Process Qualification: Stage 2 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)


In Chap. 3, the first stage of the FDA’s 2011 process validation guidance was described demonstrating various options to drive process understanding using experimental design . The resulting process design experiments yield information that can be used to define future operating ranges for the new process. The second stage of process validation is process qualification.


Data analysis Effects of scale Equivalence testing Inter-batch variation Intra-batch variation Lot homogeneity Lot-to-lot variation Process characterization Process performance qualification (PPQ) Profiler PPQ batch size Risk management solution 


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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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