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Stability Studies

Chemistry Lab with Computerised Analysers

Stability Studies and Storage Testing

QCNW offer a range of cGMP stability studies for pharmaceutical products

  • Shelf Life Evaluation of Finished Products
  • In-Use Shelf Life Evaluation of Finished Products
  • Shelf Life Evaluation of Clinical Trial Products
  • Extended Shelf Life Evaluation of Aseptically Prepared Medicines

Stability Study Set Up

  • We can design stability study protocols based on customers’ requirements
  • We can develop and validate analytical methods to be ‘stability indicating’

Stability Study Sample Management

  • We can take responsibility for the storage of samples under ICH conditions, either on site at QCNW or at an offsite storage facility.

Stability Study Testing

  • We can perform a wide range of chemical and physical tests required for the intended stability study
  • We can perform testing to the ICH Harmonized Tripartite Guideline, Stability Testing of New Drug Substances and Products – Q1A(R2)
  • We can perform testing to the NHS Pharmaceutical Quality Assurance Committee guidelines – Yellow Cover Document, Standard Protocol for Deriving and Assessment of Stability – Aseptic Preparations

Stability Study Reporting

  • We can provide one to one support, advice and feedback throughout the stability study
  • We can tailor the reporting to the customers needs, reporting after each time point, providing interim reports and final study reports

We can manage the stability study from start to finish.