Practical Risk-Based Guide for Managing Data Integrity
1 ACTIVE PHARMACEUTICAL INGREDIENTS COMMITTEE Practical risk-based guide for managing data integrity Version 1, March 2019 2 PREAMBLE This original version of this guidance document has been compiled by a subdivision of the APIC Data Integrity Task Force on behalf of the Active Pharmaceutical Ingredient Committee (APIC) of CEFIC. The Task Force members are: Charles Gibbons, AbbVie, Ireland Danny De Scheemaecker, Janssen Pharmaceutica NV Rob De Proost, Janssen Pharmaceutica NV Dieter Vanderlinden, S.A. Ajinomoto Omnichem N.V. André van der Biezen, Aspen Oss B.V. Sebastian Fuchs, Tereos Daniel Davies, Lonza AG Fraser Strachan, DSM Bjorn Van Krevelen, Janssen Pharmaceutica NV Alessandro Fava, F.I.S. (Fabbrica Italiana Sintetici) SpA Alexandra Silva, Hovione FarmaCiencia SA Nicola Martone, DSM Sinochem Pharmaceuticals Ulrich-Andreas Opitz, Merck KGaA Dominique Rasewsky, Merck KGaA With support and review from: Pieter van der Hoeven, APIC, Belgium Francois Vandeweyer, Janssen Pharmaceutica NV Annick Bonneure, APIC, Belgium The APIC Quality Working Group 3 1 Contents 1. General Section .............................................................................................................................. 4 1.1 Introduction ............................................................................................................................ 4 1.2 Objectives and Scope .............................................................................................................. 5 1.3 Definitions and abbreviations ................................................................................................
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