Miller M. The regulatory acceptance of rapid microbiological methods. European Pharmaceutical Review. 2017;3:55-58
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References European Medicines Agency. Inspectors Working Group. Questions and answers on production of water for injections by non-distillation methods – reverse osmosis and biofilms and control strategies. EMA/INS/GMP/489331/2016 GMP/GDP. 2016. www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2016/08/WC500211657.pdf Alternative Methods for Control of Microbiological Quality, European Directorate for the Quality of Medicines & HealthCare. Pharmeuropa. 2017; Chapter 5.1.6. Supplement 9.2 Parenteral Drug […]
References
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