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3月29日，WHO發(fā)布了第 55 屆藥物制劑規(guī)范專家委員會（ECSPP）技術報告TRS No.1033，其中發(fā)布了以下文件終稿：

 

Annex 1Guidelinesand guidance texts adopted by the Expert Committee on Specifications for Pharmaceutical Preparations

 

附錄1 《藥物制劑規(guī)范專家委員會通過的指南和指導文件》

 

Annex2Pointsto consider when including Health-Based Exposure Limits (HBELs) in cleaning validation

 

附錄2 《在清潔驗證中應用基于健康的暴露限度(HBELs)的考量》

 

Annex3Goodmanufacturing practices: water for pharmaceutical use

 

附錄3 《制藥用水GMP指南》

 

Annex4 Guidelineon data integrity

 

附錄4 《數(shù)據(jù)完整性指南》

 

Annex5WorldHealth Organization/United Nations Population Fund Recommendations for condom storage and shipping temperatures

 

附錄5 《WHO/聯(lián)合國人口基金關于避孕套儲存和運輸溫度的建議》

 

Annex6WorldHealth Organization/United Nations Population Fund Guidance on testing of male latex condoms

 

附錄6 《WHO/聯(lián)合國人口基金關于男性乳膠避孕套測試的指南》

 

Annex7WorldHealth Organization/United Nations Population Fund guidance on conducting post-market surveillance ofcondoms

 

附錄7 《WHO/聯(lián)合國人口基金關于避孕套上市后監(jiān)測的指南》

 

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

 

附錄8 《WHO“生物等效性清單”: 建議放棄《WHO速釋固體口服劑型基本藥物標準清單》的體內生物等效性要求》

 

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

 

附錄9 《關于實施WHO國際貿易藥品質量認證計劃的指南》

 

Annex10Goodreliance practices in the regulation of medical products: high level principles and considerations

 

附錄10 《醫(yī)藥產品監(jiān)管中的良好依賴規(guī)范：高級原則和考慮事項》

 

Annex11Goodregulatory practices in the regulation of medical products

 

附錄11 《醫(yī)藥產品監(jiān)管方面的良好監(jiān)管規(guī)范》

 

部分文件目錄如下：

 

Annex4 Guidelineon data integrity

 

附錄4 《數(shù)據(jù)完整性指南》

 

1. Introduction and background

 

介紹和背景

 

2. Scope

 

范圍

 

3. Glossary 

 

術語

 

4. Data governance

 

數(shù)據(jù)管理

 

5. Quality risk management

 

質量風險管理

 

6. Management review

 

管理評審

 

7. Outsourcing

 

外包

 

8. Training

 

培訓

 

9. Data, data transfer and data processing

 

數(shù)據(jù)，數(shù)據(jù)轉移和數(shù)據(jù)處理

 

10. Good documentation practices

 

良好文件記錄規(guī)范

 

11. Computerized systems

 

計算機化系統(tǒng)

 

12. Data review and approval

 

數(shù)據(jù)審核和批準

 

13. Corrective and preventive actions

 

糾正和預防措施

 

References

 

參考文獻

 

Further reading

 

拓展閱讀

 

Appendix 1 Examples in data integrity management

 

附錄1 數(shù)據(jù)完整性管理示例

 

Annex Pointsto consider when including Health-Based Exposure Limits (HBELs) in cleaning validation

 

附錄2 《在清潔驗證中應用基于健康的暴露限度(HBELs)的考量》

 

1. Introduction and background

 

介紹和背景

 

2. Scope

 

范圍

 

3. Glossary

 

術語

 

4. Historical approach in cleaning validation

 

驗證驗證的傳統(tǒng)方法

 

5. New approach using HBELs in cleaning validation

 

使用HBEL的新方法進行清潔驗證

 

5.1 Documentation

 

文件

 

5.2 Equipment

 

設備

 

5.3 Cleaning agents

 

清潔劑

 

5.4 Sampling 

 

取樣

 

5.5 Cleanability studies

 

可清潔性研究

 

5.6 Risk management

 

風險管理

 

5.7 Guidance for Health-Based Exposure Limits (HBELs) setting

 

基于健康的暴露限（HBEL）設置的指南

 

5.8 Acceptance criteria

 

接受標準

 

5.9 Analytical procedures

 

分析方法

 

5.10 Data integrity

 

數(shù)據(jù)完整性

 

5.11 Cleaning validation and cleaning verification

 

清潔驗證和清潔確認

 

5.12 Visually clean

 

目視清潔

 

5.13 Cleaning process capability

 

清潔工藝能力

 

5.14 Personnel

 

人員

 

5.15 Life cycle

 

生命周期

 

References

 

參考文獻

 

Further reading

 

拓展閱讀

 

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

 

附錄1使用基于健康的暴露限(HBEL)評估清潔驗證的風險

 

此外，技術報告中提及后續(xù)GMP工作計劃：

 

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.

 

繼續(xù)與EU、EMA和PIC/S合作，協(xié)調無菌產品指南，如果可行，在2021年的下次ECSPP會議上提交該指南以供可能的通過。

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

 

繼續(xù)編寫IAEA/WHO關于臨床試驗用放射性藥品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.

 

啟動WHO清潔驗證指南的審查，并根據(jù)最新的良好實踐進行更新，包括在清潔驗證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.

 

在監(jiān)管期刊上發(fā)表對合成和/或生產抗菌素的制藥商對其廢棄物和廢水管理實踐的調查結果。

 

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

 

協(xié)助國家檢查員和制造商實施：《制造商和檢查員關于防止抗生素耐藥性的生產規(guī)范的環(huán)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:人用臨床試驗用藥生產補充指南。

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

 

確定是否更新WHO關于制藥技術轉移的指南。

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

 

探討是否需要制訂一個有關藥品研發(fā)過程中的良好實踐指南