By Ed Silverman // May 18th, 2010// 8:27 am
In a bid to evaluate the pharmaceutical industry’s compliance with a regulation known as 21 CFR Part 11, which is all about the growing and vast use of electronic records, the FDA is about to begin a series of so-called inspectional findings at many drugmakers. The precise timing and number of facilities to be audited - and these are audits, in effect - has yet to be determined, but they will be conducted by the FDA’s Center for Drug Evaluation and Research, or CDER.
“CDER intends to use the inspectional findings to help assess how to proceed with regard to the possible modification of Part 11. CDER intends to take appropriate action to enforce Part 11 requirements for issues raised during the inspections” Robert Tollefsen, a consumer safety officer and national expert on computers at the FDA’s division of field investigations, wrote us in an email. Word of the audits began circulating after he made a recent presentation to an industry group.
The move comes after more than a decade of back-and-forth deliberating by the agency as it seeks to firm up rules for the use of electronic technology for a host of activities, such as gathering info from clinical trials and manufacturing. Back in 1997, the FDA issued final regs providing criteria and promising guidance that were subsequently issued in 2001 and then updatedin 2003, but then withdrawn over various industry concerns, such as restricting usage and innovation and increasing the cost of compliance. Meanwhile, a planned revision has yet to appear.
Speaking of costs, these planned ‘inspectional findings’ are likely to make the exercise still more expensive, as drugmakers labor to demonstrate that they are using techology as the FDA has envisioned. Of course, this will turn into a field day for consultants, since what has become a long-running undertaking shows no sign of coming to a conclusion any time soon. For more what of Tollefsen had to say, please keep reading…
“The timeframes for this CDER effort to begin have not yet been determined but CDER wants it implemented and completed soon. At this point no other FDA Centers are involved but they have been informed of CDER’s efforts and they will be monitoring CDER’s findings,” Tollefsen also wrote. “Thomas Arista, National Expert FDA/ORA/ORO/Division of Field Investigations, and I are currently working with CDER to sort out some specific details for the assignment before it gets finalized and rolled out to our field operations.
“The approach currently planned is that as routine inspections are conducted by the FDA Districts for selected CDER program areas (which may include GMP’s, GLP’s or GCP’s) that CDER would send out as a ‘tag along’ the Part 11 assignment to be added to the routine inspection assignments. Any inspections of Part 11 systems are to be conducted consistent with FDA’s Scope & Application Guidance and as such any Part 11 systems covered might otherwise have been covered anyway as part of a routine FDA inspection. The exact number of such Part 11 assignments to be sent out and the specific firms/CDER program areas to be included will be decided by CDER.”
http://www.pharmalot.com/2010/05/fda-to-audit-pharmas-electronic-recordkeeping/
