Stability Testing (Drug Products)

05 Dec - 06 Dec 2022

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Workshop Overview

Stability testing of pharmaceutical products is an essential element of many product development programs, but organizations struggle to identify what testing is needed and when it should be performed. A critical review of most stability programs shows that in many cases more work than is planned than is actually needed. Sadly in other programs, key elements of what is needed has not been planned. Simply following the ICH guidelines does not necessarily give the optimum shelf life for the product. This course will help attendees to identify what testing is needed, and how to safeguard the quality of stability testing program by taking simple steps to ensure data integrity.

Program Focus

The objectives of the course are to give the delegates a comprehensive understanding of the principles and process of pharmaceutical product stability testing, when it is required, and what should be done to ensure that a stability testing program generates reliable data suitable for supporting a product registration package including correct interpretation of the data.

Benefits of Attending

Able to identify the requirements for a valid stability program which will meet the ICH requirements
Analyse stability data and derive product shelf life in accordance with ICH guidelines and statistical priinciples
Understand the risks and benefits of matrixing and bracketing
Comply with current GMP requirements to avoid inspection failure
Interpret ICH guidelines Q1A, Q1B and Q1E