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by Alan Alper, MA Editorial Staff Posted on Friday, July 29, 2005 1:00:00 PM   | Abstract: | Here are some tips and resources for keeping pace with evolving FDA requirements |
On the books since the late 1990s, Title 21, Code of Federal Regulations, Part 11 (21 CFR Part 11) established criteria under which electronic records and signatures are now considered equivalent to paper records and handwritten signatures in validating manufacturing processes regulated by the Federal Drug Administration (FDA). But the regulation, which was vigorously policed by the FDA initially to ensure that process manufacturers using e-signatures can document "good" manufacturing processes (i.e., safe ingredients, as well as proper assembly, packaging and handling procedures) is for the most part now left to the industry to self administer, analysts say. The requirement for e-signatures, archiving and record retention in 21 CFR Part 11 was an outgrowth of the FDA's Good Manufacturing Practices (cGMP regulations). But as political winds in Washington, D.C have shifted, the FDA is using Part 11 compliance to help propel business process enhancements that result in improved manufacturing productivity. The FDA's focus is to ensure that manufacturers are in control of their operations, making them more accountable to enforce the cGPM regulations, which in the past have resulted in heavy fines levied through consent decrees (see what "http://www.managingautomation.com/maonline/magazine/read/3522" target="_blank"> non-compliance cost Abbott Laboratories and Schering-Plough a few years ago). By following the good manufacturing practices that Part 11 reinforces, the FDA wants manufacturers to use "control process analytics to keep tight reign on their production processes. In this vein, the government is positioning Part 11 compliance as way for manufacturers to assemble the technological wherewithal to detect product integrity and information security problems before goods enter the market and impact consumer safety -- not to mention the manufacturer's bottom line and reputation, analysts suggest. "They've instituted idea of risk-based compliance instead of FDA policing ... digging under the covers and looking in every nook and cranny," is no longer the modus operandi, notes Roddy Martin, a vice president at AMR Research, Inc. (Boston). "[Manufacturers] must be able to demonstrate that [they] are in control of their processes." Manufacturers shown not be in control of their processes will be investigated by the FDA, he adds. "They are not going in with an army of inspectors to start with -- they don't have the resources to play that policing role -- they are focused on those companies that are battling with their processes," Martin points out. Staying within the FDA's guidelines often comes down to adopting a science-based, secure and auditable approach to measuring and documenting all activities to ensure that production processes meet federal standards, Martin says. This approach has played well among pharmaceuticals companies, which have embraced Part 11 in the name of reduced paperwork; food and beverage producers and other process manufacturers have been slower to move forward, he notes. "Ten to 20% of the [pharmaceuticals] industry has been successful in moving to a paperless environment," Martin estimates. This is driven by the paperwork needed to receive FDA approval to market new drugs. Such applications, in some cases, can entail "four FedEx truck loads of data," to get the process started, Martin notes, citing the cost advantage of shipping CDs with electronic files. "Pharma is already approaching it, at least the progressive [companies]," agrees John Blanchard of ARC Advisory Group (Dedham, MA). "The food industry isn't doing anything -- why should they if there is no enforcement." Page : 12 ... NEXT |