FDA issues draft guidance on contract manufacturing
pharmafile | June 3, 2013 | News story | Manufacturing and Production | FDA, GMP, Taylor
The US Food and Drug Administration FDA has published draft guidance on quality agreements between pharma companies and contract manufacturers.
Written quality agreements are not currently mandated under US current Good Manufacturing Practice (cGMP) regulations, but the FDA would like to see them used more widely “to delineate … responsibilities and ensure drug quality, safety, and efficacy”.
The document brings the FDA’s official position into line with other guidance, including for example ICH Q7 on GMP for APIs, which advises that drug manufacturers have formal quality agreements in place with suppliers backed up by facility audits.
It also draws on elements of ICH Q9 Quality Risk Management and ICH Q10 Pharmaceutical Quality Systems, says the FDA, which stresses that having an agreement in place is not a substitute for meeting cGMP requirements.
The scope of the guidance covers human and veterinary drugs, some combination products, finished drug products, active pharmaceutical ingredients (APIs) and intermediates, as well as the drug constituents of combination drug/device products.
Among the contract services covered by the draft are formulation, fill-and-finish, chemical synthesis, cell culture and fermentation activities, analytical testing and other laboratory services, as well as packaging and labelling.
Quality agreements should be clear in defining the purpose and scope of the collaboration, set out terms (including the effective date and termination clause), and specify how change control/revisions and disputes are handled, it says.
Elements of the agreement should include contractor responsibilities, with a separate section detailing quality unit responsibilities, and also cover facilities and equipment, materials management, lab controls documentation and any product-specific considerations, notes the draft.
The document also includes a series of case studies illustrating how quality agreements can prevent problems. One example discusses a scenario in which a contracted facility’s batch records do not accurately reflect the actual manufacturing process, with the contractor claiming the incomplete batch records resulted from a request by the product owner.
Comments on the draft can be submitted to the FDA until 29 July.
Phil Taylor
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