Conditions for walk-in and reach-in chambers
ICH Compliant 24/7 Temperature and Humidity Controlled and monitored.
Your stability studies are safe and secure with our alarm notification system. In the event of a set point failure all appropriate supervisory personnel are notified by phone and alarm monitoring services.
All maintenance and service is provided by qualified engineering support. Maintenance records and monitoring data can be viewed during an audit. To reduce down time from potential chamber failures all parts are inventoried on site.
Storage-only services are available. Quotes are based on individual client specifications.
Compliant and on Time Stability Solutions to Meet Your Program’s Needs
Stability studies, stress tests and forced degradation tests are a critical component of drug development for the assessment of drug storage or shipment conditions, expiration date, and packaging. They provide a thorough understanding of the chemical behavior, degradation pathways and the intrinsic stability of a new molecule. Therefore, to accelerate the registration process of a new drug product or substance, stability and forced degradation studies should be performed as early as possible in the drug development process.
QCL - Quality Compliance Laboratories Inc. has long supported the stability needs of its customers, through highly capable study design, stability storage and analytical services. As a facility with an industry leading track record in late phase and commercial experience, we understand the vital role stability testing plays in the drug development process.
Our extensive and comprehensive programs include fully validated and continuously monitored storage environments for ICH and WHO test conditions. In addition, we provide analytical capabilities to evaluate the physical, chemical, and microbiological properties of solids, liquids, semisolids, and parenteral formulations.
Furthermore, we can support study design and management of forced degradation studies to assess the “stability-indicating” power of the analytical methods under development for stability testing, statistical support for stability testing which includes support in both sample management (i.e. statistical randomization sampling plans) and statistical evaluation of both long-term and accelerated stability data in line with ICH guidelines.
We offer the following integrated services in the stability field:
Our forced degradation studies and stress thermal tests encompass stress testing under acid or alkaline conditions, oxidative stress testing, and photostability studies. Based on the client’s specific needs, we can develop and tailor stability studies as well as forced degradation tests at any stage of the drug development.