Justification for bringing back in-house Stability Storage trials
Stability storage is where samples or finished products are placed in specific environmental conditions, albeit temperature and humidity or cold and frozen climate. This is undertaken to ensure that the Active Pharmaceutical Ingredients (API) and the packaging do not deteriorate over time when exposed to those external climatic conditions.
Stability storage essentially assesses the product's shelf life and the finished product packaging; given those environmental conditions, the product performs as required. The process of stability storage is critical in launching a product to market, and any delays to this can have substantial financial consequences for a pharmaceutical company.
Why do you need correct Stability Storage?
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration.
The ICH guidelines are harmonized standards that protect human rights, safety, and welfare, eliminating their exposure to investigational products, improving the quality of data, and speeding up the marketing of new drugs.
Therefore, it is more important than ever to choose the right partner for your stability storage needs and requirements. Pharmaceutical companies generally have two main options for conducting their stability storage studies:
- Outsource the storage of samples to a third-party provider
- Undertake storage themselves in-house
Whilst each option has its advantages and disadvantages, the CRS Pharma Solutions team has noticed a shift in the mindset of the customers as they choose to undertake storage in-house. Below we will discuss the reasons why many businesses prefer their storage in-house.
Can in-house cold stores help you financially?
Outsourcing storage companies, of course, will have their methods of how they charge clients, whether per stability study, per basket or some other volume charge. Typically, a unit charge is incurred monthly, and over time, as the number of stability studies, samples, or volumes increase, those monthly charges would also increase.
There does come a 'tipping' point where financially, it does make more sense to bring the storage back in-house rather than continue to outsource. This is where CRS Pharma Solutions can assist you with your stability storage studies or cold store units. We supply, install and commission a variety of controlled environmental equipment, including:
- Refrigerated rooms
- Cold stores for bulk and pallet storage
- Freezer rooms
- Stability storage rooms
- ATEX chambers
Our customers can choose whether to purchase the equipment outright or lease it over a long-term basis for a weekly or monthly fee. This proposition allows many businesses to manage costs more effectively. Clients can pay a weekly/monthly fee regardless of the amount of the stored products. This assists greatly with the financial management of stability studies as there are no variable costs.
Stay in control of your production
More of our pharmaceutical clients are announcing that they prefer to keep control of the stability or bulk storage samples. These samples can be worth millions of pounds, giving companies the confidence to know that they remain on-site and adhere to their Standard Operating Procedures (SOPs).
With the logistics of couriers, especially if the product is regularly shipped in and out, it is not always the best practice to store samples off-site, so keeping products on-site can be more effective.
Why choose CRS Pharma Solutions?
Many outsourced storage providers charge per stability storage study. Depending on the number of studies a pharmaceutical company holds, they can obtain multiple weekly returns, all incurring a courier charge. The costs, of course, can be mitigated if the storage is conducted at the pharmaceutical site.
When equipment is leased from CRS Pharma Solutions, those costs include 24/7/365 emergency call-out response for all units within the UK and Ireland, and a Preventative Maintenance Inspection (PMI) is included to give our clients peace of mind.
All of our equipment supplied to the pharmaceutical, healthcare and medical industries are 'pharma-spec' and include twin, run and standby refrigeration systems and multi-functional alarms (local and remote) with the equipment validated to the ICH standards.
Have a browse through our website, or email us at salesadmin@CRS.ie if you would like to learn more about how CRS Pharma Solutions can support you with your controlled environmental storage solutions.
