In response to increased current good manufacturing practice ("CGMP") violations involving data integrity, FDA recently released a draft guidance titled "Data Integrity and Compliance With CGMP." Structured in question-and-answer format, the draft guidance addresses specific questions on how data integrity relates to CGMP for drugs and provides guidance on more general data integrity concepts. FDA previously published parts of the draft guidance on its webpage titled "Questions and Answers on Current Good Manufacturing Practices, Good Guidance Practices, Level 2 Guidance—Records and Reports." Once finalized, the draft guidance will replace the previous online guidance on data integrity in CGMP.
The FDA draft guidance follows on the heels of data integrity guidance published by the UK's Medicines and Healthcare Products Regulatory Agency in March 2015 and draft guidance published by the World Health Organization in September 2015. FDA is requesting comments on the draft guidance by June 14, 2016
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
