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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).

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)

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)

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)
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