FDA finalizes quality guidelines for contract manufacturers | BioPharma Dive

Read the full article: FDA finalizes quality guidelines for contract manufacturers | BioPharma Dive:

"In its 16-page document, FDA also explains that Current Good Manufacturing Practice (CGMP) requirements apply to all contract facilities, including analytical testing labs."

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View the published guidance document:
Contract Manufacturing Arrangements for Drugs: Quality Agreements - FDA Guidance for Industry (PDF)

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FDA : Draft Guidance - Contract Manufacturing Arrangements for Drugs: Quality Agreements; Availability

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Comments are due to FDA by July 29, 2013.

Federal Register | Draft Guidance for Industry on Contract Manufacturing Arrangements for Drugs: Quality Agreements; Availability:

"This guidance describes our current thinking on defining, establishing, and documenting the responsibilities of each party (or all parties) involved in the contract manufacturing of drugs subject to Current Good Manufacturing Practice (CGMP). In particular, we describe how parties involved in the contract manufacturing of drugs can utilize Quality Agreements to delineate their responsibilities and assure drug quality, safety, and efficacy."

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