FDA tightens pharma’s responsibility for outsourcing
pharmafile | June 22, 2010 | News story | Manufacturing and Production | FDA, GMP, manufacturing, outsourcing
Pharmaceutical manufacturers will be held more responsible for the activities of their suppliers and outsourcing partners under a new approach being considered by the FDA.
Brian Hasselbalch of the US regulator’s division of manufacturing and product quality told delegates at the Xavier Global Outsourcing conference in Cincinnati, Ohio, last week that drugmakers must be more stringent in their oversight of contract manufacturers.
He cited FDA figures which indicate that in fiscal 2007 the agency sent warning letters to two CMOs and four sponsor companies. By June of fiscal 2010 the tally stands at 15 warning letters for CMOs, and four for sponsors.
One of the options under consideration is to insist manufacturing authorisation holders carry out on-site audits – either themselves or via third-party auditors – rather than relying on a certification approach based on a review of documentation. And where defects are found at a CMO, a warning letter could also be sent to the sponsor company, he suggested.
The agency is working on a quality agreement template to help guide the business relationship between sponsors and contractors and provide guidance on what is expected from both parties.
‘Two for one’ regulatory actions
Kathleen Culver of the Cincinnati branch of the FDA echoed Hasselbalch’s comments on warning letters in her presentation, suggesting that where an FDA inspection reveals that a contract manufacturer is deviating from GMP, it is also the responsibility of the marketing authorisation holder, as both should ensure the product is made to legal specification.
“If the contract manufacturing site gets a warning letter because the drug product is adulterated or misbranded, shouldn’t the sponsor also be held accountable by FDA?” she asked the conference.
Drugmakers should be prepared to share the relevant sections of the approval dossiers with CMOs to help them comply with the legal requirements, while in turn CMOs should be prepared to allow sponsors to share audit information.
The proposal comes at a time when some sections of the industry – spearheaded by the Rx-360 group – are trying to push forward a system of shared audits in order to alleviate the burden of audits and inspections and achieve an increase in quality standards.
GMP changes
The FDA is also drawing up changes to the 21 CFR Part 211 legislation on Good Manufacturing Practice (GMP) to bring in new requirements on corporate responsibility as well as the control of raw materials.
In particular, it will ask that manufacturers maintain clear visibility over the supply chains for ingredients and components used in their products. Manufacturers will also have to notify the FDA promptly of any cases in which raw materials used in medicinal products have serious defects, so that the agency can move more quickly to warn other users of the material and get it removed from distribution.
Hasselbalch noted that the number of sites supplying the US pharmaceuticals market is on the rise, with more than 80% of all active pharmaceutical ingredients, for example, sourced from overseas.
Phil Taylor
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