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TRS 953 – Annex 2, Appendix 1: Stability testing of active pharmaceutical ingredients and finished pharmaceuticalproducts: Stability conditions for WHO Member States by Region. Injection Safety Fact Sheet. Woodhead Publishing. Pages 20-27. ISBN 9781855737921. Higashiyama T. Novel functions and applications of trehalose.
Quality by design (QbD) is a concept introduced into the pharmaceutical regulatory lexicon in 2005. Dr Amiji says that these harmonisation guidelines help industry understand the necessary requirements for developing pharmaceuticalproducts. Following QbD to guarantee a drug product'ssafety.
One element that project managers often forget or underestimate is the environmental, health and safety (EHS) tasks” Operating PAT from hardware to software, in a manufacturing suite, would not be successful without training and competency development to track training status in a learning management system for individuals.
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