Validation Study of Rapid Assays of Bioburden, Endotoxins and Other Contamination

Author:

SHINTANI HIDEHARU1

Affiliation:

1. Chuo University, Department of Science and Engineering

Publisher

The Society for Antibacterial and Antifungal Agents, Japan

Subject

Public Health, Environmental and Occupational Health,Applied Microbiology and Biotechnology

Reference11 articles.

1. CPMP/QWP/486/95 (1996) Note for Guidance on Manufacture of the Finished Dosage Form.

2. Cundell, A. M. (2004) Microbial testing in support of aseptic processing. Pharm. Technol., 56-66.

3. Cundell, A. M. (2005) Risk-Based Approach to Pharmaceutical Microbiology. In Encyclopedia w of Rapid Microbiological Methods. Miller MJ, ed, Bethesda, MD: Davis Horwood/PDA.

4. European Pharmacopoeia 5.1.6. Alternative Methods for Control of Microbiological Quality. European Directorate for the Quality of Medicines, Strasbourg, France.

5. FDA (2003) Draft Guidance for Industry-Comparability Protocols-Chemistry. Manufacturing and Controls Information, Department of Health and Human Services, U. S. Food and Drug Administration.

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