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参考文献

[1] 中华人民共和国卫生部令79号.药品生产质量管理规范(2010年修订).

[2] 中华人民共和国卫生部令79号.药品生产质量管理规范(2010年修订):附录 确认与验证.

[3] 国家食品药品监督管理局 药品认证管理中心.药品GMP指南.2011.

[4] EU GMP Annex 15:Qualification and Validation, 2015.

[5] PIC/S PI006-3:Pharmaceutical Inspection Convention, Pharmaceutical Inspection Co-operation Scheme, “Recommendations on Validation Master Plan, Installation and Operational Qualification, Non-sterile Process Validation, Cleaning Validation”, 2007.

[6] ICH Q2(R1):Validation of Analytical Procedures—Text and Methodology, 2005.

[7] ICH Q9:Quality Risk Management, 2005.

[8] ISPE Baseline Volume 5:Commissioning and Qualification, 2001.

[9] ISPE Baseline Volume 7:Risk-Based Manufacture of Pharmaceutical Products, 2010.

[10] ISPE GPG:Applied Risk Management for Commissioning and Qualification,2011.

[11] ISPE Guide:Science and Risk-Based Approach for the Delivery of Facilities, Systems, and Equipment, 2011.

[12] ISPE GAMP5: A Risk-Based Approach to Compliant GxP Computerized Systems, International Society for Pharmaceutical Engineering, 2008.

[13] ASTM E2500-2013:Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment.

[14] USP39<1058> Analytical Instrument Qualification.

[15] WHO TRS937 Annex 4:Supplementary Guidelines on Good Manufacturing Practices: Validation, 2006.