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. Nicola Martone, DSM Sinochem Pharmaceuticals Ulrich-Andreas Opitz, Merck KGaA.
Data severity assessment: within GxP data, different levels of severity can be defined as a function of its use. Typically, this is linked to the stage of manufacturing following the principle of increasing GxP outlined in ICH Q7. Alternatively, other factors such as impact on final product quality can be taken into account to further
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