Strategies for Raw Material Variability

Session 306
Technology Track

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.

Session Description

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

Leaders

Speakers