Professional Documents
Culture Documents
Linda Margata
▪ Defects in pharmaceutical product quality can be encountered
such as low manufacturing process yield or, more dangerously,
some which may affect the therapeutic performance of the drug
Quality by (or both).
QTPP CQA ▪ QTPP is initially defined, based upon properties of the drug
substance, characterization of the reference product (if it exists),
and intended patient population.
▪ QTPP for immediate release tablets may include the following
requirements: assay, content uniformity, and dissolution,
hardness, friability, size
▪ Identification of CQA
Formulation ▪ Bioavailability or bioequivalence studies
Development ▪ Any special design features of the drug product (e.g., tablet
score line, overfill, anticounterfeiting measure as it affects the
drug product) should be identified
▪ In general, use of an overage of a drug substance to compensate
for degradation during manufacture or a product’s shelf life, or
to extend shelf life, is discouraged.