The Importance of a Stability Storage Back-Up Plan


Stability Storage – Disaster Recovery Plans

How do you handle unforeseen events that can impact your stability study?

Unfortunately, extreme weather, flooding, fire, power outages, software glitches, and human error are very real possibilities.

Pharmaceutical studies are complicated endeavors. The capital investment, time, and scientific expertise required are considerable. Disruption or delays to a project can result in months or years of lost research, time, financial resources, lost revenue due to a delayed product launch.

How to Mitigate Threats to Your Studies

Identify Risks Early

  • Loss of valuable products in long-term storage studies
  • Threats to stability trial continuity – power outages, weather, disaster, etc.
  • Productivity impacts – downtime, repairs, staffing challenges
  • Loss of revenue – delayed regulatory approval and go-to-market timelines

Create a Back-Up Plan

Creating contingency plans to address these risks at the start of your study will help ensure continuity and project success.  Partnering with a qualified stability storage vendor will provide your team “second site” contingencies, ensuring the uninterrupted progress of your study.

Choosing the Right Partner

When choosing a storage service partner, key areas to review are:

  • Quality systems
  • Staffing capacity and expertise
  • End-to-end project management experience
  • Customization capacity
  • Corrective and preventive actions systems
  • Document control methods
  • Successful storage stability study track-record
  • Responsiveness/customer service

Purple Diamond – The Innovation center has proven expertise in stability storage across a wide variety of industries. We understand the complex stability storage requirements, and our facility is fully validated, compliant, and fully secure.

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