質(zhì)量風(fēng)險(xiǎn)管理與藥品檢查孫京林(1)(參考版)
2025-01-09 09:18本頁(yè)面
【正文】 ?關(guān)鍵偏差應(yīng)當(dāng)被調(diào)查并且應(yīng)當(dāng)擴(kuò)大調(diào)查批次的范圍對(duì)那些可能已經(jīng)與特定的失敗或偏差有關(guān)批次的進(jìn)行調(diào)查 藥品認(rèn)證管理中心 PSD1 PSD5 PSD3 PSD2 PSD4 檢查最終結(jié)果 PSD3 ?QC ?生產(chǎn) ?包裝 ?庫(kù)房 ?QA ?環(huán)境監(jiān)測(cè) 檢查結(jié)果 藥品認(rèn)證管理中心 質(zhì)疑 “完美” 結(jié)果 ?取樣位置 : 塵埃粒子計(jì)數(shù)，取樣管長(zhǎng)度 ?布點(diǎn)以及設(shè)置沉降菌、浮游菌取樣點(diǎn)的原理 藥品認(rèn)證管理中心 參考資料 ? PDA技術(shù)報(bào)告 44，無(wú)菌工藝質(zhì)量風(fēng)險(xiǎn)管理 PDA Technical Report 44, Quality Risk Mangement for Aseptic Process ? PDA技術(shù)報(bào)告 28， 藥品化學(xué)品無(wú)菌半成品工藝模擬測(cè)試 PDA Technical Report 28, process simulation Testing for sterile Bulk Pharmaceutical Chemicals ? ISPE， 制藥工業(yè)潔凈車間設(shè)計(jì)及建設(shè)優(yōu)良工程規(guī)范 ISPE, Good Engineering Practices for clean room design and construction for Pharmaceutical Industry ? ICH Guideline – Pharmaceutical Quality System Q10. June 2022 ? A Risk Management Solution Designed To Facilitate RiskBased Qualification, Validation and Change Control Activities Within GMP And Pharmaceutical Regulatory Compliance Environments In The EU. Journal of GXP Compliance, July 2022, Volume 10, Number 4 藥品認(rèn)證管理中心 ? Failure Modes: Simple Strategies for Improving Qualitative Quality Risk Management Exercises during Qualification, Validation, and Change Control Activities Journal of Validation Technology, February 2022, Volume 13, Number 2 ? Risk Management for Pharmaceutical Change Control. William Harclerode and Christophe Noualhac. American Pharmaceutical Review. 2022, 10 (6), 14. ? FDA Guidance for Industry Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products – July 1997 ? Heath Canada Guidance Document – PostNotice of Compliance (NOC) Changes: Quality Document. Effective Date: September 2022 ? Inspection of Utilities Aide Memoire PICS ? TRS 929, Annex 3 WHO Good Manufacturing Practices: water for pharmaceutical use. 參考資料 藥品認(rèn)證管理中心 ? TRS 937, Annex 4 Supplementary guidelines on good manufacturing practices: validation ? Appendix 1 Validation of heating, ventilation and airconditioning systems ? Appendix 2 Validation of water systems for pharmaceutical use Risk Management for Pharmaceutical Change Control. William Harclerode and Christophe Noualhac. American Pharmaceutical Review. 2022, 10 (6), 14. ? ICH三方協(xié)調(diào)指導(dǎo)原則，質(zhì)量風(fēng)險(xiǎn)管理， Q9 ICH HARMONISED TRIPARTITE GUIDELINE, QUALITY RISK MANAGEMENT, Q9 ? WHO GMP TRS 908 Annex7 – Application of Hazard Analysis and Critical Control Point (HACCP) method to pharmaceuticals. ? PICs GMP , Annex 20 Quality Risk Management 參考資料 藥品認(rèn)證管理中心 ?謝謝！ 。 藥品認(rèn)證管理中心 怎樣調(diào)查關(guān)鍵偏差 ?關(guān)鍵偏差應(yīng)當(dāng)被調(diào)查并且調(diào)查的過(guò)程和結(jié)論應(yīng)以文件的形式記錄下來(lái) ?關(guān)鍵偏差應(yīng)當(dāng)被調(diào)查和解決 ?關(guān)鍵偏差應(yīng)當(dāng)被調(diào)查并且結(jié)論應(yīng)被記錄 。 ?偏差與變更一樣可能給制品帶來(lái)風(fēng)險(xiǎn) 。 ?任何背離既定程序的偏差都應(yīng)進(jìn)行記錄并作出解釋 。問(wèn)問(wèn)題：可能發(fā)生哪些潛在的可能影響患者安全或監(jiān)管注冊(cè)的問(wèn)題？ 批準(zhǔn)變更請(qǐng)求 確認(rèn)每個(gè)潛在問(wèn)題的嚴(yán)重性、可能性和可測(cè)性，并確認(rèn)總體風(fēng)險(xiǎn)。 評(píng)估活動(dòng)事項(xiàng)是否實(shí)際執(zhí)行，執(zhí)行后的結(jié)果及其風(fēng)險(xiǎn)是否可接受 。變更許可 。 ?在變更控制提議被批準(zhǔn)前 ， 應(yīng)明確該變更的潛在風(fēng)險(xiǎn)并確定管理這些風(fēng)險(xiǎn)的策略 。 ?提出的變更通常包括大量的資本開支和大型項(xiàng)目團(tuán)隊(duì) ，而有時(shí)由變更引入的重要風(fēng)險(xiǎn)并未被識(shí)別出來(lái) 。 (加拿大 衛(wèi)生部 )(Health Canada) ?變更管理： 提出、評(píng)估、批準(zhǔn)、執(zhí)行及審核回顧變更的系統(tǒng)性方法。 (WHO/PICs) ?變更控制： 是一項(xiàng)書面規(guī)程。通過(guò)此系統(tǒng)，有適當(dāng)專業(yè)背景的有資質(zhì)的代表對(duì)提議的或?qū)嶋H的可能影響到設(shè)施、系統(tǒng)、設(shè)備或工藝驗(yàn)證狀態(tài)的變更進(jìn)行審核。 ?變更可能為制品帶來(lái)風(fēng)險(xiǎn) /對(duì)制品的風(fēng)險(xiǎn)也可能會(huì)給生命安全造成
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