Stability studies are an inherent part of the life cycle of a drug product as manufacturers will not get marketing authorisations without proving efficacy and viability.
Studies typically involve exposing products to a variety of parameters, including temperature, relative humidity, and light. Studies of this nature require specialised equipment and skilled personnel to execute the studies.
Stability studies are a long-term commitment, in some cases up to 5 years. In house stability testing is a cost-effective option when many studies are being run in parallel, however can you afford to divert your team away from their other projects? Outsourcing frees up core competencies, leaving the team available for other projects.
Environmental Chambers are often of a large footprint and take up valuable floor space that could otherwise be used for revenue generating production.
Outsourced stability storage providers work in a highly regulated environment and are frequently audited by customers and competent bodies; therefore, their processes are validated and the equipment will be qualified to exacting standards.
Transform CAPEX to OPEX
Instead of large Capital Expenditure Projects, manage your stability projects as part of an operational budget. Typically, a customer pays only for the space they use.
While Stability Studies are conducted in a highly regulated environment, they do not require a lot of manufacturer oversight and this makes them perfect for outsourcing to stability experts who understand the ICH Guidelines inside and out.
We have a range of walk-in rooms and cabinets and can provide dedicated storage if required. Offering all the typical ICH conditions, accelerated studies and can assist with a wider range of environmental conditions, photostability and thermal cycling studies.
Complete Sample Management
State of the art LIMS help manage your samples and pull calendars. Room performance and inventory reports can be provided with a few clicks of a mouse.
Microbiology and Sterility Testing
Microbiology and Sterility testing being provided by your outsourced stability storage partner can be an advantage. Samples can be moved from the stability chamber directly to the microbiology laboratory, reducing the risk to samples by limiting transportation.
Redundancy and Back up
Back up Generators are installed to preserve the integrity of the sample storage area in the event of a power loss. Walk in rooms and cabinets are validated across a range of temperatures to provide redundancy in the unlikely event of a room failure.
Disaster Recovery EN 22301
Outsourced Stability Storage providers can be engaged to assist with Business Continuity in the event of a crisis which impacts on Stability or controlled storage.
The requirements mean having a long-term relationship with a strategic partner you trust. Things to check for when choosing an outsourced Stability Storage provider:
- GMP/GLP Compliance
- Knowledge of Regulations
- Adaptability to suit your specific needs with bespoke study types
- An exemplary track record and transparency about activities
For more information on Outsourced Stability Storage or Microbiology Testing contact us on +44 (0) 115 973 9012 or email email@example.com.