The frequent changes of drug quality control personnel to be checked.

TextThree-earedtube changes too often, to be checked! On July 2,, the General Division of the State Drug Administration issued the Regulations on the Administration of Drug Inspection (Draft for Comments) (hereinafter referred to as the "Regulations"), which the public can give feedback by July 17, according to the Regulations, inspection institutions and personnel, inspection procedures, licensing inspection, routine inspection, due to inspection, processing of inspection results, cross-regional inspection of the collaboration and other content are requiredRefusal, evasion, delay or obstruction of inspection shall be considered a security riskthe Regulations, the provisions apply to the domestic after-market drug production, operation, use of the implementation of inspection, investigation, disposal and other supervision and management, inspection is divided into licensing inspection, routine inspection, cause-by-cause inspection, other inspectionIn other words, the Regulations cover all aspects of the drug, not just the production processin the division of state and authority, the state drug inspection and management, the organization of drug inspection abroad, supervision and guidance of the provincial drug supervision departments, the organization of investigation and punishment of major violations of the lawtheProvincial Bureau shall be responsible for the relevant inspections of drug market license holders, pharmaceutical manufacturers, pharmaceutical wholesale enterprises, pharmaceutical retail chain headquarters, third-party platforms for drug network transactions and other relevant inspections within the administrative area, and shall guide the inspection of the municipal drug regulatory departmentsThe provinces may carry out entrusted inspections according to the actual situation and carry out extended inspections within and outside the provinceand the municipal and county-level drug supervision departments are responsible for carrying out the inspection of drug retail enterprises and user units within their jurisdiction, and with the inspection organized by the national and provincial drug regulatory departmentsgenerally speaking, personnel changes are company behavior, but if quality managers change too often, then the problem arises."In accordance with the Regulations on Management, enterprises frequently change the registration of quality management personnel, is to be carried out for reasons of inspectionOne reason, perhaps, is that the change of personnel is too frequent must be demonin addition, the inspection also includes the report of complaints, inspection found that there is a quality and safety risk, the enterprise serious non-compliance, serious violations of quality management norms, the authenticity of the declaration materials, adverse reaction monitoring there are quality and safety risks the Regulations on Management, it is clear that the construction of inspection teams should be strengthened, the road to professionalization should be opened, and a system of inspectors at the four levels of primary, intermediate, senior and expert levels should be established, with regular training The implementation of cross-regional inspection of collaboration, inspection results to implement mutual recognition, for jurisdictional disputes, reported to the State Drug Administration designated jurisdiction of concern is that the "Regulations" in accordance with the laws and regulations, "Drug Management Supervision and Management Measures", that is, this management measures are being developed Although the Regulations do not have "electronic documents and paper documents have the same legal effect", but according to industry sources, the above-mentioned provisions will be written into the "Drug Management Measures." If the rumors are true, then similar to the realization of the first camp information, inspection report online exchange of 001 pharmaceutical electronic data management platform and other third-party service providers will have great development GSP Office believes that the domestic market after the production, operation, use of the drug inspection, means that the whole process of strengthening supervision, as a quality control personnel, any small error can not appear, to maintain continuous compliance, is the way of development.