Stability Studies

The purpose of a stability trial is to demonstrate how environmental factors affect products. For example, temperature, humidity and light, can all impact the quality of a finished product. Stability trials provide pivotal evidence on the stability of an active in a product. Trials also aid the assignment of a product’s shelf life and storage restrictions.

Annual Stability Studies

Annual studies monitor how your product behaves over time. It is often used to collate data to support shelf life and storage assignments. Manufacturing and packaging should represent all future product batches. This is so the stability trials can be as accurate as possible to reflect the nature of the product.

Changing the Manufacturing Process

It is a regulatory requirement for all licensed products and medical devices to be tested. Any changes to the manufacturing formula or manufacturing process needs to covered by a stability trial. This is to monitor how the changes impact a products quality over time and under environmental factors.

BCM Stability Trial Services

Our services include full pivotal and in-use testing for a variety of dosage forms for new license applications. These trials abide to the ICH guidelines.

ICH Storage Requirements

Our range of stability cabinets stand in accordance with the ICH storage requirements for all your product and market needs. They are continually monitored to ensure stability trials fulfil all GMP requirements. Stability cabinet conditions will be dependent upon a products storage requirement at any given time. Below lists all availabilities, including a variety of other temperatures, with or without humidity:

BCM Analytical services have a dedicated Sample Management Team to create stability trials to meet your specific requirements including full analytical testing or storage only trial.

• 5°C
• 25°C/60% RH
• 30°C/65% RH
• 30°C/75% RH
• 40°C/75% RH
• Light Cabinet (Photostability testing)

ALSO SEE:  STORAGE   ANNUAL STABILITY   SPECIALIST STUDIES