In-Process and Final Product Quality Control Tests

• In-Process and Final Product Quality Control Tests are essential for ensuring pharmaceutical product quality.
•  In-Process and Final Product Quality Control Tests check parameters during manufacturing process and confirm safety, efficacy, and compliance before release.

In-Process Quality Tests:

1. Weight Variation:

   • Ensures consistent weight across capsules.
   • Conducted by weighing individual capsules and comparing with average weight.

2. Moisture Content:

   • Measured to ensure capsules are neither too brittle nor too soft.

3. Appearance:

   • Visual inspection for uniformity in color, size, and absence of defects.

Final Product Quality Control Tests:

1. Disintegration Test:

   • Determines the time required for capsules to break down in a specified medium (usually simulated gastric or intestinal fluids).

2. Dissolution Test:

   • Measures the rate and extent of drug release from the capsule.

3. Content Uniformity:

   • Ensures uniform drug distribution within capsules.

4. Stability Testing:

   • Capsules are subjected to accelerated and long-term stability studies under varying conditions (temperature, humidity) to assess product shelf life.

5. Microbial Testing:

   • Evaluates the microbial load to ensure the absence of harmful bacteria or fungi.

6. Seal Integrity:

   • For liquid-filled capsules, checks for leaks or breaches in the capsule shell.

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