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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 firstname.lastname@example.org.
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 email@example.com