Stakeholders Urge Clarifications in Data Integrity Draft
The Generic Pharmaceutical Association says that it agrees with FDA that data should be reliable and accurate. “Good manufacturing practices must be followed and data integrity is a necessary component of a robust quality system,” it says in commenting on an agency draft guidance on data integrity and compliance with current good manufacturing practice (CGMP). The association asks FDA to clarify if the guidance applies to all laboratories, including research and development where there is no good practice impact, particularly during pre-development. It also says it would be helpful to have a section providing some guidance in case of limitations for software and vendors. There are additional general comments as well as line-by-line specific comments.
In addition to specific comments, Pfizer says that the guidance should be expanded beyond laboratory examples “as they are overly emphasized and the guidance should include manufacturing examples as well.”
In its response, the Parenteral Drug Association (PDA) says that “data integrity concerns go well beyond quality control laboratories because data and metadata are generated in all departments. PDA recommends the scope of this guidance be enlarged to represent the spectrum of issues seen in Warning Letters … and also recommends FDA add a question and answer explaining the concept of data lifecycle for additional clarity.”
Finally, Pharmaceutical Research and Manufacturers of America (PhRMA) says it supports the draft guidance and its use of a question-and-answer format that “will more easily facilitate future necessary revisions as FDA continues to clarify and reinforce its position in regard to data integrity compliance.” PhRMA provides recommendations and asks for clarifications in terms of terms and definitions related to CGMP records; electronic versus paper records; validation of computerized systems and computers systems access; definition, review, and protection of audit trails; use of CGMP data in/for decision-making; CGMP data documentation and storage; data integrity compliance programs; and reporting of data integrity issues and personnel training requirements.
The trade group says the guidance tends to focus heavily on intentional data integrity violations, and should recognize that data integrity applies to more broad instances beyond fraud. It also asks for more examples that are specifically applicable to the manufacturing setting broadly, and not just the laboratory.