Information on the stability of a product forms a vital part of any regulatory
submission. Our experience in conducting stability studies, combined with our
analytical method development expertise, places Huntingdon Life Sciences at
the forefront as a service provider.
Up to date technical capability, high standard versatile facilities including
five controlled environment walk-in rooms provide an ideal environment to evaluate
your product effectively at various standard VICH conditions.
In addition a selection of controlled environment cabinets (500 litre and 200
litre capacities) provide bespoke conditions, storage at sub-zero temperatures
and VICH compliant photostability testing.
- Stability trials for formulation development
- Identification of impurities and degradation products –VICH GL 10,
GL 11
- Evaluation of residual solvents – VICH GL 18
- Photostability testing –VICH GL 5
- Stability trials for product licence applications – VICH GL 3, GL
17
- Post approval stability trials – VICH GL 3, GL 17
- Stability of medicated pre-mixes – VICH GL 8
- Shelf life predictions using linear Arrhenius models
Our pharmaceutical analysis department operates in compliance with current
GMP regulations, as they relate to quality control laboratories.
We are subject to regular GMP compliance inspections by the US (FDA) and EU
(UK MCA) authorities and we are approved for nomination as a contract acceptor
on product licences.
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