Based on international guidelines (ICH, FDA and WHO) stability studies have to be performed on drug substances (DS) and drug products (DP) in order to guarantee quality and efficacy during whole life cycle. Stability testing encompasses all phases of the drug development process, but is also required for the registration phase and beyond to show consistent quality. Our stability studies for pharmaceuticals help you to measure and document time relevant changes to the quality, safety and efficacy of drug products and drug substances.
Why choose stability studies for pharmaceuticals from SGS?
We can help you:
- Simulate conditions under which a drug substance or drug product is subjected – from manufacturing to final application
- Determine how the quality of a drug substance or drug product varies under influence of temperature, humidity and light
- Define the appropriate conditions and timeframe, accounting for the fact that most chemical reactions follow logarithmic and not linear functions
- Define retest periods of drug substances or the shelf-life of drug products and recommended storage conditions
- Demonstrate that the drug product is in compliance with the acceptance criteria throughout its lifecycle
World-leading Stability Studies From a Trusted Provider of Testing to the Pharmaceutical Industry
As a world-leading provider of testing, certification, verification and inspection services, we offer you unrivaled expertise in providing stability studies for the pharmaceutical industry. We provide the flexibility to accommodate your specific protocols, supporting bracketing and matrixing, specified time-points, sample configurations and sample amounts as well as other international requirements. We can also set up specific storage conditions and site conditions as described in guidelines.
Our state-of-the-art procedures are established worldwide, following GMP requirements. Storage conditions, such as temperatures (and humidity when controlled) are continuously monitored by our facilities monitoring system. All chamber thermistors, thermocouples, humidity sensors, and radiometers/lux meters are calibrated and traceable to international standards.
We offer tailored solutions for your needs with high-flexibility and adherence to stability testing guidelines within a wide variety of projects and circumstances.
To discuss your stability study requirements, contact us today.