Part 5 — The Cost of Getting a Technology Transfer Right

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 5 of an in-depth, multi-part series on tech transfer.  Visit our blog page to view additional segments.]

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Topics: Regulatory site audit, legal fees, capital expenditure, MSA, QA, confirmation/demonstration batch

Implementing a Change Control Process - Part 2

Posted by Anelis Aurand-Araos

At WellSpring, as with any other pharmaceutical manufacturing company, we developed a change control policy to ensure that any proposed changes to product or processes were thoroughly examined before they were implemented, and that no unintended consequences would result. As we are currently reviewing and updating our policy, we felt that sharing our methodology would be illustrative of our process and instructive to others who need better processes. 

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Topics: Change control process, change management, change control committee, QA