A set of originally five guidelines (Q1A to Q1F)
defining
-
General aspects of stability testing (storage
conditions, batch size and number, length of
time...)
Photostability
Application to new dosage forms
Possibilities for reduced test designs
(bracketing and matrixing)
Statistical evaluation of stability data
and possibilities for extrapolation
Storage conditions for stability testing in
climatic zones III and IV (withdrawn)
ICH Q 1 A (R2) – Scope
For new API and related medicinal products
To provide evidence on how the quality of an
API/finished product changes with time under
the influence of environmental factors such
as temperature, humidity and light and to
establish a re-test period/shelf-life for the
API/finished product
ICH Q 1 A (R2) – In a Nutshell
Stress testing required for API
Long-term and accelerated testing required for API and
product, where necessary intermediate testing
Minimum of three representative batches
Testing over a minimum of 12 months at LT and 6 months at
accelerated conditions (with defined testing frequency)
Storage conditions for the “general case”, aqueous products
in semi-permeable containers, products to be stored in a
refrigerator and a freezer
Stability commitment
ICH Q 1 B – In a Nutshell
Describes requirements on photostability testing and defines
light exposure to be applied
To be tested on API
if not photosensitive, no further testing
required
If photosensitive, to be continued on exposed finished
product and product in primary package, product in
marketing package, where relevant
Where necessary, impact of light during manufacturing
process to be evaluated
Confirmatory testing required, where applicable
ICH Q 1 C – In a Nutshell
Additional guidance to ICH Q1 A(R2) on new
dosage forms (“line extensions”) for new
substances
Reduced requirements as regards time to be
covered at LT storage conditions at time of dossier
submissions
ICH Q 1 D – In a Nutshell
Describes possibilities to apply reduced test designs, i.e.
bracketing and matrixing
Defines situations where reduced testing can be applied
without additional justification, with justification or where it is
not applicable
Bracketing: testing of extremes only
Matrixing: testing of a different samples of factor
combinations at different time points during the study
Provides example designs
ICH Q 2 – Analytical Validation will continue....next post..
