Medicines, medical devices and blood regulation and safety – guidance

Good manufacturing practice: data integrity definitions

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

Document: Revision 1.1 (https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/412735/Data_integrity_definitions_and_guidance_v2.pdf)

Detail

This guidance sets out MHRA’s 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.gsi.gov.uk.

Reason for Changes

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.