The latest notice of the drug supervision: drug production enterprises to check come!

Medicine Network August 14th, pharmaceutical production enterprises to check, cameOn August 13, jiangxi province's drug regulatory bureau issued a "notice on the self-examination and self-correction of the risks of drug production to implement the responsibility of the main body of the enterprise."according to the notice, Jiangxi will carry out drug production risks in the province self-examination and self-correction work, and establish the implementation of the main responsibility of the periodic report system, self-examination scope includes: pharmaceutical production enterprises (including Chinese medicine tablets, excluding medical oxygen production enterprises), Chinese medicine extract production enterprises, medical institutions preparation roomfirst reported until December 20, 2019Since then, regular reports, as follows:1, the use of injection-containing enterprises to implement semi-annual reports, each year at the end of June and the end of December2, non-injection drug production enterprises, Chinese medicine extract production enterprises, medical institutions preparation room to implement the annual report, once a year at the end of Decemberto strictly check the production processprocess verification, is a major event in thepharmaceuticalindustry, but also in recent years, an important work of the regulatory authoritiesJiangxi this drug production risk hidden dangerself self-correction, but also highlighted this aspectthe above-mentioned notice clearly, the focus of self-examination includes: whether theproducts in strict accordance with the approved prescription and production process, production scope, organization of production, whether to establish a drug and extract variety file (including statutory standards, processes and related parts, etc.,enterprisesaround the standards, processes, such as internal control standards, production processes, operating procedures, etc.);and stressed that due to the change in the acquisition rate of Chinese medicine, the material balance fluctuates greatly, the whole process of production (including extraction process and preparation process) should be recorded truthfully on the basis of insisting on truth-seeking talk about unauthorized changes to production processes, which have not been uncommon in recent years The most representative is the Ginkgo Bibo wave of 2015 In this round of turmoil, Guilin Xingda Pharmaceutical sin was found in a flight inspection unauthorized changes in the extraction process and other illegal acts, and was finally suspended drug production license In August 2016, the former State Administration of Food and Drug Administration issued a "Announcement on the Implementation of Drug Production Process Verification" (Draft for Comments), requiring pharmaceutical manufacturers to conduct self-examination of each approved drug production process from the date of the announcement and stressed that according to the results of self-examination by pharmaceutical companies, if the actual production process and the approved production process is not consistent, requires adequate research and verification If the change in the production process has no effect on the quality of the drug, the pharmaceutical production enterprise shall make a supplementary application in accordance with the Measures for the Administration of Drug Registration If the change in the production process has an impact on the quality of the drug, the enterprise shall immediately stop production tampering with the production process will not only affect the active ingredients of the drug, but also affect the efficacy of the drug, which in turn will adversely affect the user Therefore, in the next relevant departments of supervision work, strict inspection of the production process is the top priority inspection is becoming more and more stringent
from the state's flight inspection and tracking inspection of pharmaceutical manufacturers, in recent years, the inspection efforts are gradually increasing according to the 2015 Drug Inspection Report of the of the , 59 enterprises were subjected to drug flight inspections in 2015, of which 22 were recovered from their GMP certificates, 6 had their drug production licenses revoked and 3 were prosecuted the 2016 Drug Inspection Report showed that in 2016, a total of five manufacturers of chemical and biological drugs were tested, the results of the inspection were not passed, 4 were withdrawn GMP certificates, and four were asked to recall products the 2017 Annual Drug Inspection Report, which shows that 315 high-risk companies and 150 "double random" companies are scheduled to follow up in 2017 Of these, 37 enterprises do not have on-site inspection conditions for failure to drug GMP certification, drug GMP certificate was withdrawn, and no corresponding drug approval number in fact, as early as 2007, the State Drug Administration has proposed that the drug production link special regulatory action next step to focus on the production process inspection, supervision of pharmaceutical production enterprises in accordance with the approved process organization of production, never allow any excuse to change the production process and prescriptions without authorization this aspect is the minefield of many pharmaceutical companies Industry insiders said, because pharmaceutical companies originally declared a drug, its process, etc are reported in accordance with laboratory data In the actual production, due to environmental and equipment changes, the stability of drugs may be a problem, then pharmaceutical companies have to make adjustments to the process, so as to obtain relatively correct data for flight inspection and other kinds of inspection under the new version of GMP's hardware and software requirements and strict flight inspection, for pharmaceutical companies, there is also a fatal factor is profit Some small and medium-sized pharmaceutical companies once the formal operation, in the face of profits appear completely uncompetitive As a result, there are non-compliance sprees such as simplifying production processes and tampering with production processes The previous the next page the of the 1