Parenteral products, which include sterile drugs, solutions, emulsions, and suspensions, are distinct from other pharmaceutical dosage forms due to their stringent requirements. All parenteral products must be sterile and free from pyrogenic (endotoxin) contamination. These unique characteristics underscore the critical importance of rigorous testing protocols throughout the product lifecycle.
Release and Stability testing are vital components of new drug development, conducted continuously to ensure that the quality, safety, and effectiveness of drug products are maintained throughout their shelf life. These studies are essential requirements, confirming that the drug products remain within acceptable specifications over time.
This webinar provides a comprehensive overview of Parenteral Drug Products Release testing, highlighting the processes involved in ensuring that products meet the necessary sterility and safety standards before they reach the market. Attendees will gain insights into the methodologies used to test for sterility, endotoxin contamination, and other critical parameters.
Additionally, the webinar will cover the International Council for Harmonisation (ICH) guidelines for Stability testing. These guidelines outline the procedures for conducting stability studies to assess how the quality of a drug substance or drug product varies with time under the influence of various environmental factors such as temperature, humidity, and light. Understanding these guidelines is crucial for developing robust stability testing protocols that ensure the long-term efficacy and safety of parenteral products.
By the end of this presentation, participants will have a clear understanding of the importance of Release and Stability testing in the lifecycle of parenteral drug products. They will learn about the key tests and guidelines that ensure these products remain safe and effective throughout their shelf life, providing essential knowledge for professionals involved in the development, testing, and regulatory compliance of parenteral pharmaceuticals.