Delve into the ICH Harmonized Tripartite Guideline and shed light on the crucial considerations and procedures for effective photostability testing.
Understanding the ICH Guidelines
The ICH Harmonized Tripartite Guideline emphasizes the need for evaluating the intrinsic photostability characteristics of new drug substances and products. The document outlines a systematic approach to photostability testing, covering tests on the drug substance and various stages of the drug product packaging. BioBoston Consulting recognizes the importance of adhering to these guidelines for successful registration applications, ensuring the submission of robust photostability information.
Choosing the Right Light Sources
One of the key aspects of photostability testing is the selection of appropriate light sources. Whether opting for artificial daylight fluorescent lamps or a combination of cool white fluorescent and near ultraviolet lamps, understanding the spectral distribution specifications is crucial. Our experts guide clients on maintaining temperature control and the inclusion of dark controls for reliable testing outcomes.
Confirmatory studies, exposed to specific illumination and ultraviolet energy, play a pivotal role in determining the effects of light exposure. Our consultants provide valuable insights into using validated chemical actinometric systems and calibrated radiometers/lux meters for accurate monitoring.
Drug Substance Testing
For drug substances, we recommends a dual-phase testing approach—forced degradation testing and confirmatory testing. Understanding the intricacies of forced degradation testing aids in method development and degradation pathway elucidation. With a focus on presentation and analysis of samples, our firm guides clients in minimizing interference and selecting appropriate containers for various drug substance states.
Drug Product Testing
Navigating drug product testing involves a sequential approach, progressing from fully exposed products to those in immediate and marketing packs. BioBoston Consulting stresses the importance of confirming photostability characteristics on selected batches and provides guidance on when additional testing may be necessary.
By aligning with ICH guidelines and employing a systematic approach, our firm ensures that clients navigate the complexities of regulatory requirements with confidence.