InterviewSolution
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What Are The Benefits Of Method Validation? |
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Answer» Method validation assures the scientific veracity of analytical results and is a key component of total quality management. PROPER validation of a method provides documented evidence of method performance and prescribes on-going measures to ENSURE quality monitoring for the life of the method. Well-documented validation facilitates internal QC/QA review and expedites client, sponsor, and regulatory audits by providing clear links between a validated method and the systems, facilities, and procedures upon which the method is founded. Regulatory bodies governing the approval of drugs for human use require validated METHODS for routine testing for that end. Laboratories that make method validation a part of standard operating procedures PROVIDE themselves a clear means of successful continued support of drug development and production activities. Method validation assures the scientific veracity of analytical results and is a key component of total quality management. Proper validation of a method provides documented evidence of method performance and prescribes on-going measures to ensure quality monitoring for the life of the method. Well-documented validation facilitates internal QC/QA review and expedites client, sponsor, and regulatory audits by providing clear links between a validated method and the systems, facilities, and procedures upon which the method is founded. Regulatory bodies governing the approval of drugs for human use require validated methods for routine testing for that end. Laboratories that make method validation a part of standard operating procedures provide themselves a clear means of successful continued support of drug development and production activities. |
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