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

Document: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/397853/Data_integrity_definitions_and_expectations_v3_4__ack.pdf

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.