[December 07, 2017]

Validation, Verification and Transfer of Analytical Methods Seminar Materials: Understanding and implementing guidelines from FDA/EMA, USP and ICH - Research and Markets

The "Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH) - Seminar Materials" report has been added to Research and Markets' offering.

Seminar materials from Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA (News - Alert), USP and ICH)

Analytical methods and procedures should be validated to ensure reliability, consistency and accuracy of analytical data. Compendial methods should be verified to demostrate the suitability of laboratories to successfully run the method and when methods are transferred between laboratories successful transfer should be demonstrated through testing. In case a laboratory wants to use an alternative method instead of a compendial method, equivalency of the alternative method to the compendial method should be demonstrated.

Method validation recently got highest attention from regulatory agencies and industry task forces. For example, FDA and EMA released guidelines on method validation and transfer, and USP has proposed new approaches chapters for integrated validation, verification and transfer of analytical procedures, for equivalency testing and for statistical evaluation.

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