Introduction

The process validation protocol is relatively easy to prepare IF all of the characterizations and work up of the process has been completed in Stage I. By the time the process performance protocol (PPQ) is to be written the following items should have been prepared and completed (approved and signed as necessary):

• The Validation Master Plan

• All Process Equipment to be used in the process has been qualified

• All Process utilities to be used have been at least commissioned and/or qualified

• Computer systems and Automation controls are qualified/validated

• The process has been fully worked out and the sources of variation have been identified

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