WHO发布《清洁验证指南》、《数据完整性指南》《制药用水GMP指南》

WHO发布《清洁验证指南》、《数据完整性指南》《制药用水GMP指南》

3月29日，WHO发布了第 55 届药物制剂规范专家委员会（ECSPP）技术报告TRS No.1033，其中发布了以下文件终稿：

﹒Annex 1Guidelinesand guidance texts adopted by the Expert Committee on Specificati** for Pharmaceutical Preparati**

﹒附录1 《药物制剂规范专家委员会通过的指南和指导文件》

﹒Annex2Pointsto c**ider when including Health-Based Exposure Limits (HBELs) in cleaning validation

﹒﹒附录2 《在清洁验证中应用基于健康的暴露限度(HBELs)的考量》

﹒Annex3Goodmanufacturing practices: water for pharmaceutical use

﹒附录3 《制药用水GMP指南》

﹒Annex4 Guidelineon data integrity

﹒附录4 《数据完整性指南》

﹒Annex5WorldHealth Organization/United Nati** Population Fund Recommendati** for condom storage and shipping temperatures

﹒附录5 《WHO/联合国人口基金关于避孕套储存和运输温度的建议》

﹒Annex6WorldHealth Organization/United Nati** Population Fund Guidance on testing of male latex condoms

﹒附录6 《WHO/联合国人口基金关于男性乳胶避孕套测试的指南》

﹒Annex7WorldHealth Organization/United Nati** Population Fund guidance on conducting post-market surveillance ofcondoms

﹒附录7 《WHO/联合国人口基金关于避孕套上市后监测的指南》

﹒Annex8WHO“Biowaiver List”: proposal to waive in vivo bioequivalence requirements forWHO Model List of Essential Medicines immediate-release,solid oral dosage forms

﹒附录8 《WHO“生物等效性清单”: 建议放弃《WHO速释固体口服剂型基本药物标准清单》的体内生物等效性要求》

﹒Annex9Guidelineson the implementation of the WHO Certification Scheme on the quality of pharmaceutical products moving ininternational commerce

﹒附录9 《关于实施WHO国际贸易药品质量认证计划的指南》

﹒Annex10Goodreliance practices in the regulation of medical products: high level principles and c**iderati**

﹒附录10 《医药产品监管中的良好依赖规范：高级原则和考虑事项》

﹒Annex11Goodregulatory practices in the regulation of medical products

﹒附录11 《医药产品监管方面的良好监管规范》

技术报告下载：WHO 技术报告 1033.pdf

来源：GMP办公室