Stability studies are an essential component of pharmaceutical development, commercialization and supply chain management.

They can allow the evaluation of active pharmaceutical ingredient (API) stability or drug product stability under the influence of a variety of environmental factors such as temperature, humidity and light. They can also be used to determine appropriate storage conditions during transport. Data from these studies enable recommended storage conditions, retest intervals and shelf lives to be established.

Verta Life Sciences provide consultancy and management support for stability programs which can include:

  • Design of a stability protocol that satisfies all requirements appropriate to the stage of your product life cycle, incorporating regional and/or global regulatory requirements.
  • Interim stability reports including individual test point results, summaries at specified time periods and graphical trend analysis
  • Final Stability Summary report meeting regulatory and ICH requirements.
  • Thermal cycling study protocols and reports to support supply chain management.
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Stability Support – Case Study
Issue:

A medical device Client needed a stability program design for a new product that would meet regulatory requirements in multiple climatic zones.

Objective:

Design a single stability protocol that could be used for regulatory submissions in multiple climatic zones. Manage the third party stability contractor and provide trend graphs and stability reports as required.

Deliverable:
  • Stability protocol developed that could be used for regulatory submissions in all ICH climatic zones.
  • Management of third party stability contractor was provided through to client’s requested completion date.
  • Interim trend analysis graphs provided at each study time point.
  • Final stability study summary report provided meeting ICH and FDA regulatory requirements.