FDA has just issued a final report, "Pharmaceutical CGMPs for the 21st century — A Risk-Based Approach."
If you work in an FDA-regulated industry, you should read it.
What it is
This FDA initiative was launched a couple of years ago specifically to review the good manufacturing practices regulations (CGMP) for the drug industry, which have not been updated since 1978. As such, these regulations do not reflect many of the best practices that have been developed since that time, such as use of a risk-based approach and new technologies, such as process analytical technology (PAT), that improve quality but are difficult to implement under the current regulations. The agency felt that the CGMP as a whole needed to be reviewed.
The working groups of this initiative have done a lot of good work, much of which has already been published in various working papers and other documents that can be found on the FDA web site for the CGMP initiative
Electronic records and electronic signatures
Of interest to information systems professionals, the final report describes its review of 21 CFR Part 11, the FDA regulation that governs the use of electronic records and electronic signatures. FDA has already issued new guidance on Part 11, which I described last year
. FDA has been taking public comments on Part 11 earlier this year. The final report indicates that a draft revision of Part 11 itself will be issued for public comment in 2005.
FDA to practice its own preaching
In the final report, there is one section that caught my attention. Under the heading, "Adoption of Quality Systems Model for Agency Operations," it says, in part,
At the outset of the initiative, FDA conveyed its goal of bringing an integrated quality systems orientation to all Agency activities and programs. A specific goal was the development and implementation of a more systematic approach to regulating pharmaceutical quality, as well as more integration and collaboration among the different components of the Agency that are involved in pharmaceutical quality. The Quality Systems Framework Working Group...developed such a model for the CGMP initiative, referencing key recognized external quality and risk management standards....FDA will now be using a quality systems approach to improve the predictability, consistency, integration, and overall effectiveness of our entire regulatory operation. This quality systems model, now incorporated into the FDA Staff Manual Guide, Quality Systems Framework for Internal Activities, defines the essential quality elements to consider as part of any system that controls an internal FDA regulatory activity.
As we all know, part of FDA's mission is to develop and enforce regulations that mandate implementation of quality systems in food, drug, and medical device manufacturing. Therefore, it might come as a surprise that, until now, FDA itself has not had a quality system to govern its own internal operations. So now FDA will practice what it preaches.
I'm guessing there are a lot of industry folks that are thinking, "It's about time."
Barriers to implementing electronic signatures
A quality systems view of 21 CFR Part 11
RFID coming to the pharmaceutical supply chain
Turning software validation into a meaningful exercise
FDA finalizes guidance for 21 CFR Part 11
FDA drops the other shoe on Part 11
FDA signals change in approach to Part 11
Buzzword alert: Part 11 compliance