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| T/CNPPA 3009-2020 Technical guidance for research on changes of pharmaceutical packaging (English Version) |
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Introduction of T/CNPPA 3009-2020
本标准规定了药包材变更分类、变更项目与变更内容、技术类变更研究、综合评估及变更研究应用。
本标准适用于指导药包材登记人对药包材生产过程中发生的变更开展相应的研究，并对研究结果予以评估，供药品上市许可持有人参考。
Contents of T/CNPPA 3009-2020