WHO发布《清洁验证指南》、《数据完整性指南》《制药用水GMP指南》_检测资讯

WHO发布《清洁验证指南》、《数据完整性指南》《制药用水GMP指南》

嘉峪检测网 2021-04-02 10:50

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 Specifications for Pharmaceutical Preparations

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 consider 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 Nations Population Fund Recommendations 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 Nations 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 Nations 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 considerations

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》

部分文件目录如下：

Annex4 Guidelineon data integrity

附录4 《数据完整性指南》

1. Introduction and background

介绍和背景

2. Scope

范围

3. Glossary

术语

4. Data governance

数据管理

5. Quality risk management

质量风险管理

6. Management review

管理评审

7. Outsourcing

外包

8. Training

培训

9. Data, data transfer and data processing

数据，数据转移和数据处理

10. Good documentation practices

良好文件记录规范

11. Computerized systems

计算机化系统

12. Data review and approval

数据审核和批准

13. Corrective and preventive actions

纠正和预防措施

References

参考文献

Further reading

拓展阅读

Appendix 1 Using Health-Based Exposure Limits (HBELs) to assessrisk in cleaning validation

附录1使用基于健康的暴露限(HBEL)评估清洁验证的风险

此外，技术报告中提及后续GMP工作计划：

Continue collaboration with the EU, EMA and PIC/S to harmonize guidanceon sterile products and, if feasible, present such guidance for possibleadoption at the next ECSPP meeting, in 2021.

继续与EU、EMA和PIC/S合作，协调无菌产品指南，如果可行，在2021年的下次ECSPP会议上提交该指南以供可能的通过。

Continue preparation of a new IAEA/WHO text on GMP for radiopharmaceuticals forinvestigational use.

继续编写IAEA/WHO关于临床试验用放射性药品GMP的新文件。

Open the WHO guideline on cleaning validation to review, and update it inaccordance with the latest good practices, including the newly adopted Pointsto consider when including health-based exposure limits in cleaning validation.

启动WHO清洁验证指南的审查，并根据最新的良好实践进行更新，包括在清洁验证中使用基于健康暴露限的考量。

Publish the results of the survey of pharmaceutical manufacturers that engagein synthesis and/or production of antimicrobials on their waste and wastewatermanagement practices in a regulatory journal.

在监管期刊上发表对合成和/或生产抗菌素的制药商对其废弃物和废水管理实践的调查结果。

Assist national inspectorates and manufacturers in implementing recommendationsmade in the Points to consider for manufacturers andinspectors: environmental aspects of manufacturing practices forthe preventionof AMR.

协助国家检查员和制造商实施：《制造商和检查员关于防止抗生素耐药性的生产规范的环境方面的考量》。

Update the WHO guidance on Goodmanufacturing practices: supplemental guidelines for the manufacture ofinvestigational

pharmaceutical products for clinical trials in humans.

更新WHO GMP指南:人用临床试验用药生产补充指南。

Determine whether the WHO guidelines on transfer oftechnology in pharmaceutical manufacturing shouldbe updated.

确定是否更新WHO关于制药技术转移的指南。

Explore whether a new guideline is required on good practices during theresearch and development of medicinal products

探讨是否需要制订一个有关药品研发过程中的良好实践指南

来源： GMP办公室

WHO发布《清洁验证指南》、《数据完整性指南》《制药用水GMP指南》

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