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.