In-Process Control Procedure in Pharmaceutical Industry

IPC are checks that are carried out during manufacturing process running and/or before the manufacturing process is completed. The function of in-process controls is in-process 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

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
4. Stability test
5. Leakage test
6. particulate matters
7. Assay of active ingredients

Read also:

• Batch Production Record in Pharmaceutical Industry
• Subpart of 21 CFR Part 211

References:

• 21 CFR 211.110 – Sampling and testing of in-process materials and drug products