Providing evidence on the quality of your product.

The ICH Q1A guideline defines the stability data required for a new drug substance or drug product that is sufficient for a registration application within the EC, Japan, and the United States.

With over 40 cubic meters of stability storage capacity, in which all conditions are mapped, qualified and validated to ensure traceability to national standards, our stability testing services include:

• Temperature and humidity ranging from 40°C/75%RH to - 20°C
• R&D stability testing
• In-use studies
• Photo stability
• ICH stability testing for:
  • Investigational Medicinal Products
  • Market Approved Products
• Non-ICH conditions supported

With on-site analytical chemistry and microbiological support as well as 24hr monitoring of all cabinets and chambers, we manage your stability testing projects effectively and efficiently.

For further information on our Global service offering please email pharmaservices@gen-probe.com