Module 3 Presentations

07/05/2024

Real Time Release – Ideal Case • Ideal case: eliminate the need for the majority of end product tests through a combination of  process understanding, models/algorithms  control of inputs  in-process tests to confirm and/or control the ‘trajectory’ of the manufacturing process

• End product will meet traditional specification if tested

• Aspects of traditional specification still required to monitor the stability of the product • Critical Stability Indicating Parameters

Developing Specifications for the Active Ingredient

The Organisation for Professionals in Regulatory Affairs

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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  ICH Q8 Pharmaceutical Development  ICH Q9 Quality Risk Management  ICH Q10 Pharmaceutical Quality Systems  ICH Q11 Development and Manufacture of Drug Substance

Developing Specifications for the Active Ingredient

The Organisation for Professionals in Regulatory Affairs

24