WHO TRS (Technical Report Series) 1033, 2021 Annex 4

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WHO TRS (Technical Report Series) 1033, 2021 Annex 4

Guideline on data integrity

This document replaces the WHO Guidance on good data and record management practices (Annex 5, WHO Technical Report Series, No. 996, 2016) (1).

1. Introduction and background:

1.1. In recent years, the number of observations made regarding the integrity of data, documentation and record management practices during inspections of good manufacturing practice (GMP) (2), good clinical practice (GCP), good laboratory practice (GLP) and Good Trade and Distribution Practices (GTDP) have been increasing. The possible causes for this may include (i) reliance on inadequate human practices; (ii) poorly defined procedures; (iii) resource constraints; (iv) the use of computerized systems that are not capable of meeting regulatory requirements or are inappropriately managed and validated (3, 4); (v) inappropriate and inadequate control of data flow; and (vi) failure to adequately review and manage original data and records.

1.2. Data governance and related measures should be part of a quality system, and are important to ensure the reliability of data and records in good practice (GxP) activities and regulatory submissions. The data and records should be ‘attributable, legible, contemporaneous, original’ and accurate, complete, consistent, enduring, and available; commonly referred to as “ALCOA+”.

1.3. This document replaces the WHO Guidance on good data and record management practices (Annex 5, WHO Technical Report Series, No. 996, 2016) (1).

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WHO TRS (Technical Report Series) 1033, 2021 Annex 4:
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