The objective of performing an audit of data during development is to provide an assessment of the data quality based on a statistically sound data audit sampling plan, as well as a data audit sampling strategy. Table 1 – Examples of data integrity issues referencing actual warning letters Working with Data Integrity in Practice – ALK’s process for auditing data These issues can vary in degree of severity in a spectrum as shown in Figure 1:įigure 1 – Spectrum of data integrity issues pending from minor bad practices to full-blown falsification scandalsĮxamples of actual warning letters containing these categories are given below: When studying warning letters given by regulatory authorities it is evident that the term ‘data integrity’ covers a wide range of issues. WHO Guidance on Good Data and Record Management Practices September 2015 (draft).FDA Guidance for Industry Data Integrity and Compliance with cGMP April 2016 (draft).MHRA GMP Data Integrity Definitions and Guidance for Industry March 2015.EudraLex, Volume 4 Good Manufacturing Practice (Annex 11).A list of relevant available literature is provided below: Today, the regulatory literature has been expanded significantly since the emergence of 21 CFR part 11 giving further guidance in authorities’ interpretation in cGMP requirements and their own guidelines. This announcement has been followed accordingly with data integrity now being a primary inspection focus and with the presence of highly qualified inspectors trained specifically in data integrity. In 2003 ‘Part 11, Electronic Records Electronic Signatures - Scope and Application’ was published followed by an announcement in 2010 of the FDA, stating that the agency will be conducting inspections focusing on 21 CFR Part 11 requirements 3. FDA link (FDA To Conduct Inspections Focusing on 21 CFR 11 (Part 11) requirements relating to human drugs) – Ī common myth is the statement that data integrity is a new requirement of cGMP. Reid, Generic Drug Price Scandal: Too Bitter a Pill for the Drug Price Competition and Patent Term Restoration Act to Swallow, 75 Notre Dame L. Guidance for Industry Part 11, Electronic Records Electronic Signatures - Scope and Application – Ģ. Before that the need to address data integrity issues was illustrated by ‘the generics scandal’ in the 1980s where falsified data was submitted to support drug approvals 2.ġ. Data Integrity has been on the agenda of regulatory authorities since the introduction of 21 CFR Part 11 in 1997 1.
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