PDA TR 60

Technical Report No. 60 (TR 60) Process Validation: A Lifecycle Approach

Parenteral Drug Association , 02/01/2013

Publisher: PDA

File Format: PDF

$162.00$325.00


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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