Title: Lifecycle-Based Process Validation Emphasizes the Need for Continued Process Verification, 4p.

A year’s worth of FDA warning letters suggest that API and finished drug manufacturers should strengthen their approach to continued process verification. In 2011, when FDA revised its process validation guidance (1), it introduced the idea that validation must continue throughout the lifetime of a pharmaceutical product. FDA advocated three stages: Process design, using the principles of pharmaceutical quality by design (QbD) Process performance qualification (PPQ) Continued process verification (CPV).

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   Person Information
   Application Sequencing
 325412 - Pharmaceutical Preparation Manufacturing                
Company  Product  Process  Other  Subjects  Event  Event  Date  Location  Publication  Publication  Date Text  Descriptor
  • Food & Drug Adminstration

  • Contamination Control

  • Validating





  • Pharmaceutical Technology


  • 8/1/2018


  • Abstract