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API
Ajmal Nasir
Ph.D.
Q1A (R2)
This Guideline provides recommendations on
stability testing protocols including temperature,
humidity and trial duration for climatic Zone I and
II.
Furthermore, the revised document takes into
account the requirements for stability testing in
Climatic Zones III and IV in order to minimise the
different storage conditions for submission of a
global dossier.
DRUG STABILITY
Economic controls
Legal Compliance
VARIABLES EFFECTING STABILITY
Formulation Batch To Batch Variability
suspensions)
dissolution profile)
registration purposes.
should be examined to ensure that the material is still in compliance with the
specification and thus suitable for use in the manufacture of a given drug
product.
Re-test period- The period of time during which the drug substance is
expected to remain within its specification and, therefore, can be used in the
manufacture of a given drug product, provided that the drug substance has been
stored under the defined conditions. After this period, a batch of drug substance
destined for use in the manufacture of a drug product should be re-tested for
container label.
API Stress Testing
analytical method
API Stress Testing
The stress stability condition is more severe than normal
Oxidation
Photolysis
testing
API Stress Testing
[ICHQ1A]
Pilot batches must be of the same synthesis route, and with method of
manufacture and procedure which simulates the final process for production
batches .
Method should be stability indicating If API is low soluble and micronized, and the
FPP is low dose, PSD is critical for this API due to potential of settling on storage
If low soluble API and there is evidence of polymorph stability issue, polymorphic
LONG TERM:
ACCELERATED:
INTERMEDIATE :
unless justified
The storage condition on the label should be as described for
the storage condition of long term study Example.
Extrapolation of data
Batch size
Mass balance