Taizhou Drug Administration deploys drug packaging production

In order to further strengthen the quality supervision of drug packaging materials in Taizhou City, Zhejiang Province, the Food and Drug Administration of Taizhou City, Zhejiang Province, has recently deployed the production and use of drug packaging materials to all drug packaging materials and pharmaceutical manufacturing companies and medical institution preparation rooms in the city. The special rectification and rectification were carried out in three phases.

The first is the self-checking stage of the company. It is required that all drug packaging material manufacturers conduct self-examination in strict accordance with the requirements of the State Food and Drug Administration's Measures for the Administration of Packaging Materials and Containers Directly in Contact with Drugs, and carry out self-assessment against the "General Rules for the Examination of Pharmaceutical Packaging Materials Production Site". The contents of the self-examination of drug manufacturing companies and medical institutions' preparation rooms requiring the use of drug packaging materials include whether the drug packaging material suppliers are audited and evaluated according to requirements; whether the purchased and used drug packaging materials are inspected as required; Whether the supplier of packaging materials has carried out the experimental research on the compatibility of drug packaging materials and drugs as required; whether the drug packaging materials have been submitted according to the requirements of the “Drug Registration Administration Regulations”, and submitted the self-inspection report and the drug packaging materials. "Self-inspection of production and use conditions"; and require companies to complete self-inspection by July 15.

The second is the supervision and inspection and testing phase. The county (city, district) bureaus (branches) are required to carry out supervision and inspection in accordance with the "Guidelines for the Supervision and Inspection of Daily Production of Drug Production in Zhejiang Province" and the "Measures for the Administration of Packaging Materials and Containers Directly in Contact with Drugs" (Decree No. 13). At the same time, four kinds of high-risk drug packaging materials and some other kinds of suspicious drug packaging materials that require the production and use of plastic infusion bottles, multi-layer co-extruded film infusion bags, butyl rubber stoppers, and easy-to-fold ampoules for all pharmaceutical production enterprises in the city are required. Supervised random inspection. The violations and violations found in the inspections shall be strictly handled in accordance with the relevant laws and regulations; all suspected illegal crimes shall be transferred to the public security organ for handling. Supervision inspections and sampling are completed in principle by August 25, 2012.

The third is to summarize the reporting stage. Requests the county (city, district) bureaus (branches) to sum up the special inspections (including the overall situation of special inspections, major problems found and their handling, weak links in daily supervision, and measures and suggestions for future work, and The assessment of special inspections used in the production of pharmaceutical packaging materials is reported to the municipal office. At the same time, the establishment and improvement of the regulatory archives for the use of pharmaceutical packaging materials in drug packaging material manufacturing enterprises and pharmaceutical production enterprises (including medical institution preparation rooms) in the jurisdiction. The summary requirements will be completed by September 15.