内容提示: 原文翻译,仅供参考! Points to Consider No. 1: Aseptic Processing (Revised 2023) 考虑要点 No.1: 无菌加工(2023 年修订版) 文档格式:PDF | 页数:196 | 浏览次数:437 | 上传日期:2023-10-25 07:19:19 | 文档星级: 原文翻译,仅供参考! Points to Consider No. 1: Aseptic Processing (...
近日PDA发布了《Points to Consider No. 1: Aseptic Processing (Revised 2023)》,即《考虑要点1:无菌加工(2023 年修订版)》,该版本作为2022 年 8 月修订版《欧盟 GMP 附录 1:无菌药品生产》发布后的首次修订,受到了业内广泛的关注,虽然其并不代表监管指南,但该文件提供了 PDA专家组对于部分重要话题的想法,有...
PDA在其2018年5月/ 6月PDA制药科学与技 术期刊上发表了题为《PDA讨论要点:文档/数据管理与控制以及数据可靠性为准备检查的 最佳实践(PDA Points to Consider: Best Practices fOr Document/Data Management and Control and Preparing for Data Integrity Inspections)》的文章,该文章包括对11个数 据完整性相关的问...
PDA TR29清洁验证考虑要点.docx,Technical Report No. 29 (Revised 2012) Points to Consider for Cleaning Validation Paradigm Change in Manufacturing OperationsSM PDA Task Force on Technical Report No. 29 (Revised 2012): Points to Consider for Cleaning Valida
2010Technical Report No. 49 Points to Consider for Biotechnology Cleaning Validation
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The FDA Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use also provides information on viral clearance expectations.FDA在制造和测试供人类使用的单克隆抗体产品时要考虑的要点也提供了有关病毒清除预期的信息。In biopharmaceutical processes, typically two or more ...
PDA Points to Consider: Best Practices for Document/Data Management and Control and Preparing for Data Integrity InspectionsPDA has identified eleven current questions related to data management and control that have been frequently cited in ... A Deb,K Zena,T Ron,... - 《Pda J Pharm Sci Tec...
Technical Report No. 29 Revised 2012Points to ConsiderCleaning Paradigm Change in Manufacturing OperationsSMPDA Task For
Points to consider are provided to facilitate the collection of data in support of a regulatory filing for the approval of a biopharmaceutical drug substance intended to be used in a pharmaceutical product. The science-based practices provided here are grounded in the experiences of a PDA task ...