Medical net on July 4, the food and drug administration of 7 provinces to trace the drug companies, guizhou just released the plan!
On July 3rd, the food and drug administration of guizhou province released the "implementation plan for the implementation of GMP follow-up examination in 2017" (hereinafter referred to as the plan).
And some provinces, guizhou the track inspection scope is larger: anyone who has passed the "drug production quality management norms" (revised in 2010) certification of pharmaceutical production enterprise (including the part of the production line), including guizhou high-risk drug manufacturers and other preparations and active pharmaceutical ingredients, Chinese medicine yinpian, medical oxygen production enterprises, will be to track inspection.
According to guizhou food drug administration website database, including the preparation, raw materials, Chinese medicine yinpian, medical oxygen production enterprises, a total of 152 - guizhou yi hundred, magic of guizhou, guizhou lark, and other enterprises, are well-known in the industry.
The inspection time for this arrangement in guizhou is: from April to November 2017, the focus will be examined in 13 links (see annex).
According to the plan, inspection of drug companies is a combination. Track inspection to combine with the daily supervision and inspection, to strengthen basic drug production supervision, track inspection with the combination of prescription and process verification work -- interlocking, layer upon layer scanning, leave no dead Angle.
It is important to note that guizhou's plan, which was completed on March 24, was made public for the first time on July 3.
Some provinces have made public the inspection of the key, the name of the tracking enterprise and the time period of inspection. But there are also provinces that have only posted messages on their official websites, without revealing much information. Here are some of the values that may be relevant to the business:
On June 14, the first batch of drug GMP tracking and inspection work in heilongjiang province was held at the provincial food and drug audit center. Random extraction of the drug GMP certificate in 2015. The sampling inspector 28, the field inspection group 9, the inspection enterprise 18.
On March 13, 2017, hunan food and drug administration issued the 2017 drug GMP tracking and inspection plan.
Will adopt the way of "double random", there are some quality risk potential for the 20 enterprises implement track inspection, key check in last year's supervision to sample unqualified varieties more, sent a warning letter, a new start and new varieties listed has reached the age of three years.
On January 25, 2017, the food and drug administration of shanxi issued a notice on carrying out the 2017 drug GMP tracking inspection. The list of 25 drug manufacturers was determined by means of random lottery. This year's drug GMP tracking should be completed by the end of October, and submit the work summary before November 20th.
On April 14, guangxi launched the 2017 drug GMP follow-up inspection. To extract a certain number of certified enterprises, establish a tracking and inspection enterprise library, and randomly extract the inspection objects; Implementation of "no notification, no greeting, no report, no accompanying reception, straight to the base, direct site" inspection mode.
On March 8, 2017, shandong food and drug administration announced a follow-up inspection plan. In 2017, the provincial bureau plans to carry out a follow-up inspection of 50 times, focusing on enterprises with high risk and risk potential problems.
The city keeps track of it. Cities based on ShengJu tracking check, combining the reality of jurisdiction, as a whole the jurisdiction track inspection plan, track inspection unit and ShengJu sure scheme in principle is not coincidence, but the city bureau think that have a higher risk, also can overlap.
In January 2017, the anhui province food drug administration announced in 2017 drug GMP tracking flight inspection scheme, every 2016 complain inform against quality safety problems of unqualified, sampling frequency of more varieties, and are classified as high risk level of backwardness, drug GMP certification examination "warning letter" and defect project more pharmaceutical production enterprise, is listed as one of the key check this year.
Attached: GMP tracking and implementation plan of drug production enterprise in guizhou in 2017
Various cities, state food and drug administration, guian new district, renhuai city, weining county market supervision and administration bureau:
In order to further strengthen the supervision of pharmaceutical production enterprises in the province, the provincial bureau has formulated the implementation plan for GMP tracking and inspection of drug production enterprises in 2017, and it is issued to you, please follow the implementation.
Guizhou food and drug administration
March 24, 2017
Is drug GMP pharmaceutical production and the basic principles of quality management, strictly in accordance with the implementation of GMP is the important measures to strengthen the supervision and administration of pharmaceutical production enterprise, is the effective means to ensure the quality of medicines. According to the regulations on the management of drug production quality management, according to the actual situation of drug production supervision in our province, this implementation plan is formulated in accordance with the principle of "double random disclosure".
purpose
Drug production enterprises must strictly implement drug GMP and fulfill the responsibility of drug quality. The legal representative of the pharmaceutical production enterprise must be responsible for the quality of the drug, and the responsible person shall be responsible for the quality of the drug. To ensure that all rules and regulations governing drug production management and quality management are fully implemented. By tracking check, make the pharmaceutical production enterprise legal consciousness, responsibility consciousness, quality consciousness is generally improved, promote enterprise strict drug production quality management standard, the full implementation of quality management responsibility. At the same time, we will further strengthen the supervisory departments at all levels to strengthen the supervision and responsibility of drug production, raise the level of supervision in accordance with the law, crack down on illegal and illegal ACTS, and ensure the quality and safety of medicines.
Ii. Scope and contents of inspection
(a) scope of inspection: our province has passed the "drug production quality management norms" (revised in 2010) certification of the pharmaceutical production enterprise (including the part of the production line), including the high-risk drug manufacturing enterprises in our province, other preparations and active pharmaceutical ingredients, Chinese medicine yinpian, medical oxygen production enterprise.
(ii) inspection of key links and contents:
1. The rectification of GMP certification unqualified projects;
2. The production enterprises of basic drugs should check the production and quality management of basic drugs with the focus of the prescription process verification;
3. Whether there is any change in the responsible person, production and quality of the company and the quality authorizer, if there are any changes in the compliance of the requirements and the filing of the requirements; Whether the technical team meets the requirements and is stable; Staff training; Enterprise quality system authorized people establish and execution, whether the pharmaceutical producing enterprises to establish each link of production, quality management responsibility system and responsibility system, layer upon layer in the practical work and implement.
The use, maintenance and maintenance of factories, workshops, laboratories and equipment (emphasis on air purification system, process water, main production and inspection equipment);
5. Material management: the material shall be purchased and fixed by the suppliers who meet the requirements, and the supplier shall be determined by evaluation. Information on supplier assessment, supplier qualification document, quality management system, purchase contract and other information shall be complete and archived. Used in pharmaceutical production material purchase, inspection, storage, distribution, use, and other management system should be established, pharmaceutical production material should comply with the corresponding standard, the purchase of material used should strictly carry out inspection, sampling inspection procedure, and in accordance with the provisions, warehousing, focusing on the situation of suppliers; If there is a supplier qualification audit of the extract, Procurement, supplier audit, inspection, storage, feeding, etc. Production enterprises must achieve, save, sell, ticket, account and goods.
6. Production management: the drug should be produced according to legal standard, production process and SOP organization; Verification and revalidation; Material balance, deviation treatment and non-conforming product processing; Whether the production equipment of the enterprise can meet the technological requirements of all the production varieties; Whether the inspection facilities and equipment of enterprises can meet the inspection requirements of all varieties, whether the inspection items entrusted are in conformity with the requirements and whether they have been tested; Storage facilities of the enterprise and the area can meet the production of all known varieties of materials (raw materials, auxiliary materials, packaging materials and finished products, etc.) of the storage requirements, whether according to characteristics of materials storage and maintenance measures; GMP management files can be combined with characteristics of varieties, whether with pertinence and maneuverability, review procedure, post the SOP, batch production records and other key documents of pertinence, feasibility, rationality and the actual production process experimental data; Whether the actual production post has the SOP and batch production record of specific production varieties, whether it can truly reflect and record the main control items and technical parameters in the production process; Each dosage forms to choose at least three production batch, long process complex, technical route, the focus of the quality risk varieties, from raw material purchase, production process and test conditions to conduct a comprehensive inspection;
7, entrusted inspection: have entrusted inspection behavior, entrusted units have qualification, whether the entrusting party and the entrusted party to sign the contract, whether the inspection by the regulation, whether have entrusted inspection all qualified report and the project project after qualified to organize production;
8. Commissioned production: commissioned production and commissioned production, mainly check whether there are related procedures for the production of commissioned production; Whether the trustee has the ability to accept the production of the entrusted production and whether the entrusted party has the ability to produce the products according to the production process of the drug production of the client; Entrusted production or entrusted production of drug quality monitoring;
9. Whether the packaging materials used for raw materials, auxiliary materials and direct contact drugs meet the medical requirements;
10. Whether the label of the drug and the instructions are consistent with the content, style and text approved by the pharmaceutical supervisory and administrative department;
11. The supervision and administration departments of food and drug administration at all levels shall deal with the opinions or results of enterprises in violation of the drug administration law, the measures for the supervision and administration of drug production and their laws and regulations;
12. In recent years, the production quality management of high-risk varieties detected in drug adverse reaction monitoring;
13. Focus on enterprises and some production lines that are required to be discontinued for various reasons
Iii. Work requirements
ShengJu each related directly affiliated institutions, municipalities (state) food and drug administration (including your Ann district, renhuai, weining map, similarly hereinafter), more attention must be paid according to the requirement of the "double random, a public", will be qualified personnel with inspection certificate within their respective jurisdictions into inspector library, random inspector inspection group of randomly selected enterprises inspected for inspection. All drug manufacturers shall actively cooperate with the tracking and inspection work, and may not conceal the relevant information of the anonymous newspaper during the inspection.
1, strict enforcement of track inspection scheme, faithfully record on-site inspection, fill out the field inspection record in time, after the on-site inspection, the drug GMP certification track inspection report. Each city (state) bureau shall establish a drug GMP tracking record.
Adhere to standards and ensure quality. During the follow-up inspection, strict inspection shall be carried out, and the defective items found shall be rectification in place by the municipal (state) bureau. If there is any violation of laws or regulations, it shall be transferred to the inspection department in a timely manner; The municipal (state) bureau shall, in writing, recommend to the provincial bureau of the drug GMP certificate of its corresponding dosage form in time for the non-conforming drug GMP inspection and evaluation criteria.
To be ordered to make corrections within the prescribed time limit for failing to implement the regulations on quality management of pharmaceutical production in accordance with the provisions of the regulations on the production of pharmaceutical products; To revoke the GMP certificate of the drug in accordance with the provisions of GMP certification; If the circumstances are serious, the drug production license shall be revoked.
4. The results of inspection of drug production enterprises and inspections shall be made public on the local city and state websites.
5. Strict discipline and administration according to law. The supervisory and administrative departments at all levels should clearly supervise and inspect the functions of inspection, do not go through the motions, and eliminate all unsafe hidden dangers. If the regulation is not in place, the problem or the serious consequences of the occurrence of such problems shall be investigated by the relevant laws and regulations and relevant personnel responsibilities.
The inspector should strictly abide by the drug GMP certification examination when checking work discipline, cogent accomplish supervision according to law, science, fairness, honesty and high efficiency, behavior standards, consciously accept the supervision of the disciplinary inspection departments and enterprises, establish a good image of the food and drug supervision and management system.
4. Check work arrangement
To be responsible for the tracking and inspection of high-risk drug production enterprises in the province; The GMP tracking and inspection work of other preparations and apis, traditional Chinese medicine and medical oxygen production enterprises shall be responsible by the food and drug administration of various cities (states).
(I) inspection time: April to November 2017.
(ii) inspection methods:
1. The follow-up inspection shall be combined with routine supervision and inspection, which can be checked with the emphasis of daily supervision and inspection;
2, track inspection and strengthen basic drug production supervision, supervision and basic prescription drug production enterprise in accordance with the statutory standards, processes, quality standards organization production and inspection, timely find drug production process safe hidden trouble, strict enforcement of product recall system, in accordance with national requirements implementing regulation, to ensure the quality and safety of essential medicines.
3. The follow-up inspection shall be combined with the prescription and process verification work to check the traceability of the product prescription and process of the enterprise, whether it shall be produced according to the approved prescription and process organization;
4. In combination with the rectification of problems existing in the inspection and supervision and inspection, the enterprise shall check the rectification status of the food and drug administration departments at all levels;
The on-site inspection shall be used for each inspection of no less than 2 persons. Inspection teams to determine the inspection schedule one day in advance to inform the units under inspection, on-site inspection shall carefully fill in the drug production enterprises GMP checking on-site inspection report (in triplicate), on-site inspection report to the 13 key designed above, check the link and content are listed at the same time, in accordance with the GMP evaluation standard to check the defects found.
Fifth, summarize report
The municipal (state) bureau shall report and report to the provincial bureau of pharmaceutical cosmetics production supervision and administration by November 15, 2017. The summary shall include the following:
(I) checking the overall situation, including checking the number of enterprises, specific implementation procedures and methods of inspection;
(2) the main achievements achieved;
(iii) major problems in enterprise production and quality management;
(4) illegal behaviors and opinions of the enterprise, including the name of the enterprise, the facts of the violation of laws and regulations, the handling basis, and the handling reasons;
(5) the inspection group considers the weak links in supervision, including the system, mechanism, system, methods of supervision and inspection, personnel quality, etc.;
(6) to address the existing problems, the measures taken by enterprises and Suggestions for future work, including the establishment of a long-acting mechanism for strengthening drug production and supervision, and Suggestions.
