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

Feb 2013
PDA Item Number

Premium Members: to claim your annual free technical document download, email [email protected] and indicate the document you wish to claim.

PDF Single user
Member Price
Nonmember Price
Government Price

PDA's 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.

Available to download
Format: PDF (1 file 1.24 MB)

Click here to view the digital downloading instruction and Terms of Usage

*To purchase licensing, please contact PDA at [email protected].

Click here to order paper ship version (Item no. 01060).

Table of Contents

Table of Contents:

Click here to download >>> Detailed Table of Contents
  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