Drug companies release inspection plans and plans in many places

[China Pharmaceutical network industry trends] in the new pharmaceutical environment, flight inspection has become a new normal However, with the release of policies such as the cancellation of GMP and GSP certification, the measures for flight inspection of medical devices, and the announcement on rectifying illegal business activities in the field of drug circulation, the storm of flight inspection swept the whole country Some experts predict that in 2018, the flight inspection of pharmaceutical enterprises is not strict, only stricter This can also be confirmed by flight inspection plans issued from some places Zhejiang: the coverage rate of flight inspection for pharmaceutical enterprises is no less than 20% The author understands that on March 19, Hangzhou municipal market supervision and Administration Bureau of Zhejiang Province issued a notice to print and distribute the flight inspection plan for pharmaceutical enterprises in Hangzhou in 2018 According to the plan, the coverage rate of flight inspection for drug wholesale enterprises and retail chain headquarters shall not be less than 20% In addition, each district, county (city) bureau (sub Bureau) shall carry out flight inspection for wholesale, chain and retail enterprises within its jurisdiction with a coverage rate of no less than 20% It is reported that the contents of the flight inspection include six parts, including providing places, qualification certificates, bills and other conditions for others to illegally trade in drugs; purchasing drugs from individuals or units without the drug production license or drug trade license; Selling drugs to units or individuals without legal qualification, knowing or should know that others are engaged in unlicensed business and still providing drugs for them, etc The flight inspection will start in March and be completed by the end of November Anhui: 15% of pharmaceutical enterprises that announced the plan will be subject to flight inspection on January 30 Anhui issued the work plan for flight inspection of pharmaceutical trading enterprises in 2018, which made Hefei, Fuyang and Bozhou clear as the key areas for flight inspection According to the plan, the coverage rate of flight inspection carried out by Anhui province's drug wholesale enterprises will not be less than 15%, and 16 cities will be fully covered The content of the flight inspection also includes six parts However, unlike Hangzhou, if there are the following behaviors, the drug companies will directly take them as the objects of inspection That is to say, those enterprises with low level of daily management and disordered channels of purchase and sale, those with complaints and reports or clues indicating the existence of quality and safety risks, those with frequent changes in business licensing matters, and those with vaccine distribution will be directly inspected Anhui flight inspection will randomly select the inspection objects Heilongjiang: carry out GMP follow-up inspection for 50 pharmaceutical enterprises (Times) on March 12, and Heilongjiang Province issued the 2018 provincial drug production supervision and inspection plan According to the plan, GMP follow-up inspection will be carried out for 50 (Times) drug manufacturers in the province, special inspection will be carried out for five cases, and flight inspection will be carried out for six cases Special inspection includes the safety of traditional Chinese medicine injection extracts, multi-component biochemical drugs, preparation rooms of medical institutions, legal sources of traditional Chinese medicine extracts, and data reliability Flight inspection includes complaints and reports or other clues indicating that there may be drug quality and safety risks; suspected of seriously violating the requirements of drug quality management specifications; since 2017, the preparation enterprises that have supervised the spot check and found many batches of unqualified products, and the production enterprises that have supervised the spot check and found the products unqualified; Adverse drug reactions / events indicate that there may be drug quality and safety risks; at least one flight inspection shall be carried out for blood product manufacturers in the province; other situations requiring flight inspection shall be carried out Liaoning: the flight inspection will focus on 10 violations March 13, and Liaoning Province also released the 2018 provincial level supervision and inspection plan According to the plan, 50 pharmaceutical manufacturers will be followed up for inspection, 40 pharmaceutical trading enterprises will be mainly inspected for GSP implementation, focusing on 10 illegal acts, and 100 pharmaceutical retail enterprises and clinics will be inspected, 20 medical device manufacturers, 14 medical device trading enterprises and 14 medical device users will be inspected I have learned that the flight inspection will be completed by the end of November Among them, from April to July, 2 medical device manufacturers are inspected every month; from August to November, 3 medical device manufacturers are inspected every month; from May to November, 2 medical device operators and 2 users are inspected every month The flight inspection of medical device manufacturing enterprises is the whole item inspection, and the inspection of medical device operating enterprises and users is the key spot check.