Perspectives on Aseptic Guidance A Critical Review of FDA's 2003 Draft Guidance and a Proposed Alternative

James P. Agalloco;

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Article

May 1, 2004

Pharmaceutical Technology

Pharmaceutical Technology-05-01-2004

Volume2004 Supplement

Issue 3

Perspectives on Aseptic Guidance A Critical Review of FDA's 2003 Draft Guidance and a Proposed Alternative

Author(s):

James P. Agalloco

FDA's draft guidance on aseptic processing contains some inherent difficulties, including unrealistic expectations of sterility and microbial quantification, an absence of harmonization with international rules, and failure to support new technologies or a risk-based approach. The authors propose a science-based alternative.

External Link - article-94604.pdf

Articles in this issue

Implementing Total Organic Carbon Analysis for Cleaning Validation

Perspectives on Aseptic Guidance A Critical Review of FDA's 2003 Draft Guidance and a Proposed Alternative

The Future of Aseptic Processing?An Update

Analysis of Environmental Microbiology Data from Cleanroom Samples

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