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Rapid Methods Validation

Validation packages for RMMs should include the following:

Description of the technique, including application principle

  • Information should be compiled from the supplier and the end-user *
  • Technology should be described in a peer-reviewed journal

Primary validation (EP 5.1.6) *

  • Exposes the new technology to microorganisms
  • Testing can be performed by the vendor
  • Adequate justifications for any deviations from guidelines

Risk benefit analysis *

  • Includes comparison of risks to traditional method and includes weaknesses of new method

Validation of equipment (DQ, IQ, OQ) *

Comparative study against pharmacopoeial/traditional method (PQ)

  • Side-by-side testing performed with actual drug product
    • Must be at least equivalent to traditional method
    • Should include metabolically and physically injured cells

Quality Expert Report by a suitably qualified individual (include CV) *

  • Explain strategy for implementation and how identification will be addressed
  • To determine appropriate statistical tools and processes, statisticians will be needed.  Explain tools used and why.
  • Explain changes in limits if applicable


*Areas where BioVigilant can contribute