New eBook: Managing Risk and Ensuring Success With a Contract Manufacturing Partner

Posted by Wellspring Pharma Services

Any long-term commercial relationship, especially between a drug innovator and its CMO, requires a number of things to remain sound: ongoing dialogue, common expectations, milestones and metrics, responsiveness, secure data access and more. With time, these relational and transactional exchanges build a collaborative bridge that pushes risk out and business success into these highly technical and complex relationships.

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Topics: E-Book, confirmation/demonstration batch, qualification, Process Development, best practices, pharmaceutical manufacturing

Part 7 — How Does the FDA's Process Validation Guidance Simplify a Technology Transfer?

Posted by Norm Fong

Technology Transfer: Want To Get It Right? 

[Editor’s note: Success in contract pharmaceutical manufacturing hinges on several critical factors, but chief among them is getting technology transfer right. This is part 7 of an in-depth, multi-part series on tech transfer.  Visit our blog page to view additional segments.]

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Topics: qualification, PV, process validation, IQ, FDA guidance, OQ, PQ