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翻譯：JULIA 來自：Julia法規翻譯

WHO Working document QAS/20.849
Points to consider on the different approaches – including HBEL – to establish carryover limits in cleaning validation for identification of contamination risks when manufacturing in shared facilities
使用共用設施生產時清潔驗證中為識別污染風險而建立殘留限度的不同方法—包括HBEL—考量要點

1. Introduction and background 概述與背景 4
2. Scope 范圍5
3. Glossary 術語 5
4. Traditional approach傳統方法 6
5. New approaches 新方法 6
5.1 Documentation 文件記錄7
5.2 Equipment 設備7
5.3 Detergents and solvents 清潔劑和溶劑 7
5.4 Sampling 取樣 8
5.5 Cleanability studies 清潔能力研究8
5.6 Risk assessment and risk control 風險評估和風險控制 9
5.7 Technical and organizational controls 技術和組織控制措施 9
5.8 Health Based Exposure Limits (HBELs) setting 基于健康的暴露限度（HBEL）設置 9
5.9 Acceptance criteria 可接受標準 11
5.10 Grouping by therapeutic use 根據治療用途分組 12
5.11 Analytical procedures 分析方法 12
5.12 Data integrity 數據完整性 13
5.13 Cleaning validation and cleaningverification 清潔驗證和清潔核查 13
5.14 Visually clean 目視清潔 14
5.15 Cleaning verification and processcapability 清潔核查和工藝能力 14
5.16 Personnel 人員 14
5.17 Quality metrics and performance indicators 質量量度和性能指標 14
5.18 Life cycle 生命周期 15
References 參考文獻 16

1. Introduction and background 概述與背景
The World Health Organization (WHO) has published the guideline entitled Good Manufacturing Practices for pharmaceutical products: main principles in the WHO Technical Report Series, No. 986, Annex 2, 2014 (1).

WHO在2014年TRS 986附錄2發布了題為“藥品GMP：主則”的指南。

The WHO Supplementary guidelines on good manufacturing practice: validation were published in 2006 and were supported by seven appendices. In 2019, the WHO Good manufacturing practices: guidelines on validation (2) were updated and republished. Some of the seven appendices were also individually updated between 2013 and 2019:
WHO的“GMP補充指南：驗證”于2006年發布，有7個附錄作為支持文件。2019年，WHO的“GMP：驗證指南”進行了更新并重新發布。7個附錄中有幾個分別于2013年和2019年進行了更新。

Appendix 1. Validation of heating, ventilation and air conditioning systems (3).
附錄1：HVAC系統的驗證
Appendix 2. Validation of water systems for pharmaceutical use (4).
附錄2：制藥用水系統的驗證
Appendix 3. Cleaning validation (5).
附錄3：清潔驗證
Appendix 4. Analytical procedure validation (6).
附錄4：分析方法驗證
Appendix 5. Validation of computerized systems (7).
附錄5：計算機化系統的驗證
Appendix 6. Guidelines on qualification (8).
附錄6：確認指南
Appendix 7. Non-sterile process validation (9).
附錄7：非無菌工藝驗證

Appendix 3, relating to cleaning validation (5), was not updated at that time. Its revision, however, was discussed during an informal consultation held in Geneva, Switzerland, in July 2019. The outcome of the discussion was presentedto the WHO Expert Committee on Specifications for Pharmaceutical Products (ECSPP) meeting in October 2019. The ECSPP acknowledged the importance of harmonization in regulatory expectations with regards to cleaning validation approaches. The Expert Committee recommended a “Points to consider” document be prepared in order to describe the current approaches used in cleaning validation and highlighting the complexities involved in order to establish a common understanding. A revision of the relevant appendix would then be considered by the Expert Committee thereafter.
與清潔驗證有關的附錄3當時未更新。但在2019年7月瑞士日內瓦的非正式溝通期間對其修訂進行了討論，討論結果于2019年10月提交給了ECSPP會議。ECSPP了解清潔驗證方法的監管要求保持一致的重要性，因此專家委員會建立起草一份“考量要點”文件，以闡述當前清潔驗證中所用方法，強調其所涉及的復雜性，以求對此達成共識。鑒于此，專家委員會隨后考慮要對相關附錄進行修訂。

Many manufacturers produce products in multi-product facilities where there is arisk of contamination and cross-contamination. Some of the main principles of good manufacturing practices (GMP) include the prevention of mix-ups and the prevention of contamination and cross-contamination. It is therefore important that manufacturers identify all risks for contamination and cross-contamination and identify and implement the appropriate controls to mitigate these risks. These controls include, for example, technical and organizational measures, dedicated facilities, closed systems, cleaning and cleaning validation.
許多生產商會在多產品設施中生產多個產品，這時就會存在污染和交叉污染的風險。優良生產規范（GMP）的一些重要原則包括有防止混淆和防止污染與交叉污染，因此生產商識別所有污染與交叉污染，識別實施適當控制措施以降低這些風險就非常重要。這些控制措施包括例如技術和組織措施、使用專用設施、封閉系統、清潔和清潔驗證。

2. Scope 范圍
The scope of this document is to discuss the different possible approaches –including methods that account for pharmacological and toxicological data (Health-Based Exposure Limits {HBEL}) – that could be used when establishing safe Carryover limits when manufacturing in shared facilities.
本文件的范圍是討論在為使用共用設施生產建立安全殘留限度時可采用的不同方法—包括應用藥理學和毒理學數據（基于健康的暴露限（HBEL））的方法。
This document further provides clarification on cleaning validation and presents points to consider when reviewing the current status and approaches to cleaning validation in multiproduct facilities. It reflects the current regulatory guidance and expectations. It further focuses on approaches where HBELs setting need to be considered in cleaning and cleaning validation approaches.
本文還對清潔驗證進行了澄清，提出回顧多產品設施中當前清潔驗證狀態和方法的考量要點。它反映了當前的監管指南和要求。其中還關注了清潔和清潔驗證方法中需要考慮HBEL時的方法。

The principles should be applied inmanufacturing facilities with active pharmaceutical ingredients (APIs) and finished pharmaceutical products (FPPs).
在API和FPP生產設施中應使用這些原則。
This document should be read in conjunction with the main GMP text and supplementary texts on validation (1-10).
本文應與GMP主則文件和驗證補充文件一起解讀。
英文原文官網下載
https://www.who.int/medicines/areas/quality_safety/quality_assurance/QAS20_849_points_to_consider_on_cleaning_validation.pdf?ua=1
中英文下載鏈接
鏈接：https://pan.baidu.com/s/12O6UYBLScfo-uNposUKFaA
提取碼：42ks