By Razan Jammal, Global Product Manager Instrumentation, Pall Corporation
The most recent guidance documents from the US Food and Drug Administration (FDA) and the British Medicines & Healthcare Products Regulatory Agency (MHRA) regarding the data integrity of electronic records were issued in 2018. Other agencies like the European Medicine Agency (EMA) issued similar guidelines. The National Institute of Standards and Technology, meanwhile, published updated digital identification guidelines in 2017.
The FDA document on ‘data integrity and compliance with drug cGMP’ is in question-and-answer format designed to clarify the role of data integrity in current good manufacturing practice (cGMP) for drugs as required in 21 CFR Parts 210, 211, and 212. This document was issued because the agency was finding noncompliance at many pharma companies, including large, established firms.
Despite the guidance the FDA continues to uncover data integrity compliance problems, as reflected by the number of warning letters issued in the last two years. Clearly many drug manufacturers - and potentially equipment vendors - remain not fully aware of the regulatory requirements around electronic records and signatures.
Assuring the integrity of records when generating and maintaining them is essential to the development and production of high-quality, safe, and effective drugs and as digital technologies have advanced, regulatory requirements regarding data integrity have also evolved.