Good manufacturing practice: data integrity definitions and guidance
- Medicines and Healthcare products Regulatory Agency
- Part of:
- Patient safety and Good practice, inspections and enforcement
- First published:
- 23 January 2015
- Last updated:
- 13 March 2015, see all updates
Medicines and Healthcare products Regulatory Agency (MHRA) good manufacturing practice data integrity expectations for the pharmaceutical industry.
PDF, 237KB, 16 pages
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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 email@example.com.
Published: 23 January 2015
Updated: 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 firstname.lastname@example.org
- First published.