Strengths and Challenges in Analytical Development in Pharmaceutical Industry

Analytical method development, validation and transfer are key elements of any pharmaceutical development program. This technical brief will focus on development and validation activities applicable to drug substances. Even though considered routine, insufficient attention is paid to these activities and their potential to contribute to overall developmental time and cost efficiency. Effective method development ensures that laboratory resources are optimized and the method adopted meets the desired objectives at each stage of drug development. Method validation is defined as the “process of demonstrating that analytical procedures are suitable for their intended use”. It is required by regulatory agencies at certain stages of the drug approval process. Method transfer is the formal process of assessing the reproducibility of methods in another laboratory. Each of these processes contribute to continual improvement of the methods used and improve the efficiency of drug development.

With stringent limits being set for impurities; identification and reliable quantitation become essential. Several organizations are reaping substantial business benefits by implementing a systematic approach to method development. Robust analytical method significantly reduces or eliminates the Cost of Poor Quality (COPQ) during the manufacture of drug substances. This webinar will highlight the principles of method development, validation ICH Q2 (R1) and Method transfer and their effectiveness to bring proper controls and deliver right quality materials the first time. These concepts will be illustrated using case studies.

The webinar will focus on the significance and challenges involved in analytical method development, validation and transfer. The audience will also learn about the systematic adoption of these principles, while understanding the analytical process scientifically with a risk based approach.

Key takeaways from the webinar:

Analytical method development – How to develop a scientifically sound analytical method

Analytical method validation - Purpose of method validation for a scientifically sound analytical method

Analytical method transfer - Challenges and solutions for analytical method transfers

Genotoxic impurities - Quantification techniques to determine PGI.