T/CNPPA 3005-2019 Guidelines for Quality Management of Drug Package Materials Production

Scope

Main technical content: This standard aims to guide pharmaceutical packaging material manufacturers in establishing a quality management system to ensure that the products they produce meet the quality requirements of their intended design. This standard can be used for internal or external certification of pharmaceutical packaging material manufacturers and for contractual purposes with customers, and can also be used by pharmaceutical companies as a reference for auditing pharmaceutical packaging material suppliers. In this guide, the bold characters represent basic requirements, and the italic characters represent the practices of some enterprises, which can be used as a reference for users. This standard is an application guide for the design, manufacture, and supply of pharmaceutical packaging materials. The pharmaceutical packaging materials referred to in this standard refer to packaging systems (including functional secondary packaging materials), components, drug delivery devices, and printed packaging materials that come into direct contact with drugs. The requirements involved apply to pharmaceutical packaging material enterprises and their important suppliers.

Development Information

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