In-Process Control Procedure in Pharmaceutical Industry
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 .It may include control of equipment and environment too. 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.
Syrups and Suspensions:
1. Drug contents determination.
2. Assay of active ingredients.
3. pH.
4. Weight per ml.
5. particle size
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.
Injectables:
1. Clarity test.
2. pH.
3. Pyrogen test ( endotoxin test)
4. osmolality test.
5. Leakage test.
6. particulate matters.
7. Assay of active ingredients.
References:
21 CFR 211.110 Sampling and testing of in-process materials and drug products.
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