Guidance on good data and record management practices

Background:

During an informal consultation on inspection, good manufacturing practices and risk management guidance in medicines’ manufacturing held by the World Health Organization (WHO) in Geneva in April 2014, a proposal for new guidance on good data management was discussed and its development recommended. The participants included national inspectors and specialists in the various agenda topics, as well as staff of the Prequalification Team (PQT)–Inspections.

The WHO Expert Committee on Specifications for Pharmaceutical Preparations received feedback from this informal consultation during its forty-ninth meeting in October 2014. A concept paper was received from PQT–Inspections describing the proposed structure of a new guidance document, which was discussed in detail. The concept paper consolidated existing normative principles and gave some illustrative examples of their implementation. In the Appendix to the concept paper, extracts from existing good practices and guidance documents were combined to illustrate the current relevant guidance on assuring the reliability of data and related GXP (good (anything) practice) matters. In view of the increasing number of observations made during inspections that relate to data management practices, the Committee endorsed the proposal.

Following this endorsement, a draft document was prepared by members of PQT–Inspection and a drafting group, including national inspectors. This draft was discussed at a consultation on data management, bioequivalence, good manufacturing practices and medicines’ inspection held from 29 June to 1 July 2015.

A revised draft document was subsequently prepared by the authors in collaboration with the drafting group, based on the feedback received during this consultation, and the subsequent WHO workshop on data management.

Collaboration is being sought with other organizations towards future convergence in this area.

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Table of Contents

1. Introduction

2. Aims and objectives of this guidance

3. Glossary

4. Principles

5. Quality risk management to ensure good data management

6. Management governance and quality audits

7. Contracted organizations, suppliers and service providers

8. Training in good data and record management

9. Good documentation practices