GMPs/Validation Resources - BioPharm International

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GMPs/Validation Resources
Articles, references, and other tools to assist facilities in developing and maintaining good manufacturing practices.

Building Blocks of Quality by Design | IVT

September 6, 2013

This is the first of a monthly series of short commentaries on the use of QbD in the pharma and biotech industries.

Analytical methods and QbD: A Perfect Match | IVT

September 6, 2013

Take the long view of analytical methods and continue to build a strong knowledge base for them; to learn from history and improve their quality at every opportunity.

Improvement Alphabet: QbD, PAT, LSS, DOE, SPC?How Do They Fit Together? | IVT

September 6, 2013

Consider the following scenario, a new pharmaceutical or biotech scientist or engineer is assigned the job of solving a problem, improving a process, or just developing better understanding how a process works. Five different people are asked for advice and guidance, and five different recommendations are received and summarized as ? QbD, PAT, LSS, DOE, and SPC.

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