ICH Pharmaceutical StabilityTesting and Storage

Do you lack the space to house your own stability chambers or require additional storage capacity? Perhaps you need a special storage condition that your own facilities can’t accommodate? We are happy to assist with storage-only requests. Our laboratory experts can pull samples and ship on the same day, accommodate next-day delivery, and we also offer controlled shipping conditions.

Regulations require license holders to conduct stability studies to monitor product quality during routine manufacture.  We work closely with you to ensure annual stability studies are conducted in line with regulatory requirements and the necessary data is captured and reported to maintain product safety.

Accelerated stability studies are a key part of the development of a new consumer or pharmaceutical product’s stability profile and an efficient way to highlight and then troubleshoot problem areas early so you can avoid costly reformulations or redesigns.
 
We can conduct accelerated studies on your product to preview the potential degradation process in a shorter time frame to speed up the development cycle and help you get your product to market quicker. Early knowledge of stability behavior can save cost and time during pre-market regulatory projects.

Providing photostability data is a standard requirement for any new drug application. Whatever your photostability requirements, we have the expert analysis to support your project. 

At the end of each exposure period, we examine physical changes and report any assay and impurities changes that may arise from the photochemical degradation process.  From direct light exposure of the API to exposure of the final packaged product, our scientists can help assess the effect of light on the product and the product container closure system, help troubleshoot any issues, and recommend protective measures against photodegradation for better product safety.

Stability data is a key aspect of a regulatory submission, providing evidence of your product’s efficacy and safety over time. Our scientific and regulatory consultants are available to collaborate on new drug development projects from raw material selection and identifying suitable intermediates to testing finished products and packaging, including extractable and leachable studies.

When products are manufactured in a different country or shipped overseas, storage conditions in transit can reach outside stability tolerance and pose a risk to product safety, efficacy, and compliance requirements in the country of use.  
We can support this by conducting excursion studies and providing a full analysis of the quality profile of your product during exposure to the rise in temperature and humidity experienced during transportation.

Having a plan in place in the event of a disaster or crisis is an essential requirement for all companies and corporate entities.  We offer business continuity support, including detailed transfer protocols that can be executed within an agreed time frame should a disaster occur.  Speak to our laboratory Quality and Operations teams to learn how we can help you mitigate risk and ensure business continuity.