Incorporating Water Activity Testing in New Pharma Initiatives

Presented by

Brady Carter, Research Scientist – Decagon Devices Inc.

About this talk

Incorporating Water Activity Testing in New Pharmaceutical Initiatives This seminar will provide an overview of effective utilization of water activity as part of new pharmaceutical initiatives such as ICH and QBD. USP 1112 outlines strategies based on water activity that can reduce the amount of microbial limit testing needed for products with lower water activities. These strategies can be applied to drug release quality programs that are developed using ICH or QBD guidelines. The primary goal of these initiatives is to create risk-based, science backed quality programs. In terms of microbial safety of drug products, the new quality initiatives indicate that products that are “dry” are candidates for reduced microbial limits testing. Water activity is the only effective screen for “dry” conditions that prevent microbial spoilage as evidenced in scientific literature while moisture content is not. Water activity is also related to other critical quality attributes such as dissolution, excipient performance, and degradation of API. Utilization of water activity testing requires an understanding of water activity and this seminar will define water activity and describe methods for accurately measuring it. The seminar also will discuss the relationship between water activity and critical quality attributes and discuss strategies for implementing water activity testing in drug quality programs. 5 Major Learning Objectives: 1) What is water activity? 2)How are water activity and moisture content different? 3)How is water activity measured? 4)What critical quality attributes is water activity related to? 5)How can water activity be used with ICH? 6)How can water activity be used with QBD?

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