WHO TRS1019 附录 3-GMP 验证指南,附录 5,计算机化系统的验证,2019.pdf,Annex 3 Good manufacturing practices:guidelines onvalidation Background The need for revision of the published World Health Organization (WHO) Supplementary guidelines on good manufact
https://www.who.int/medicines/areas/quality_safety/quality_assurance/SupplementaryGMPValidationTRS937Annex4.pdf?ua=1). 1.Principle原则138 2.Scope范围138 3.General概述139 4.Cleaning validation protocols and reports清洁验证方案和报告139 5.Personnel人员142 6.Equipment设备142 7.Detergents清洗剂142 8.Mic...
Geneva: World HealthOrganization; 2006: Annex 4 (WHO Technical Report SeriesNo. 937; 附录 3:清洁验证。在:世界卫生组织药物制剂规范专家委员会第四十次报告。日内瓦世界卫生组织;2006:附件 4(世卫组织技术报告系列,第 937 号; ). 1.Principle 原则 138 2.Scope 范围 138 3.General 概述 139 4.Cleaning...
Geneva: World HealthOrganization; 2006: Annex 4 (WHO Technical Report SeriesNo. 937; 附录3:清洁验证。在:世界卫生组织药物制剂规范专家委员会第四十次报告。日内瓦世界卫生组织;2006:附件4(世卫组织技术报告系列,第937号; /medicines/areas/quality_safety/quality_assurance/SupplementaryGMPValidationTRS937Annex4...
Annex 3 Good manufacturing practices: water for pharmaceutical use 优良生产规范( GMP ): 制药用水 Background 背景 Unlike other product or process ingredients, water is usually drawn from an on demand system and is not subject to testing and batch or lot release prior to use. Thus it is ...
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WHO Expert Committee on Specifications for Pharmaceutical Preparations Fifty-fifth report 2021 Annex 2 Points to consider when including Health-Based Exposure Limits (HBELs) in cleaning validation Annex 2 附录2 Points to consider when including Health-Based Exposure Limits (HBELs) in cleaning validation...
Annex2 WHOguidelinesonqualityriskmanagement 1.Introduction62 1.1Backgroundandscope62 1.2Principlesofqualityriskmanagement64 2.Glossary67 3.Qualityriskmanagementprocess70 3.1InitiatingaQRMprocess70 3.2PersonnelinvolvedinQRM70 3.3Knowledgeoftheproductandprocess71 ...
Annex4(WHOechnicalReport SeriesNo.937; 附录&清沽验证。在:世界卫生组织药物制剂规范专家委员会第四十次报告。日内瓦世界卫主组 织;2006:附件4(世卫组织技术报告系列,第93丁号; https:Z/ A whzi?int/medicines/aieas/qualify_safety/ AA quality__assurance,/Supp1einenta ...
The overarching text presented in this annex constitutes the general principles of the new guidance onvalidation. 本附件中呈现的总体文本构成了新验证指南的一般原则。 The following appendices included in this annex address specific aspects of validation and are intended to complement the general text on...