Technical / White Paper

Rapid Microbiology Conforms with Regulations Saving Time & Money

Format: PDF file | Document type: Technical / White Paper

Rapid Microbiology Conforms with Regulations Saving Time & Money

The enacted cGMP regulations require manufacturers to ensure that products are free of contamination by objectionable microorganisms, and appropriate microbiological testing is carried out. Rapid microbiological methods (RMM’s) offer a high degree of automation, significant reduction in time to results, reduced staff training, faster product release, and improved process control. However, such methods must achieve 3 objectives: (i) comply with FDA cGMP regulations; (ii) be validated against the standard USP methodology; and (iii) ensure a swift return on investment. This paper describes how to achieve the three objectives while gaining all the benefits of RMM.

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