Using S88 to define a compliant package environment

Moin Hussein, McNeil/Johnson and Johnson; Ron Williams, EnteGreat Inc. Hussein: We needed a paradigm change to eliminate sources of non-compliance within the manufacturing environment. So we came up with a new set of integrated capabilities that both control manufacturing processes and collect detailed information o those processes to enable a platform for continuous improvement programs.. We developed a framework that aligns to McNeil's key business drivers: Compliance Cost Commercialization Customer Service Compliant Manufacturing is an operating environment that is focused on error proofing cGMP manufacturing and quality activities to eliminate sources on non-compliance. Ron Williams went through the way his company, EnteGreat met the McNeil requirements for a Compliant Manufacturing Suite. You'll be able to see these presentations in the next week or so by visiting and clicking through the WBF Body of Knowledge icon. We'll be posting all of the presentations from WBF North America 2007 just as soon as we get back with the CD. "Everyone knows how well ISA-88 works for batch processing," Williams said, "but it also is an excellent fit for packaging!" ISA-88 can provide the overarching framework to define and sustain a compliant packaging environment, from Process Definition through Governance.