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Articles by David A. Porter

David A. Porter


David A. Porter is a pharmaceutical consultant with Vectech Pharmaceutical Consultants, Inc.

Qualification, Validation, and Verification
April 2, 2007

This article considers the distinction among the terms qualification, validation, and verification in the context of pharmacopeial usage.A recommendation for a standardized usage of the terms validation and verification is provided,and general requirements for validation and verification activities are given.The article also emphasizes the importance of knowing when validation or verification is necessary relative to the use of a method to satisfy pharmacopeial article requirements (for which a monograph exists in the pharmacopeia) or for nonpharmacopeial use.

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