T/CNPPA 3009-2020 Drug packaging material change research technical guidelines

Scope

Main technical content: The changes to pharmaceutical packaging materials in this standard refer to the changes in raw materials, production processes, quality standards, etc. that occur during the production of pharmaceutical packaging materials selected for marketed drugs. The research and evaluation of changes to pharmaceutical packaging materials should be based on the research and data accumulation from previous actual production processes, and conducted in accordance with the provisions of this standard and relevant regulations. Through in-depth research and evaluation of changes to pharmaceutical packaging products, production processes, and quality control, continuous improvement and innovation of marketed pharmaceutical packaging materials can be achieved. The change research conducted by pharmaceutical packaging manufacturers in accordance with this standard cannot replace the research and evaluation by the drug marketing authorization holders of the impact of changes to pharmaceutical packaging materials on drug quality. Drug marketing authorization holders shall, in accordance with relevant technical guidance principles, comprehensively evaluate and verify the impact of changes to pharmaceutical packaging materials on drug safety, efficacy, and quality controllability. Due to the wide range and diversity of pharmaceutical packaging products and the complexity of changes, this standard may not be applicable to all pharmaceutical packaging products and changes. Pharmaceutical packaging manufacturers may refer to this standard and conduct research and evaluation on relevant changes to pharmaceutical packaging materials in accordance with the principles of risk assessment.

Development Information

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