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PDA Technical Report No. 60 Process Validation
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PDA/DHI Publications

PDA Technical Report No. 60 Process Validation
€ 265.00
net
€ 283.55
  7% VAT included
Print Version
US$
375.00
(TR 60)

Interpretation of the requirements of FDA and EMA on the life cycle approach.
Edition: 1st Edition 2013
102 Pages
ISBN: 978-0-939459-51-3
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 new 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.

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
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