ICH STABILITY GUIDELINES AND STORAGE CONDITIONS
We offer storage solutions that satisfy the ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) storage condition guidelines.
What are ICH Stability Guidelines?
ICH stability guidelines are policies that help determine and maintain the efficacy of drugs and pharmaceuticals. Established by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), these guidelines ensure that the quality of a drug product keeps throughout its shelf life.
The ICH stability guidelines fall into different climatic zones to provide a comprehensive set of requirements for stability testing under various environmental conditions. Additionally, these guidelines cover areas such as the design of stability studies, storage conditions, testing frequency, and data analysis and help regulatory bodies and manufacturers align on scientific methodologies.
Pharmaceutical companies that adhere to the ICH stability guidelines can demonstrate that their products meet the necessary quality, efficacy, and safety criteria to keep patients safe.
ICH Storage and Stability Conditions for Testing
The ICH guidelines specify the ideal conditions for conducting stability testing according to different climatic zones to reflect the global nature of the pharmaceutical industry. Below are the storage and stability conditions defined by ICH:
- Long-term Testing Conditions: Long-term testing demonstrates the stability of a product during its proposed shelf life in the intended market. For Zone I (temperate) and Zone II (subtropical and with possible high humidity), this includes 25°C ± 2°C/60% RH ± 5% RH for 12 months or more and 30°C ± 2°C/65% RH ± 5% RH for 12 months or more, respectively.
- Intermediate Testing Conditions: Intermediate testing conditions are necessary when a significant change occurs at long-term conditions. In such cases, testing at an intermediate condition, such as 30°C ± 2°C/65% RH ± 5% RH for Zone I and Zone II, might be carried out for six months or longer.
- Accelerated Testing Conditions: Accelerated testing conditions can help predict the product’s stability profile in a shorter time frame. Typical conditions for this testing are 40°C ± 2°C/75% RH ± 5% RH or 40°C ± 2°C/not more than 25% RH over six months.
- Special Testing Conditions: Special testing conditions are for products that require specific requirements, such as refrigeration or freezing. For example, manufacturers might test products that require refrigeration at 5°C ± 3°C to determine their efficacy.
WE STORE SAMPLES IN OUR PHARMACEUTICAL STABILITY STORAGE CHAMBERS
Precision Stability and storage recognizes the importance of reference samples.
Reference samples – starting material samples kept safe for testing and analysis
We provide space specifically validated to accept retains for products requiring storage between 15° and 30° and that follows FDA guidelines regarding the storage of reference standards.
NUTRACEUTICALS, BIO-SCIENCES, GENETICS, COSMETICS, & TOBACCO
Precision can work with your Quality Assurance group to establish a proper storage protocol for your stability studies or follow your existing protocol. We maintain over 10 of the commonly recommended ICH stability storage conditions to provide the proper climatic zone for your study. Whether it be trial batches of a new product, API, or medical devices, we can accommodate your needs.
Precision upholds the highest sample management standards as we receive and inventory your pharmaceutical products. We’ll store your product in the pre-specified chamber at your desired product orientation, follow your protocol per pull dates, and confirm that the proper amount of samples are pulled per your selected dates and reserves.
Precision can ship your samples back to your facility or to a specified group for testing. Our stability storage facilities are equipped to provide shipping at specific temperatures from -20 to ambient temperatures and to log data during the shipment. If you are located near the storage facility, we can make pick-ups and deliveries. We also have many customers that use express shipping to destinations across the country.
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