Module 3 2019

How does this affect the control strategy?

• Traditional Specification heavily reliant on end product testing (as described in ICH Q6A) • Real Time Release offers the opportunity to Eliminate, Move Up-Stream or Perform On-Line testing in lieu of end product specification testing • Extensive Process Understanding and appropriate

control needs to be demonstrated • Therefore infers a high level of control

Specification is one part of an overall control strategy

The Organisation for Professionals in Regulatory Affairs