system and accountability system, and the implementation of the actual work of the layers. 4, plant, production workshop, laboratory and equipment (focusing on checking the air purification system, process water, the main production and testing equipment) use, maintenance, maintenance; 5, material management: materials should be purchased from suppliers in line with the provisions and relatively fixed, the supplier should be assessed to determine. Supplier assessment, supplier qualification documents, quality management system, purchase contracts and other information should be complete and archived. Drug production materials used in the purchase, inspection, storage, issuance, use, etc. should be developed management system, drug production materials should be in line with the appropriate standards, purchased materials should be strictly implemented acceptance, sampling and testing procedures, and in accordance with the provisions of the warehouse, focusing on checking the supplier's change of circumstances; such as extracts, such as the supplier of the material into the supplier's qualification audit; the procurement of Chinese herbal medicines, supplier audits, inspections, storage, feeding, etc.; and the supplier's qualification audit. Production companies must do into, storage, sales, tickets, accounts, goods in line. 6, production management: drugs should be in accordance with legal standards, production processes and SOP organization of production; verification and re-verification of the situation; material balance, deviation processing and handling of defective products; production equipment to meet the production of all varieties of technological requirements; inspection facilities, equipment to meet the inspection requirements of all varieties of enterprises, commissioned by the test project whether it is in line with the requirements of whether the test is conducted ; the enterprise storage facilities and area to meet the production of all varieties of materials (raw materials, excipients, packages, finished products, etc.) storage requirements, according to the characteristics of the material to develop the appropriate storage, maintenance measures; enterprise GMP management documents can be combined with the characteristics of the varieties of the development, whether it has the relevance and operability, review of the process protocols, job SOP, batch production records and other key documents relevance, Operability, rationality and the actual production process of the coincidence; the actual production positions are specific production varieties of post SOP and batch production records, whether to truly reflect and record the production process of the main control items and technical parameters; each dosage form of at least three production batch size, process complexity, long technical routes, high risk of quality of the focus of varieties, from the purchase of raw and auxiliary materials, the production process, Inspection and other aspects of a comprehensive inspection; 7, commissioned inspection: commissioned inspection behavior, the commissioned unit has the qualifications, commissioned by the party and the commissioned party signed a contract, whether the test is in accordance with the provisions of the commissioned test project, whether the commissioned project in the inspection of the qualified report and all the test project before the organization of the production; 8, commissioned production: commissioned and commissioned to produce, focusing on verifying whether the production procedures; the commissioned production procedures; the commissioned production procedures; the commissioned production procedures; the commissioned production procedures; the commissioned production procedures; the commissioned production procedures; the commissioned production procedures; the commissioned production procedures; the commissioned production procedures; the commissioned production procedures. Commissioned production-related procedures; commissioned party has the ability to accept the commissioned production, whether the commissioned party's pharmaceutical production process organization; commissioned production or commissioned production of pharmaceutical quality control; 9, the use of raw materials, excipients, direct contact with the drug packaging materials are in line with the requirements of medicinal use; 10, drug labeling, instruction manuals with the content of the approval of the drug regulatory authorities, style, text consistent; 11, food and drug supervision and management departments at all levels of enterprises in violation of the "Drug Administration Law", "Drug Manufacturing Supervision and Administration Measures" and other laws and regulations to deal with the opinions or results; 12, in recent years, adverse drug reaction monitoring of high-risk varieties found in the production of quality management; 13, for a variety of reasons to require the closure of the enterprise and part of the production line to focus on.Three, work requirements
The provincial bureau of the relevant units directly under the city (state) Food and Drug Administration (including Gui'an New Area, Renhuai City, Weining County Bureau, the same below) should attach great importance to the "double random, a public" requirements, will have the jurisdiction to check the qualifications of personnel into the inspector pool. Qualified personnel in the area will be included in the inspector pool, randomly select inspectors to form inspection teams, and randomly select the inspected enterprises for inspection. All drug manufacturers should actively cooperate with the tracking and inspection work, and shall not conceal or anonymously report the relevant information when being inspected.1, the strict implementation of tracking inspection program, record the on-site inspection, fill out the "on-site inspection notes" in a timely manner, after the end of the on-site inspection, write "Drug GMP certification tracking inspection report" . Each city (state) bureau should establish drug GMP tracking inspection files.
2, adhere to standards, quality assurance. in the tracking inspection should adhere to strict inspection, the defects found in the project, by the city (state) bureau to supervise enterprises to rectify in place; illegal, illegal behavior should be transferred to the inspection department in a timely manner to investigate and deal with; not in line with the drug GMP inspection and evaluation standards, the city (state) bureau in a timely manner in writing to recommend that the Provincial Bureau of the recovery of its corresponding dosage form of the "Drug GMP certificate.
3, the drug manufacturer did not implement the provisions of the "Good Manufacturing Practice", to order rectification; on the failure to comply with the provisions of the GMP certification, according to law to withdraw the "Drug GMP Certificate"; the circumstances are serious, the revocation of the "Drug Manufacturing License".
4, the situation of the inspection of drug manufacturers and the results of the inspection should be publicized in the local municipal and state websites.
5, to strict discipline, according to law. Supervision and management departments at all levels should be clear supervision and inspection responsibilities, to do not go through the motions, leaving no dead ends, to eliminate all hidden dangers of insecurity. The supervision is not in place, problems or serious consequences, according to the relevant laws and regulations should be held responsible for the supervision department and the relevant personnel.
Inspectors in the inspection should strictly abide by the drug GMP certification inspection discipline, and effectively do according to the law supervision, scientific and fair, clean and efficient, standardized behavior, consciously accept the disciplinary departments and business supervision, establish a good image of the food and drug supervision and management system.Four, check the work arrangements
The provincial bureau is responsible for the province's high-risk drug manufacturers tracking inspection work; other preparations and raw materials, Chinese medicine, tablets, medical oxygen manufacturers of pharmaceutical GMP tracking inspection by the municipal (state) Food and Drug Administration is responsible for. (a) Inspection time:April to November 2017. (ii) inspection mode:1, tracking inspection and daily supervision and inspection combined , can be combined with the focus of daily supervision and inspection together;
2, tracking inspection and strengthening of basic drug production supervision combined , supervision of basic drug manufacturers in accordance with the legal standard The prescription, process, quality standards for the organization of production and testing, timely detection of hidden dangers in the drug production process, strict implementation of the product recall system, in accordance with national requirements for the implementation of supervision, to ensure that the quality and safety of essential medicines.3, tracking and inspection and prescription, process verification work combined, check the enterprise product prescription, process traceability, whether the approved prescription, process organization production;
4, tracking and inspection and supervision and inspection of the problem of rectification of a combination of , checking the enterprise at all levels of food and drug supervision and management department of the rectification of the problem. Food and drug supervision and management departments of the rectification of the problems raised;
Take on-site inspection, each inspection shall not be less than two people. Inspection team to determine the inspection schedule a day in advance to inform the inspection unit, on-site inspection should be carefully filled out "drug production enterprises GMP tracking inspection site inspection report" (in triplicate), site inspection report should be the above 13 key inspection links and content of the special description, while listed in accordance with the GMP evaluation standards for the inspection of the defects found in the description.
Fifth, the summary of the report
The city (state) bureau should be November 15, 2017 will be tracking inspection work summary reported to the provincial bureau of drug and cosmetic production supervision, the summary should include the following: (a) inspection of the overall situation, including the number of enterprises, including inspection, the specific implementation of the steps, inspection methods, etc.; (ii) the main results achieved; (b) the main results; (c) the main results, the main results of the inspection, the main results of the inspection. The main results achieved; (C) the main problems in the production and quality management of enterprises; (D) violations of the law and handling opinions, including the name of the enterprise, violations of the law, the facts, the basis for processing, processing reasons; (E) the inspection team that the supervision of the weak links, including the system, the mechanism, the system, the supervision and inspection methods and methods, the quality of staff and so on; (F) for the existence of problems, the enterprise has taken measures and recommendations for future work, including the establishment of a long-term mechanism to strengthen the supervision of drug production and suggestions.