STABILITY STUDIES
YOUR SUPPORT TO DETERMINE THE LIFECYCLE OF PHARMACEUTICAL PRODUCT
Our partnering stability testing laboratories are equipped with a wide range of analytic techniques. The experienced team of specialised professionals helps our partners to determine the shelf-life of their products. We offer stability testing services at competitive package.
We provide accelerated studies and on-going stability programmes according to the procedures and requirements agreed upon with the partners: the stability testing of bulk or final products through to in-use stability studies, stability monitoring of post-marketing batches (on-going stability testing) and testing in connection with variations.
Legislation
- The requirements of in-use stability testing are described in Guideline CPMP/QWP/2934/99 issued by the European Medicines Agency (EMA).
- Notes for guidance on Development pharmaceutics (CPMP/QWP/155/96), Stability testing of existing active substances and related finished products (CPMP/QWP/556/96) and Stability testing of new drug substances and products (CPMP/ICH/2736/99).
Analytical procedures
- Description and full validation
- Testing and monitoring changes in physical, chemical, and microbial characteristics
- Elimination of impurities that may be formed during the shelf life
- Product development testing to assess the physical, chemical, therapeutic stability of the product
- QP interpretation of OOx results (OOS, OOT, OOE)
Testing design
- To define in-use shelf life, the framework for selection of batches, storage conditions, parameters, procedures etc.
- Test parameters: physical (colour, clarity, closure integrity, particulate matter, particle size), chemical (active substance assay(s), antimicrobial preservative and antioxidant content(s), degradation product level(s), pH) microbial (total viable count, sterility).
Summary
- Shelf-Life Expiry Date Determination: at normal and accelerated conditions
- Storage Conditions Recommendation
- Packaging Material Selection for transportation and storage
- Labelling of the primary container and labelling of the secondary container
- Summary of Products Characteristics (SmPC)
- Patient Information Leaflet (PIL)