Stability Testing
The purpose of stability testing is to
provide evidence that under influence of a variety of environmental
factors how the quality of a drug product varies with time.It helps
to establish a re-test period for the drug substance or a shelf life
for the product and recommended storage conditions.
Stability Testing is categorized in three
different studies.
- Long term /Real-time ICH (nternational
Conference on Harmonisation) stability testing.
- Intermediate
- Accelerated
Real-time ICH stability testing is conducted
at room temperatures to reproduce actual storage conditions.
Accelerated stability testing is carried
out at higher temperatures to simulate long term.
At least three primary batches
of the product should be submitted for testing.
The batches should be manufactured to
a minimum of pilot scale by the same
synthetic route as, and using a method
of manufacture and procedure that simulates the final
process to be used for production batches.
Container Closure System
The stability studies should be conducted
on the drug substance packaged in a container
closure system that is the same as or
simulates the packaging proposed for storage and
distribution.
Specification
Stability studies include testing of
those attributes of the products that are
susceptible to change during storage
and are likely to influence quality, safety, and/or
efficacy. We test your product for
physical and biological change (microbiological attributes).
Testing Frequency
For long-term studies, the frequency
of testing should normally be every
3 months over the first year, every 6
months over the second year, and annually thereafter
through the proposed re-test period.
At the accelerated storage condition,
a minimum of three time points, including the initial and
final time points (e.g., 0, 3, and 6
months).
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