By R.D. McDowall, Chris Burgess - LCGC Europe, Aug 12, 2015
"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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