Validation of Alternative Microbiology Methods for Product Testing Quantitative and Qualitative Assays

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Article
Pharmaceutical TechnologyPharmaceutical Technology-04-02-2005
Volume 29
Issue 4

The validation of alternative microbiological testing is an opportunity for a manufacturer to decrease the amount of time required for laboratory results.To properly validate these alternatives, a practitioner must first identify what is being studied. The regulatory effect on established product and process specifications and levels must be completely evaluated, as changing the method of analysis may well change the pparent number in the sample.

External Link - article-156877.pdf

Articles in this issue
Analytical Methods Validation In-Process Control Methods for the Manufacture of Active Pharmaceutical Ingredients
April 2005
Management Controls for GMP Compliance
The Sector Chart: A New Engineering Graph for Pharmaceutical Processes
Validation of Alternative Microbiology Methods for Product Testing Quantitative and Qualitative Assays
PAT and Process Understanding: A Call to Arms
Cold Chain Concerns
Evolutions in Direct Compression
X-ray Microtomography of Solid Dosage Forms
Orient Express
Importance of Background Microbial Levels in the Manufacture and Testing of Sterile Products
Using Visible Residue Limits for Introducing New Compounds into a Pharmaceutical Research Facility
Comparative Evaluation of Three Active Air Samplers for the Monitoring of Airborne Microorganisms
Famine in Field Inspection
Establishing Target Fills for Semisolid and Liquid Dosage Forms
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