GAMP Americas Forum generates audience participation

The Food and Drug Administration’s 21 CFR 11 regulations and guidance on electronic records and signatures are being rewritten, confirmed Robert Tollefsen, consumer safety officer with the FDA.

He believed a draft would be made available for comment by the end of the year, though its release date is uncertain.

Tollefsen’s remarks came as a response to an audience member question during an active panel discussion at ISPE’s GAMP Americas Forum held August 22 in Itasca, IL. ISPE, the International Society for Pharmaceutical Engineers, includes nearly 23ꯠ pharmaceutical manufacturing professionals in 80 countries. The GAMP (Good Automated Manufacturing Practice) Forum is an ISPE subcommittee; it’s mission is to promote understanding of the regulation and use of automated systems within healthcare industries, including those used in packaging.

Among the intelligence from the event were the following:

  • “More than 40 percent of software fails to meet user requirements,” said Steven Coates, director/computer QA at Wyeth.

  • When gaining “buy-in” from Information Technology on computer compliance, “real-life benefits are more meaningful to IT than FDA ‘sabre-rattling,’” noted Barbara Mullendore, director of corporate quality systems for Watson Pharmaceuticals.

  • “If you think computer compliance is a challenge,” said Robert Herr, manager, regulatory and quality for Pfizer’s Animal Health Business Technology, wait until security. “It’s the next big business.”

  • Michael Rutherford, manager of global quality labs at Eli Lilly & Co., said, “training is something industry doesn’t take enough time on. It’s expensive, and just when an employee is properly trained, there’s turnover.” He said a good employee requires a blend of on-the-job experience, training, and education. “Just giving them a template of what to do doesn’t mean they’ll know what they’re doing. A fool with a tool is still a fool.”

  • Tollefsen agreed with Herr that Quality Assurance should be involved from the outset when it comes to automated computer systems and pharmaceutical validation processes.

  • Tollefsen, who audits pharmaceutical facilities, said “the FDA looks to organizations like ISPE to supply standards for automated systems. We don’t necessarily endorse any one system.”

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