Not Always From the Top Down

Manufacturing operators key to quality culture

By Susan Kheen, Contributing Editor

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If your organization decides to embark on an operator training program, then consider this: Quality training consistency across geographic borders and between a company’s multiple sites is important. With 90% of the medicines people ingest produced generically and 70% of those medicines also produced overseas², make sure the training you provide is consistent across your global organization, and it is available in multiple languages. Again, this sounds obvious, but your competitive advantage is lost if the cGMP education is only available in English. A CMO who can show a Web-based training program for its operators across its global organization with access to multiple languages will have a competitive advantage in the marketplace.

Increased levels of scrutiny will be felt inside organizations. FDA’s Woodcock made no secret of the fact that she is dedicating higher levels of funding to the effort of audits and is increasing staff. However, FDA is also quite clearly on a path to conduct more risk-based audits, as it has been mandated to do under FDA Safety and Innovation Act (FDASIA). There have been multiple meetings with industry to define the quality metrics necessary for consistent measurement of a risk based approach to measuring an organization’s quality culture. While there is an ongoing debate on how to define a consistent measurement of company risk profiles, there seems little doubt that more frequent audits will be the result for those who have the poorest quality rankings. If a quality culture can be clearly demonstrated, at all levels of an organization — from the operators who manufacture the drugs and devices at the shop floor and throughout all levels of an organization, one of the FDA rewards will be less frequent audits, because a manufacturing organization would have a lower risk profile than its peers.

Fewer audits mean measurable cost savings to an organization; just the cost difference between bi-annual audits and annual or multi-annual FDA audits alone is substantial. In addition, higher quality can mean commanding a better price in the market for a CMO’s products. For a CMO, going back to re-negotiate a contract with a client pharmaceutical company there is no question that their bargaining position will be stronger if the CMO organization has taken a proactive role in continuous quality improvement: developing, measuring and communicating their quality culture with its pool of potential clients. At the ISPE annual meeting last year one of the papers quantified a 15% cost saving from increasing product quality. So, while it may take investment up front, there are excellent commercial, market and operational reasons to consider investment in quality improvement and culture across all levels of your manufacturing organization.

Operator training is certainly not the only answer to enhancing an existing quality culture. But it is one that clearly deserves attention, based on recent FDA-speak, that they are re-focusing on manufacturing and cGMPs. Commercially, there are clear reasons to become an early adopter and invest in operator learning. In short, focus on your manufacturing floor, because FDA is focusing there, in a big way. If you head up a CMO or are the VP Manufacturing for a company using CMOs, begin a discussion today about how to institute, measure and demonstrate a learning program that encourages shop floor operators to go beyond the SOPs, to truly understand the Whys of cGMP.


1 Food Safety News Obama Administration Seeks FDA Funding Increase for FSMA Implementation by Helena Bottemiller, April 11, 2013
2 Janet Woodcock plenary speech, ISPE Annual Meeting, Washington, D.C., November 2013.


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