Strategies for Raw Material Variability
Very little information is currently available describing systematic approaches that could be applied in the development stage to characterize raw material variability. Such knowledge is needed to develop an appropriate process to manage this variability.
ICH Q8 outlines the expectations for a comprehensive pharmaceutical development strategy. One of the goals is to generate product and process understanding to a level where it supports process control to compensate for raw material variability in an adaptable way and assure constant quality drug product. In open literature a number of examples is available discussing the detrimental impact raw material variability might have. Unfortunately these cause and effect relationships are quite often only established after the effects manifested themselves in regular production lots. During this session, the PPD CoP will share examples of industry strategies for dealing with such raw material variability.
At the conclusion of this session, participants will:
- Understand the complexity of raw material variability and its impact on process performance
- Identify several strategies for understanding, managing, and mitigating raw material variability
- Jeff Campie, USA
- Richard Forsyth, Senior Consultant, Hyde Engineering + Consulting, USA
- Nigel Hamilton, Global Quality, Strategy and Process Excellence, Sanofi Aventis, United Kingdom
- Aisling Horan, Validation Scientist, Alkermes Plc, Ireland
- Edwin Melendez, Principle Consultant, Parexel, USA
- Mark O'Reilly, Director Engineering, Alkermes Pharma Ireland Ltd, Ireland
- Kimberly Ray, A. Director Project Mgmt, Oso Biopharmaceuticals Mfg LLC, USA
- Julian Wilkins, Vice President, PharmaConsult US Inc, USA
- Paul Wreglesworth, Independent Consultant, United Kingdom