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2014年度翻译计划,暂定。可以根据实际情况调整,如有需要大家也可以补充,另外也请广大的蒲友踊跃参加!!!
1 PDA TR-30 Parametric Release of Pharmaceuticals Terminally Sterilized by Moist Heat(2012)
2 PDA TR-39 Guidance for Temperature-Controlled Medicinal Products: Maintaining the Quality of Temperature-Sensitive Medicinal Products through
the Transportation Environment(2007)
3 PDA TR-51 Biological Indicators for Gas and Vapor-Phase Decontamination Processes: Specification, Manufacture, Control and Use(2010)
4 PDA TR-54 Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations(2012)
5 PDA TR-54-2 Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operation: Annex 1: Case Study
Examples for Quality Risk Management in Packaging and Labeling(2013)
6 PDA TR-54-3 Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations Annex 2 Case Studies in
the Manufacturing of Pharmaceutical Drug Products(2013)
7 ISPE-Commissioning and Qualification(2001)
8 ISPE-Risk-based manufacture of pharmaceutical products(2011)
9 ISPE-Cold Chain Management(2011)
10 ISPE-Process Gases(2011)
11 ISPE-Applied Risk Management for Commissioning and Qualification(2011)
12 ISPE-Science and Risk-Based Approach for the Delivery of Facilities, Systems, and Equipment(2011)
13 ISPE-Assessing the Particulate Containment Performance of Pharmaceutical Equipment(2012)
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