It only takes 63 working days for Shaanxi GMP certification from July 6

Medical network, June 27, June 26, the reporter learned from the provincial drug regulatory bureau that in order to further promote the reform of "release management service", optimize the GMP certification process, and shorten the certification time, the Bureau recently issued several provisions on the certification management of Shaanxi pharmaceutical production quality management specifications (hereinafter referred to as the "provisions"), which made it clear that since July 6, 2019, the provincial pharmaceutical production quality management specifications GMP certification has been compressed from 145 working days to 63 working days It is clear in the regulations that after the formal and technical examination of the application materials of enterprises, the technical examination materials and formal examination materials that need to be supplemented and corrected will be informed to enterprises once and for all At the same time, the regulations further refine the certification procedures and shorten the processing time limit After the inspection team has formed the on-site inspection report, the drug technical audit and inspection center needs to combine with the enterprise Rectification: the on-site inspection report shall be comprehensively evaluated and publicized in accordance with the guiding principles for risk assessment of drug production on site inspection of the State Administration After the publicity period expires, the comprehensive evaluation opinions and relevant materials shall be submitted to the production supervision office of the provincial drug administration, and the production supervision office shall conduct administrative review and approval on the comprehensive evaluation and relevant materials of the drug technology audit and inspection center The certification processing time limit is 63 working days, including 2 working days for application acceptance, 40 working days for technical review, on-site review and comprehensive evaluation, 10 working days for publicity, 10 working days for administrative approval, and 1 working day for certificate issuance and delivery The time required for supplementary information, rectification of defects and investigation and verification shall not be included in the prescribed time limit   At the same time, it is emphasized in the regulations that the enterprises applying for certification or stakeholders shall not send gifts, gifts, payment vouchers and securities to the staff (including inspectors and experts, the same below); the staff shall not eat, take, card, ask for and reimburse expenses to the enterprises applying for certification or stakeholders in various names, and shall not provide the enterprises applying for certification without the appointment or authorization of the Provincial Bureau Any paid consulting service and no selling or forcing the enterprise to purchase equipment, instruments, books, software, documents, materials and other items from the enterprise applying for certification are allowed The staff are required to strictly implement the certification discipline and establish a good image of the drug regulatory department.