Boyang Wang of Immortal Dragons explains how FDA's Expedited IND Pilot and QRIs could compress sequential first-in-human steps as China's Decree 818 raises the pace.
News|Articles|May 1, 2004
- Pharmaceutical Technology-05-01-2004
- Volume 2004 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Perspectives on Aseptic Guidance A Critical Review of FDA's 2003 Draft Guidance and a Proposed Alternative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FDA's draft guidance on aseptic processing contains some inherent difficulties, including unrealistic expectations of sterility and microbial quantification, an absence of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.
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Articles in this issue
over 22 years ago
Implementing Total Organic Carbon Analysis for Cleaning Validationover 22 years ago
The Future of Aseptic Processing?An Updateover 22 years ago
Analysis of Environmental Microbiology Data from Cleanroom SamplesAdvertisement
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Mitigating nitrosamine risk requires assessing each product individually, says Bram Baert, Global Head of Regulatory Affairs at Capsugel, and Sandrine Picco, Senior Analytical Specialist on Capsugel's Innovaform Accelerator Team, in this interview with PharmTech.
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