RAPS: Data Integrity in cGMP Drug Manufacturing: FDA Offers New Draft Guidance

The recent influx of concerns over data manipulation and other data integrity questions in India, China and elsewhere has pushed the US Food and Drug Administration (FDA) to put out new draft guidance on Thursday to help the pharmaceutical industry ensure data is consistent and accurate. The guidance includes 18 questions and answers on data integrity, alongside well-defined terms on data as they relate to current good manufacturing practice (cGMP) records, as well as recommendations on when workflows on computer systems need to be validated, and how to ensure electronic master production and control records (MPCR) are monitored and can only be used by authorized personnel.