The purpose of the Auditing Handbook is to provide some specific information never before published on the subject of auditing
Institute of Validation Technologypurpose of the Auditing Handbook is to provide some specific information never before published on the subject of auditing. The introductory section provides a general overview of auditing and the author's personal experiences and observations regarding some aspects of auditing. The section that follows includes several hundred specific audit questions that represent atypical or more challenging cGMP compliance concerns. Finally, a very specific list of FDA inspection preparation recommendations is presented as "Preparing for an FDA Inspection is More than a Fresh Coat of Paint." This handbook was created to be an aid in improving the reader's operation.
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