IPC TESTS FOR VARIOUS DOSAGE FORMS
In-Process control procedure*(IPC TESTS FOR VARIOUS DOSAGE FORMS) in pharma
These are
checks that are carried out before the manufacturing process is completed.
The function of in-process controls is monitoring in order to comply with
the specifications. This may include control of equipment and environment
too. In-process materials should be tested for identity, strength, quality and
purity as appropriate and approved or rejected by the quality control unit
during the production process. Rejected in-process materials should be
identified and controlled under a quarantine system designed to prevent their
use in manufacturing. Written procedure should be established and followed
that describe the in-process controls and tests.
IPC TESTS
FOR VARIOUS DOSAGE FORMS:
Tablets:
1. Drug
contents determination.
2. Moisture
contents of granules.
3. Assay
of active ingredients.
4. Weight
variation of uncoated tablets.
5. Hardness
test.
6. Disintegration
test.
IPC TEST
FOR SYRUPS AND SUSPENSION:
1. Drug
contents determination.
2. Assay
of active ingredients.
3. pH.
4. Weight
per ml.
5. particle
size
--IPC TEST
FOR SEMI- SOLIDS:
1. Drug
contents determination.
2. Assay
of active ingredients.
3. Uniformity
and homogeneity test.
4. Viscosity
and specific gravity test.
5. Filling
test.
--IPC TEST
FOR INJECTABLES:
1. Clarity
test.
2. pH.
3. Pyrogen
test.
4. Stability
test.
5. Leakage
test.
6. particulate
matters.
7. Assay of
active ingredients.
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