Transcription of Practical risk-based guide for managing data integrity
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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, Ajinomoto Omnichem Andr van der Biezen, Aspen Oss Sebastian Fuchs, Tereos Daniel Davies, Lonza AG. Fraser Strachan, DSM. Bjorn Van Krevelen, Janssen Pharmaceutica NV. Alessandro Fava, (Fabbrica Italiana Sintetici) SpA. Alexandra Silva, Hovione FarmaCiencia SA.
Assign GxP data to a specific category based on a . severity assessment (refer to section 4.1) Create a . profile. of each . system. based on the way GxP data is handled by that system (e.g. data generation, storage, processing, transfer or a combination thereof) and assign a category to the system based on its profile; (refer to section 4.2)
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