Electronic PDA Technical Reports

PDA Technical Report No. 60 (TR 60) Process Validation: A Lifecycle Approach (single user digital version)

PDA's newest technical report Process Validation: A Lifecycle Approach presents timely and real world guidance for the application of a lifecycle approach to process validation. The lifecycle approach has been the focus of recent process validation guidance from major regulatory agencies and represents a significant change in expectations in this area. This technical report, part of the PCMOsm initiative, will review requirements for process validation studies across the three-stage approach defined by FDA and also discuss best practices for integration with supporting Quality Systems.

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Format: PDF (1 file 1.24 MB)

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Table of Contents:

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  1. Introduction
  2. Glossary of Terms
  3. Building and Capturing Process Knowledge (Stage 1 — Process Design)
  4. Process Qualification (Stage 2)
  5. Continued Process Verification (Stage 3)
  6. Process Validation Enabling Systems and Technology
  7. Examples
  8. Appendices
  9. References
  • Figures and Tables Index

  • Date of Publication: February 2013
    ISBN Number: 9780939459513
    Format: PDF
    Number of Pages: 102
    Binding: