USP <1220> and ICH Q14/Q2(R2) using Empower / Part I - Development

The USP general chapter <1220> "Analytical Procedure Life Cycle" became official in May 2022. The adoption of this guideline makes your lab ready for the adoption of the ICH Q14 “Analytical Procedure Development” and Q2(R2) “Analytical Validation”, expected later in 2023.

These quality guidelines are relevant for both analytical development and QC testing at pharma companies. Empower and Waters solutions support all 3 steps of the guideline, namely:

• Development

• Validation

• On-going Verification

In Part I we will describe how Empower supports Step 1 – Development through the integration with selected QbD software that enables the required DoE approach.

Presnter: Andrea Gheduzzi (Principal Pharma Development Specialist)