Mitigating Risks in Pharmaceutical Stability Storage

Stability studies represent considerable investment in cost and time. What steps can be taken to mitigate the risks of losing valuable samples in storage due to unforeseen disasters?

06 December 2016

Stability storage and stability studies play a fundamental part in the lifecycle of a pharmaceutical drug product. From preclinical to a marketed product, stability studies play a key role in ensuring the product's safety, efficacy and quality.

Pharmaceutical stability studies are complex and demand considerable investment in cost, time and scientific expertise. Damage to samples placed on storage, or loss of these samples which may have been on storage for a significant period of time (perhaps several years), could represent critical financial loss and disruption to development activities, potentially impacting a product's market launch. This can mean long-term repercussions for the commercial success of the product and ultimately for the company.

But what happens when unforeseen events pose a risk to the continuity of an on-going stability study? Disasters caused by extreme weather,  fire, electrical failures,  power outages, aging equipment, software failure or even earthquakes have the potential to significantly affect stability storage, causing damage or even complete loss of stored samples.

Although stability contingency and disaster recovery storage is not specifically covered in the ICH guidelines relevant to stability studies, ensuring the  continuity of a stability study by putting in place a robust and efficient recovery plan which establishes contingency storage at a second site is an essential requirement for most disaster recovery strategies.

The selection of an experienced stability contingency storage provider is critical to the success of your disaster recovery plan. During this selection of a storage service provider, there are some practical considerations underpinning this process which will help to secure a suitable back-up resource to your existing stability suite. Client audits are an important step to assessing this service provider.

The qualities you should assess your services provider against are:

  • Design and delivery of a customized program
  • Capacity of storage facility
  • Excellence in project management
  • Quality
  • Responsiveness
  • Knowledge and experience of the regulatory Guidance

Ultimately, a successful study comes from a successful collaboration. The information in the stability contingency and disaster recovery plan and resulting stability protocol is paramount to success. It is critical to work closely with your storage provider and ensure good communication between all stakeholders in both organizations for a successful implementation - only with this type of relationship is it possible to mitigate risks to your stability storage operations and ensure the integrity of your stability trials.

To learn more about selecting a stability contingency storage provider and what elements should be considered to ensure the continuity of your studies in the advent of a disaster, download: http://www.intertek.com/knowledge-education/pharmaceutical/stability-contingency-storage-disaster-recovery-wp/

Theresa Russell is the Stability Manager at, Intertek Melbourn, Cambridge, UK. After joining Melbourn Scientific in 2000 as an Analyst and working her way through the ranks she became responsible for the commissioning and operational function of the 8,000sqft GMP dedicated ICH stability storage facility which was launched in May 2015. Over the years, Theresa has facilitated the storage and testing of a large number of stability studies for clients around the globe and has experience over many product types.