In the cover story of this month's issue of Pharmaceutical Manufacturing--Workforce Training: Embracing the "Necessary Evil"--I quote several industry consultants who suggest that FDA inspectors are taking a much closer looking at worker training issues than they have in the past, which is evidenced by an increase in mentions of training in recent warning letters. "The tea leaves would say it's an issue," says consultant John English, one of those who provided support for the article.
Consultant Michael Gregor concurs, adding that part of the reason that training issues are coming to light is that FDA is taking a much closer look at 21 CFR Part 11 readiness at facilities, which includes documentation of training and electronic signature authorization.
I sent several questions to FDA in this regard, and received the following answers back from spokespersons Karen Mahoney and Ayse Yeaton. While their answers are characteristically innocuous, I feel the last response, that FDA "may propose changes" to cGMPs in order to require training improvements, is very telling:
PhM: Recent warning letters seem to call attention more frequently to situations in which employees are not sufficiently trained, or in which training and qualification documentation is lacking. Would you agree that this is a trend, and if so what accounts for it?
FDA: During our inspections, FDA reviews a firm's Quality Control/Quality Assurance programs including training and conformance to Standard Operating Procedures. While no specific trend has been identified, many GMP deviations are rooted in insufficient employee training and can be prevented by higher GMP awareness at sites. This is especially important in manufacturing operations that are manually intensive.
PhM: It’s my understanding that FDA is sending additional investigators to manufacturing sites to look specifically at 21 CFR Part 11 matters. Is this correct (and true of every investigation), and are electronic records of worker credentials and signature authorizations a top priority for these investigators?
FDA: FDA will be conducting a number of inspections that will evaluate conformance with 21 CFR 11 (Part 11) requirements and related predicate rules. CDER will review all inspection findings to determine each site's conformance with existing Part 11 and predicate rules. CDER will also consider the inspectional findings in assessing the need for revisions to our Part 11 program.
PhM: The Agency has made it known that it expects drug manufacturers to establish greater oversight of their vendor and contract partners. I assume this would include greater oversight of the training and credentials of key staff at those partners. Does the Agency anticipate updating GMP’s to reflect this, and has any concrete plan or timeline been established?
FDA: A drug manufacturer/application holder must ensure that its vendors and contractors meet GMPs, including the quality standards of the drug manufacturer who is their business partner. FDA is reevaluating the CGMP regulations and may propose changes that will require training program improvements.
Workforce training is an issue that figures to stay with us as long as the industry continues to downsize its workforces, and as long as glaring quality issues continue to make headlines. As English mentions in my article, manufacturers must gauge whether training is really the problem, or if it's being used as a panacea for deeper issues within the organization.
--Paul Thomas
