The VirtualPharm
The VirtualPharm Podcast is an audio series that covers topics related to compliance and regulatory affairs in the Lifesciences industry. Each episode, hosted by experts on the topic with decades of experience, offers listeners detailed insight into the changing regulatory environment. The podcast provides timely information about emerging regulations, legal updates, industry insights, and best practices for organizations. The episodes are informative and engaging, helping educate professionals on remaining compliant while staying agile in their industry.
The VirtualPharm
Mastering Stability Studies: The Blueprint for Drug Substance & Product Success
The podcast provides an overview of drug substance and product stability testing. They describe the importance of stability testing for ensuring product quality and safety. The texts highlight the complexity of FDA stability guidelines, which are intended to provide general principles for conducting stability testing. The sources then outline the specific guidelines for stability testing established by the International Conference on Harmonisation (ICH) and provide a step-by-step process for conducting stability testing. Finally, the texts emphasize the importance of following regulatory guidance and using validated methods to ensure the accuracy and reliability of stability testing data.