Pharmaceutical companies through the API GMP certification on-site inspection


Release time:

2015-07-08


From June 25 to 28, the inspection team appointed by Zhejiang Drug Certification and Inspection Center conducted GMP certification on-site inspection on the production and quality management of cephalosporin bulk drugs (cefmenoxime hydrochloride), sterile bulk drugs (azithromycin sulfate) and bulk drugs (L-aspartate amlodipine and paroxetine hydrochloride) of Jianfeng Pharmaceutical Company.
According to the inspection plan and the relevant provisions of the Good Manufacturing Practice (Revised in 2010), the inspection team learned about the overall situation of the company's implementation of GMP by consulting the company's quality management documents, production management documents, and process procedures for certified products, etc., and inspected the warehouse, three API production lines, public systems, laboratories, etc. on the spot, and communicated with relevant personnel, relevant management systems, documents, original records, deviation records, change records, supplier data, annual product review, API impurity files, relevant verification and confirmation data, etc. were checked to verify whether the production process is consistent with the registered process database of the provincial bureau, whether the production equipment matches the production capacity, the audit of material suppliers, the full inspection of raw and auxiliary materials, the cleaning verification of equipment and measures to prevent cross-contamination, etc. The inspection team also focused on the verification of the sealing confirmation equipment of the three-in-one equipment. Simulated filling test of culture medium; Sterility assurance and sterilization verification in aseptic production; Quality control of internal packaging materials and sterility inspection of finished products; Establishment of impurity files for bulk drugs; The integrity and authenticity of enterprise data, and some original electronic data for inspection, verification and stability inspection were selected for audit tracking.
Through the four-day careful inspection by the inspection team and risk assessment, it is believed that the personnel and organization of the pharmaceutical company are sound, the layout of the production workshop is basically reasonable, and the production equipment and testing instruments can meet the production and quality inspection requirements. The overall risk of the three production lines of cephalosporin bulk drug, sterile bulk drug and bulk drug applied for certification is controllable, and the production quality management meets the requirements of the Pharmaceutical Production Quality Management Standard (2010 Revision), no serious defects are found in the on-site inspection and approval is granted.