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Specifications: Hua Yin May 2014
Specifications: Hua Yin May 2014
Specifications
Hua YIN
Specification
Deficiencies
Review tips
Confirm the quality, rather than fully characterize the API or the
FPP
Microbial limits
Any impurity
The dissolution limits at release and shelf life should be the same.
A limit of NLT 80% (Q) in 15min should be set for both release
and shelf life as for the BCS class 3 biowaiver.
Note that there are specific SST limits for EP and USP methods. If
these methods are adopted, the SST requirements should apply.
Answer: no
The specification should include all standard drug product tests and
limits for that dosage form
E.g. solid orals: description, identity, uniformity of dosage units (CU
or MU), assay, related compounds, dissolution, microbial limits...
FPP User
RoS Specific
manufacturer’s monograph specific
API tests
tests
specification
QIS
Review as per
FPP manufacturer’s •Compendial monograph
Signed and dated •generic guide
specification •ICH Q6A, Q3B
Review the
Compare the •Specific dosage form
summary in QIS •specific test as per the
comment manufacturing process