Search results for " reliability"
Article
State of Quality and Compliance in the Biopharmaceutical Industry
QUALITY IMPROVEMENT INITIATIVES
PAT, QbD, Quality, and cGMPs for the 21st Century are meant to provide increased understanding, control, and reliability of manufacturing processes, as well as c…
Article
Operational Excellence: More Than Just Process Improvement
However, that approach forgoes the improvements in efficiency, reliability, and the reductions in costs biopharmaceutical organizations can ill afford to sacrifice. And the result of gold plating will…
Article
Regulatory Challenges in the QbD Paradigm
The authors demonstrate how an integrated model is helping to achieve regulatory flexibility. This article is part of a special section on biopharmaceutical trends.
With the dawn of the 2…
Article
The Lifecycle Change of Process Validation and Analytical Testing
In the two years since the publication of FDA's final process validation guidance, how has this new lifecycle approach affected the way the industry performs validation? BioPharm Internati…
Article
A Look Ahead at BioPharma Manufacturing and Regulation
The FDA talks about the changing scope of regulatory science.
Regulatory science underpins innovation and practices in drug manufacturing. The most common definition of r…
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