Pharmaceutical Company Accepts Flight Inspection by Jinhua Municipal Bureau
Release time:
2020-08-14
Pharmaceutical Company Accepts Jinhua Municipal Bureau Flight Inspection
News 9# July 26 Morning, Relevant Personnel of Pharmaceutical Company GMP Self-inspection Team in Jinxi Pharmaceutical Factory are preparing to continue self-inspection work. Quality Director Zhang Weidong suddenly received a notice from Jinhua Food and Drug Evaluation and Certification Center that the flight inspection team appointed by the center arrived at Jinxi Pharmaceutical Factory immediately, after receiving the notice, the self-inspection team decided to complete the remaining self-inspection work while accepting the flight inspection. After a brief explanation of the situation, the
flight inspection team was divided into 3 groups to conduct on-site inspections of high-risk production lines, warehouses and central laboratories such as freeze-drying, powder injection and sterile bulk drugs in Jinxi Factory. The inspection team spot-checked the batch production records and batch inspection records of penciclovir and cefmenoxime acid for injection, and checked the relevant data of relevant varieties such as process procedures, process verification, air conditioning system verification, water system verification, culture medium simulation filling, etc. The inspection team also verified the filing of changes in BA2017-722 , BA2018-530 production workshops. After two days of inspection, the pharmaceutical company successfully passed the city bureau's flight inspection.
After the inspection, the pharmaceutical company organized relevant personnel to conduct cause analysis and risk assessment for the defective clauses found in the inspection, and instructed relevant departments to carry out rectification and report the rectification report in a timely manner. (Huang Lingxiao)
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