LCGC Europe-11-01-2015

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LCGC Europe

Primary record is a term that was defined by the MHRA (Medicines and Healthcare products Regulatory Agency, the UK drug regulator) in data integrity guidance issued in 2015. In this instalment of Questions of Quality we explore what this term means in practice, and compare it with raw data in the European Union Good Manufacturing Practices (EU GMPs) and complete data in US Food and Drug Administration (FDA) GMPs. Why can’t we have harmonization of terms?

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LCGC Europe

Hamish Small spoke to AndrО Striegel about the secrets of his success in separation science, including the development of ion chromatography, and the value of vague thoughts in scientific progress.