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Pharmaceutical Technology-09-01-2006

home / journals / pharmaceutical-technology / pharmaceutical-technology-09-01-2006

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Out-of-Specification Results and the Quality System Approach to GMPs

September 1st 2006
ArticleArticle

Implementing an electronic system to track out-of-specification results could help ensure compliance with current good manufacturing practices, but the system must be 21 CFR Part 11 compliant and easy to install, maintain, and use.


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Myths, Fantasies, and Rumors about Water System Design

September 1st 2006
ArticleArticle

Water systems require a commonsense approach and good engineering rather than unquestioned acceptance.


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From Quality by Inspection to Quality by Design: A Roadmap for Success

Heather E. Fraser
September 1st 2006
ArticleArticle

Companies must create a risk-based framework for developing and manufacturing drugs, and acquire the scientific knowledge and technological skills to create more complex products.


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Supporting GMPs During the Product Life Cycle in Contract Manufacturing

September 1st 2006
ArticleArticle

A contract manufacturing organization must clearly identify the goals of a project, establish a plan, and then effectively execute accordingly.

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