In-Process Tests and Final Product Quality Control Tests

• In-Process Quality test and Final Product Quality Control Tests ensure product consistency during manufacturing by monitoring critical parameters like weight, hardness, and moisture.
• In-Process Quality test and Final Product Quality Control Tests also verify finished product quality before release.

In-Process Quality Tests:

1. Weight Variation:

   • Measures the consistency of capsule fill weight.
   • Ensures uniform dosing of the drug.

2. Seal Integrity:

   • Assesses the sealing of the capsule shell to prevent leaks.

3. Moisture Content:

   • Monitored to ensure the gelatin shell remains pliable but not overly moist.

Final Product Test:

1. Appearance:

   • Inspects capsules for uniformity in color, shape, and size.

2. Disintegration Test:

   • Determines the time required for the capsule shell to break down in simulated gastric or intestinal fluids.

3. Dissolution Test:

   • Measures the rate at which the drug is released from the capsule.

4. Content Uniformity:

   • Confirms that each capsule contains the labeled amount of drug within acceptable limits.

5. Microbial Testing:

   • Ensures the absence of microbial contamination.

6. Stability Testing:

   • Evaluates the shelf life of capsules under accelerated and long-term conditions.

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