A Guide to Good Validation Practices (Second Edition)

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A Guide to Good Validation Practices (Second Edition)

Product Type: Market Report
Published Date: December 2004
Published By: Drug & Market Development
Page Count: 133
Order Code: R294-0124
Print Copy $395
The regulatory authorities, when examining the submissions from drug manufacturers for permission to proceed to clinical trial (e.g. USA IND), or to market the product (NDA), are placing increasing emphasis on adequate validation documentation. This documentation must demonstrate that all critical activities that may affect the safety, purity or efficacy of the product are properly defined, controlled and reproducible in performance. Validation requirements may be applied to the manufacturing facility, its critical services and systems, the manufacturing processes, and all analytical test methods used to demonstrate the conformation of the product with its pre-set specifications.