GMP Monitoring and Continuous Process Verification: Stage 3 of the FDA Process Validation Guidance

  • Richard K. Burdick
  • David J. LeBlond
  • Lori B. Pfahler
  • Jorge Quiroz
  • Leslie Sidor
  • Kimberly Vukovinsky
  • Lanju Zhang
Part of the Statistics for Biology and Health book series (SBH)


The FDA Process Validation Guidance (2011) advocates Continued process verification Procedure validation a life cycle approach to product manufacturing which ensures the process can reliably and consistently produce quality product that meets the therapy’s desired efficacy and safety profile. This life cycle approach emphasizes collection and evaluation of appropriate data as evidence to demonstrate that the process is in a controlled state to deliver quality product. It has three stages: Process design, process qualification, and continued process verification (CPV). In CPV stage, data are continuously collected and evaluated to verify the process remains in the desired controlled state. This chapter discusses the key components of CPV and statistical tools that are useful for this purpose.


Acceptance quality level (AQL) Acceptance sampling Annual product review Continued process verification Corrective and preventative action (CAPA) Critical material attribute (CMaA) Critical method attribute (CMeA), Critical process parameter (CPP) Critical quality attribute (CQA) Lot tolerance percent defective (LTPD) Operating characteristic (OC) curve Out of specification (OOS) Process capability Statistical control charts 


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Copyright information

© Springer International Publishing AG 2017

Authors and Affiliations

  • Richard K. Burdick
    • 1
  • David J. LeBlond
    • 2
  • Lori B. Pfahler
    • 3
  • Jorge Quiroz
    • 4
  • Leslie Sidor
    • 5
  • Kimberly Vukovinsky
    • 6
  • Lanju Zhang
    • 7
  1. 1.Elion LabsLouisvilleUSA
  2. 2.CMC StatisticsWadsworthUSA
  3. 3.Merck & Co., Inc.TelfordUSA
  4. 4.Merck & Co., Inc.KenilworthUSA
  5. 5.BiogenCambridgeUSA
  6. 6.PfizerOld SaybrookUSA
  7. 7.Nonclinical Statistics, Abbvie Inc.North ChicagoUSA

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