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manufacturing practices: validation WHO Technical Report Series No 961, 2011 0 Annex 6 WHO good manufacturing practices for sterile pharmaceutical products WHO Technical Report Series No 986, 2014 0 Annex 2 WHO good manufacturing practices for pharmaceutical products: main principles WHO Technical Report Series No 996, 2016 0 Annex 3 WHO good manufacturing practices for biological products ISPE Baseline Volume5 Commissioning and Qualification ISPE GAMP5 A Risk-Based Approach to Compliant GxP Computerized Systemso倉Y陙≧Su瀃鯈cWS u愇NGxP梴:gS鹼邁T膲剉螛i枴{t筫誰 ISPE A Risk-Based Approach to Compliant Electronic Records and Signatures ISPE Records & Data Integrity Guide ISPE Good Practice Guide Applied Risk Management for Commisioning and Qualification ISPE Science and Risk-Based Approach for the Delivery of Facilities Systems, and Equipment PDA TR No.54-5, Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems, 2017 ICH鴙sQcWSh芉 ASTM E2500 Standard Guide for 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