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3. Finished-product testing (physical + chemical).
4. Documentation and validation.
5. Stability and shelf-life assignment.

Good Manufacturing Practices (GMP) for Solid Dosage Forms:
Personnel: properly trained, wearing protective garments, free from infectious diseases.
Premises:

• Smooth, washable surfaces.
• Air-handling units to control dust and humidity.
• Segregation of raw materials and finished products.
Equipment: regularly cleaned, calibrated, and maintained.
Documentation: batch production records, equipment logs, cleaning records.

Validation in Tablet and Capsule Manufacture:

1. Process validation: proves that process consistently yields a product meeting its
specifications.

2. Cleaning validation: ensures absence of cross-contamination between batches.

3. Analytical-method validation: confirms accuracy, precision, specificity, linearity, and
robustness of analytical tests.

Environmental Requirements:
• Temperature = 20 – 25 °C.
• Relative humidity = 45 – 55 %.
• Differential air pressure between areas to prevent contamination.

Common Problems During Capsule Manufacturing:

Problem Possible Cause Corrective Action

Shell softening High humidity Dehumidify area, store properly

Shell brittleness Low humidity Condition shells at 40–60 % RH

Filling variation Poor flow Add glidant, adjust machine

Powder leakage Improper lock Adjust cap–body fit

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