Before new drug substances and drug products can be registered, companies must follow the guidelines and regulations developed by the International Council for Harmonisation of Technical Requirements for Human Use (ICH), World Health Organization (WHO), and the Food and Drug Administration (FDA) for stability storage and testing, where relevant. The following article primarily refers to ICH guidelines because while the WHO and the FDA have their own regulations, the WHO guidelines cross-refer those published by the ICH, and the FDA considers the ICH’s recommendations along with alternatives to accomplish the same goals and equivalent level of quality assurance.
Stability storage is used to determine how the quality and efficacy of pharmaceuticals or other regulated products are affected by environmental factors. Non-regulated products may also go through stability testing, though there are less strict guidelines. Stability testing ensures ingredients and products satisfy regulatory compliance and consumer safety requirements, as well as protect brand reputation.
Storage and Testing
Pharmaceutical stability storage is used in determining the shelf life and recommended storage conditions for drug products. Shelf life can be estimated by using the two different types of stability testing length: long-term and accelerated testing.
According to ICH guidelines, long-term testing should last for a minimum of 12 months and include at least three primary batches of the substance or product. Comparatively, accelerated testing involves three different time points for a minimum of 6 months, including the initial and final time points. For example, a 6-month accelerated testing study would likely have time points at the 0 months (initial), 3 months, and 6 months (final).
How to Test Stability
Other than length of time, stability testing includes different components based on various environmental factors, such as light and climate.
Photostability, which evaluates overall light sensitivity, involves forced degradation testing and confirmatory testing. Forced degradation is a process that involves testing drug products and substances under light exposure that is more severe than accelerated conditions. Confirmatory testing identifies if precautionary measures to light exposure are needed in manufacturing or in the formulation of the product or packaging.
ICH stability testing is divided into five different climate types based on temperatures and relative humidity (RH) around the globe. The temperatures for testing typically range between 20°C to 30°C with RH from 35% to 65%, depending on the climate zone type. Evaluating based on climate is essential because inappropriate levels of moisture and humidity may affect chemical reaction rates and could result in lower efficacy, lower quality, and shortened shelf-life.
In addition to photostability and temperature/humidity stability, stability testing can also include reference sample testing and Thermal Cycling. Reference sample testing (also called retain sample testing) serves as a record of the starting material or finished product batch to be assessed for compliance, reporting, or other reasons. Thermal Cycling is a freeze-thaw examination approach where substances or products are repeatedly cycled through different temperatures (extreme cold to extreme heat and humidity) to determine product resistance.
Finding a cGMP Stability Storage Partner
It is critical to maintain accurate temperature and humidity control to follow ICH and FDA regulations. Otherwise, the testing is faulty and requires repeating, which leads to lost time and additional costs.
With six global state-of-the-art facilities, SciSafe has over 7,000,000 cubic feet of storage and meets ICH, FDA, and WHO stability storage requirements. Our cGMP-compliant facilities have built-in humidity control and maintain a comprehensive range of temperature conditions, including:
- 25°C/60% RH for long-term stability testing
- 30°C/65% RH for intermediate stability storage
- 40°C/75% RH for accelerated stability studies
- Customized solutions
SciSafe is capable of customizing solutions to fit unique stability storage needs. When a pharmaceutical, biotechnology, and medical device company contacted us regarding stability at -90°C, we acquired a new ultra-low temperature freezer that maintains temperatures as low as -100°C for their testing needs. When the testing period has ended, our cold storage and precision logistics expert staff will handle and ship their invaluable, irreplaceable materials to ensure accurate results.
With 24/7/365 monitoring, backup systems, and the necessary temperature environments, we can securely store ICH Stability Testing, Vaccine Storage, Bulk API, Clinical Retains, and beyond. Contact SciSafe to discuss our range of stability storage and testing capabilities.