PDA TR 60
- Technical Report No. 60 (TR 60) Process Validation: A Lifecycle Approach
- Report / Survey by Parenteral Drug Association, 02/01/2013
- Category: PDA
$325.00
$163.00
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 PCMO(sm) 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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