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Drug Product
Cynthia 260110142003
Abdullah Azim 260110142007
Nor Izzati 260110142008
Sanjiv Menon 260110142010
PHOTOSTABILITY TESTING
For critical dosage forms (e.g., prolonged release forms) or when the
drug substances are known to be unstable, stability data on three
primary batches are to be provided. Two of the three batches should
be at least of a pilot scale; the third batch may be smaller.
SPECIFICATIONS
TABLETS
CAPSULE
EMULSION
ORAL SOLUTIONS AND SUSPENSION
ORAL POWDER FOR RECONSTITUTION
METERED DOSE INHALATION AND NASAL AEROSAL
NASAL SPRAY
TOPICAL, OPHTHALMIC
SUPPOSITORIES
SMALL VOLUME PARENTALS
LARGE VOLUME PARENTALS
DRUG ADMIXTURE
TESTING PARAMETERS
The Microbial quality dose sterile and non sterile dosage forms should be
controlled.
Challenge test should be carried out at least at the beginning and the
end of the shelf life
Such test would normally performed as part of development programme
It is not expected that every test listed be performed at each time point
Test for pyroxene and bacterial endotoxins may be limited to time of
release
The level of microbiological contaminations in liquid packed containers
with flexible seals
The storage orientation of the product upright versus inverted may need
to be included in a protocol where there has been change