BioPharm International - November 2022

BioPharm International - November 2022

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24 BioPharm International ® Manufacturing and Facilities 2022 eBook A udit trail review (ATR) is a mechanism to detect potential critical changes to data/ system security settings and to ensure the quality and integrity of reported data. The authors have defined a risk-based approach to ATR where ATR is only required for high impact GxP (good manufacturing practices [GMP] and good labo- ratory practices [GLP] for the purposes of this paper) analytical data and possible system security chang- es. This approach requires a fully documented risk assessment that encompasses the technical controls and identification of data impact. Note that while an- alytical data are the focus of this paper, the principles outlined may be applied to other activities. Regulatory expectations Data integrity, particularly electronic data integrity, has become an area of increased regulatory focus. Per FDA, "For purposes of this guidance, audit trail means a secure, computer-generated, time-stamped electronic record that allows for reconstruction of the course of events relating to the creation, modification, or deletion of an electronic record" (1). I n 2018, t he Un ite d K i n gdom's Me d ic i ne s & Healthcare products Regulator y Agency (MHR A) and the US FDA issued guidance documents on the topic. MHR A's 'GX P ' Data Integr it y Guidance and Definitions was issued in March 2018. FDA's Data In- tegrity and Compliance with Drug CGMP—Questions and Answers was issued in December 2018. These documents join guidance issued by the World Health Organization (Guideline on Data Integrity) and the Phar- maceutical Inspection Convention Pharmaceutical In- spection Co-operation Scheme (PIC/S, Good Practices for Data Management and Integrity in Regulated GMP/ GDP Environments) (1–4). The publication of these guidance documents is as- sociated with enforcement actions with an emphasis on data integrity that stem from a failure to follow cur- rent good manufacturing practices (CGMPs) predicate A Harmonized Approach to Performing a Risk-Based Audit Trail Review Julie Lippke* and Joseph Mongillo both work in Analytical Research and Development at Pfizer Inc. (Groton, CT); Thomas Cullen and Christian Metz both work in Analytical Research and Development at AbbVie Inc. (North Chicago, IL and Ludwigshafen, Germany, respectively); Katria Harasewych works in Computer System Validation Quality, CoE at Merck & Co., Inc., (West Point, PA); Fouad Benamira works in Analytical Development Sciences for Biologicals at UCB S.A. Belgium. All contributors are part of the IQ Working Group. *To whom all correspondence should be addressed. The IQ Working Group has defined a pragmatic risk-based approach to audit trail review, where it is only required for high impact GxP data. PARRADEE - STOCK.ADOBE.COM

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