Have you ever wondered how pharmaceutical companies ensure that the medications you rely on remain safe and effective throughout their shelf life? How can you be sure that the vitamin, antibiotic, or vaccine you’re taking is still effective, safe, and stable? This is the goal of ICH Stability Storage.
ICH stability is a crucial aspect of pharmaceutical development and quality assurance. By simulating real-world storage scenarios, ICH stability testing helps ensure that pharmaceuticals maintain their safety, efficacy, and quality throughout their intended shelf life.
What is ICH Stability Testing?
ICH Stability Storage refers to the storage conditions and testing protocols recommended by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) for assessing the stability of pharmaceutical products.
The ICH guidelines provide standardized methods for conducting stability studies to evaluate the effects of environmental factors such as temperature, humidity, and light on the quality and shelf life of drug products. These studies are an essential part of the drug development process to ensure that the product remains safe and effective. The results also help establish optimal storage conditions for pharma products and ensure patient safety.
The ICH Process
ICH Stability Storage typically involves storing samples of the drug product at various prescribed temperature and humidity conditions for a specified period of time. The samples are then tested at regular intervals to assess their physical, chemical, and microbiological stability. The results of these studies are used to establish the product’s expiration date and storage recommendations.
Stability storage conditions are typically categorized as long-term (25°C/60%RH), intermediate (30°C/65%RH), and accelerated (40°C/75%RH) to simulate different storage conditions that the product may be exposed to during its life cycle. These conditions are based on real-world storage conditions and are intended to provide a comprehensive assessment of the product’s stability.
Take the Next Step with Purple Diamond
As the pharmaceutical landscape continues to evolve, partnering with experts in ICH Stability Storage becomes increasingly crucial. Purple Diamond offers state-of-the-art facilities and extensive experience in conducting stability studies that adhere to ICH guidelines. Whether you’re developing a new drug or seeking to optimize your existing stability testing protocols, Purple Diamond’s team of specialists can provide tailored solutions to meet your specific needs. Contact us today to get started and take the next step in your go-to-market strategy.
