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Successful Tech Transfer to a CMO Depends on a Strong Quality Agreement and Open Communication Pathways, FDA Asserts

Nov 1st, 2013

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A detailed description of how a drug product owner will transfer technical knowledge to a contract manufacturer needs to be part of a quality agreement, FDA officials are stressing.

They are cautioning that openness, in general, by the product owner regarding information learned in product/process development is needed for the transfer to be ultimately successful.

At the PDA/FDA conference in Washington in mid-September, CDER Office of Compliance Division of GMP Assessment Director David Doleski commented on the importance of the technical transfer process and the role the quality agreement plays in assuring its success.

“Quality agreements should indicate that owners of the application – NDAs, ANDAs, BLAs, and non-application products (OTC products) – have a methodology for transfer of the product and process development information from the owner to the contract manufacturer to assure a quality product will be manufactured in conformance with CGMPs,” he maintained.

“It is really important,” Doleski emphasized, “that we maximize the chances of success by transferring all available product and process development information to the contract manufacturer in order to have a successful launch of that product.”

[The story continues for subscribers beginning on page 2.  Included is an FDA case study reported by Doleski in which the GMP and tech transfer problems that can surface in a contracting relationship were writ large.  Nonsubscribers can purchase the story for $195 by contacting Wayne Rhodes ([email protected]).  For subscription/license information, click here.]

See related IPQ story:

Joint Drafting of Contract Manufacturing Quality Agreements Needed to Reflect Shared Quality Ownership, FDA Stresses

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