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Pharmaceutical Technology-05-01-2003

home / journals / pharmaceutical-technology / pharmaceutical-technology-05-01-2003

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The PQRI Aseptic Processing Working Group: What was it? What Did It Cover? What Conclusions Did It Reach? Why Was It Important?

Glenn E. Wright
May 1st 2003
ArticleArticle

Members of FDA, industry, and academia formed a working group within PQRI to openly discuss topics from a scientific perspective and provide formalized clarifications and recommendations to FDA to be considered and incorporated into FDA's draft guidance on aseptic processing.


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FDA Perspectives: Revising the 1987 Industry Guideline The Development of FDA's Guidance on Aseptic Processing

Richard L. Friedman
May 1st 2003
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The authors describe the solicitation of industry input for the guidance through a process that included a 2002 meeting of the Advisory Committe on Pharmaceutical Science and the subsequent formation of the PQRI Aseptic Processing Working Group.


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Training for Aseptic Processing Environments

Anne Marie Dixon-Heathman
May 1st 2003
ArticleArticle

Training for aseptic processing cleanrooms must be a dynamic process to meet job requirements and industry demands. The author discusses various approaches that may be taken to ensure a successful training session.

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