Outsourcing ICH Stability Storage
Outsourcing GMP stability storage for pharmaceutical or healthcare products where large capacity storage and ICH or bespoke conditions are required including contracts to cover storage only, ICH stability testing services, disaster recovery or contingency storage strategies
Outsourcing drug stability storage management can significantly reduce costs and de-risk your pharmaceutical development program. Choosing to outsource should stem from strategic planning for your long-term stability needs and selecting the right vendor with GMP compliant facilities and highly trained staff experienced in managing complex stability studies is a key consideration. Outsourcing of stability storage allows you to focus on your core competencies whilst enabling a reduction in costs, demand for in house technology and staff resources and also free up precious real estate.
Sourcing suitable storage capacity can also be an issue for many pharmaceutical companies. Practical issues such as the necessary footprint required to place new walk-in chambers, the cost of commissioning an in-house facility and the costs and resource demands related to validation and a continuous monitoring system to ensure they are 21 CFR part 11 compliant. It is also entirely likely that in the future you may require an expanded volume of storage making your current in house capacity no longer suitable. To overcome these challenges, partner with Intertek, a leading provider of outsourced stability storage.
Outsourcing Storage Capacity
Our UK storage facility, located near Cambridge, is GMP compliant and is one of the largest storage facilities in Europe with 375,000L capacity. All climatic walk-in chambers, cabinets and refrigerated as well as freezer storage, are fully controlled and monitored with backup chambers. All sites have 24-hour alarm systems with dedicated on call teams to react to the excursions from storage conditions. We can provide ICH conditions or bespoke conditions storage supported by an experienced team who ensure that all 21 CFR part 11 monitored equipment is suitability qualified and validated.
We consistently demonstrate excellence in project management and quality with a focus on knowledge of relevant ICH guidelines, clear understanding of our clients’ stability protocols or each stability disaster recovery client notification plan, excellent record of operation, maintenance and calibrations of stability chambers, freezers, and refrigerators alongside clear qualification documentation (IQ/OQ/PQ).
With over 20 years of experience, we have a proven track record in managing stability testing studies and providing Total Quality Assurance for controlled temperature and humidity storage stability storage for a wide range of global clients. We typically have over 300 studies in process at any time and our facilities have potential expansion capacity for an additional 300,000L if required.
Pharmaceutical stability studies are complex. They demand considerable financial investment, time and scientific expertise and disruption could impact the product’s market launch. To reduce risks associated with stability storage, partnership with a specialist outsourcing provider, such as Intertek can de-risk the process. Our stability team offer responsive and bespoke relief storage to help you meet the challenges of disasters such as extreme weather, flooding, fire, electrical failures, power outages, software failure or even human error – all of which can lead to months or years of lost time with significant financial impact.
Our disaster recovery solutions are managed by competent experts and our responsive disaster recovery procedure covers any emergency transfer of samples from your site from individual batches to entire chambers of samples should your own stability chambers go down. We provide suitable capacity/conditions, even with bespoke conditions, in a facility that is monitored, fully validated and alarmed.