In this article, we will look at ICH stability testing and ICH stability storage guidelines to determine what they mean for your company.
Article Contents
What Is ICH Stability Testing?
ICH stability testing guidelines, which are used by both the Food and Drug Administration (FDA) and the European Medicines Agency (EMA), help ensure the accuracy of pharmaceutical testing results. ICH guidelines state that stability testing is intended to show how a pharmaceutical product's quality will change over time under a variety of environmental conditions, including heat, humidity and light. It's an essential part of drug formulation and development.
Pharmaceutical stability testing results are used by the FDA, EMA and other similar governmental regulatory agencies to determine approval for new products. These results also determine the optimum storage conditions and expiration dates for new pharmaceutical products.
ICH stability testing is usually conducted during the clinical trials for a new drug, but often is continued throughout the testing and study process.
All drug substances, drug products, combination devices and raw materials need to be assessed for stability.
ICH Stability Storage Guidelines
ICH stability storage guidelines provide the ideal storage conditions and times for long-term, intermediate and accelerated stability studies.
The ICH has established five different climatic zones for stability studies. Since ICH stability testing is designed to determine how a drug reacts under different environmental conditions, the climatic zones have been created to allow storage under conditions that simulate the climatic conditions of the country in which the new product will be sold.
Below are the general guidelines for ICH stability storage conditions in each climatic zone.
| ·Zone I | Temperate | 21°C/45% Relative Humidity |
| ·Zone II | Mediterranean/Subtropical | 25°C/60% RH |
| ·Zone III | Hot, Dry | 30°C/35% RH |
| ·Zone IVa | Hot Humid/Tropical | 30°C/65% RH |
| ·Zone IVb | Hot/Higher Humidity | 30°C/75% RH |
Precision stability storage is required to ensure long-term safety and efficacy of new pharmaceutical products.
Who Should Conduct ICH Stability Testing and Storage?
While you can conduct your own ICH stability testing and storage, there are some benefits to outsourcing these services to a company that specializes in pharmaceutical formulation and development.
Some of these benefits of stability storage and testing being outsourced include:
- Letting the experts do the work. Outsourcing your ICH stability testing to an experienced company that specializes in drug manufacturing will give you peace of mind. With 24/7 monitoring of your product and round-the-clock security, you can trust the results you receive.
- Freeing up valuable storage space. Space can be at a premium for any company. Use the space you have available in your facility for other purposes and use a third-party facility for storage.
- Customizing storage solutions. Providing the optimal conditions to meet ICH storage guidelines can be a difficult, expensive proposition if you do not already have the proper storage conditions in place. Outsourcing allows you to tap into custom stability conditions already in place at another facility.
CONTACT US
Choose UPM Pharmaceuticals for Your ICH Stability Storage and Testing Needs
If you're looking for an experienced ICH stability storage and testing partner, count on UPM Pharmaceuticals. Stability testing can present unique challenges, and specialized knowledge is required to develop methods and analyze results. Our ICH stability storage services and testing capabilities will meet any regulatory requirements for your new product.
When you're looking for the full range of commercial manufacturing services for pharmaceuticals, UPM is your best choice. Contact us today and find out how we can help your company.
Reach Out Today
