Optimising Sample Preparation

Key learnings

• Frequent challenges with interpretation of sample preparation procedures
• Sample preparation risk assessment using fishbone diagrams and heat map tables
• Design of Experiment (DoE) approach for sample preparation optimisation
• Final method conditions with robustness simulator and MODR
• Writing a Standard Operating Procedure (SOP) with an Analytical Target Profile (ATP) for compendial and validated methods

Overview

Out-of-Specification (OOS) results in the regulated QC laboratory represent a major source of wasted resources in terms of investigation time, costs, and increased time to market.

The occurrence of OOS results originating in the lab can be significantly reduced by focusing on commonly neglected areas:

• Is the instrumentation being used fit for its intended purpose?
• Is the analytical procedure well understood?
• Are the users appropriately trained?

Presenter: Dr Stephanie Harden (Market Development Manager, Pharmaceutical Development & Manufacturing, Waters Corporation)

Stephanie isresponsible for the development of Waters’ small molecule pharmaceutical business, the largest revenue-generating market segment within Waters' European operations. Stephanie has many years experience developing and coordinating business growth strategies and works closely with her internal and external customers, building partnerships, ensuring mutual benefit and contributing to Waters' continued success.