Guidance

Good manufacturing practice: data integrity definitions and guidance

Medicines and Healthcare products Regulatory Agency (MHRA) good manufacturing practice data integrity expectations for the pharmaceutical industry.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 23 January 2015
• Last updated: 13 March 2015
  Show all updates

  1. 13 March 2015

     Following high levels of interest in response to the initial publication of this guidance on 23 January 2015, MHRA has responded to questions from stakeholders by providing additional clarifications to the text. Any additional questions for consideration in future revisions should be sent to gmpinspectorate@mhra.gsi.gov.uk

  2. 23 January 2015

     First published.

This publication was withdrawn on 4 April 2018

Updated guidance on GxP Data Integrity was published in March 2018.

Documents

Good manufacturing practice: data integrity definitions

PDF, 682 KB, 16 pages

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Details

This guidance sets out our expectations for data integrity in good manufacturing practice (GMP).

It complements existing EU GMP guidance and should be read in conjunction with national medicines legislation and the GMP standards published in Eudralex volume 4.

This guidance has been revised following stakeholder feedback. You should send any questions or feedback to gmpinspectorate@mhra.gov.uk.