PDA Technical Report No. 60 (TR 60) Process Validation: A Lifecycle Approach (single user digital version)
- Published
- Feb 2013
- ISBN
- 9780939459513
- Pages
- 102
- PDA Item Number
- 43502
Premium Members: to claim your annual free technical document download, email membership@pda.org and indicate the document you wish to claim.
- Format
- PDF Single user
- Member Price
- $180.00
- Nonmember Price
- $325.00
- Government Price
- $180.00
Please sign in or become a member to purchase items from the PDA bookstore.
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 info@pda.org.
Click here to order paper ship version (Item no. 01060).
Table of Contents
Table of Contents:
Click here to download >>> Detailed Table of Contents- Introduction
- Glossary of Terms
- Building and Capturing Process Knowledge (Stage 1 — Process Design)
- Process Qualification (Stage 2)
- Continued Process Verification (Stage 3)
- Process Validation Enabling Systems and Technology
- Examples
- Appendices
- References