Thursday, 18 August 2016

Data Integrity: New guidance now available on EMA’s website

The European Medicines Agency (EMA) has released new good manufacturing practice (GMP) guidance to ensure the integrity of data that are generated in the process of testing, manufacturing, packaging, distribution and monitoring of medicines.

The guidance consists of 23 questions and answers which cover a range of topics within data integrity, including aspects of the data lifecycle and associated risks, and a table which provides the link between each ALCOA principle and the existing EU GMP published in Eudralex Chapter 4 (this may be very useful for auditors new to data integrity).

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