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Microbiological Control:
• Environmental monitoring: settle plates, air samplers, surface swabs.
• Alert and action limits defined.
• Personnel monitoring (glove prints).
Tablet Coating Equipment Cleaning:
• Dismantle spray gun, pan, ducts.
• Rinse → Detergent wash → Final rinse → Dry.
• Visual inspection and swab testing.
Sampling of Tablets for Testing:
• Random samples taken from different locations of batch.
• Minimum number: 20 units for weight variation, 6 for disintegration, 10 for dissolution.
Retention Samples:
• Double quantity of sample retained (one for control, one for reanalysis).
• Stored at 25 °C / 60 % RH for shelf life + 1 year.
Common Regulatory References:
• USP <701> Disintegration.
• USP <711> Dissolution.
• USP <905> Content Uniformity.
• BP Appendix XII: Tablet testing.
ICH Guidelines Summary:
Guideline Title Purpose
Q1A(R2) Stability testing Shelf life assignment
Q2(R1) Validation of analytical methods Accuracy, precision, linearity
Q3A/B Impurities Limits and control
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