Page 84 - Pharmaceutics III_ 02-06-01304_Fall 2025_ Pharm D_Electronic book
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Parameter Stage Acceptance Criteria
Blend uniformity Pre-compression RSD < 5 %
Hardness Compression 5–8 kg
Weight variation Compression ±5 %
Dissolution Finished product ≥85 % in 30 min
Coating Process Validation Example:
• Target weight gain: 3 %.
• Inlet temperature: 45 °C ± 2.
• Pan speed: 10 rpm ± 1.
• Acceptance: uniform color, no defects.
Annual Product Review (APR):
• Trend analysis of production and testing data.
• Complaints, deviations, and stability results summarized.
• Recommendations for process improvement.
Handling of Returned Goods:
• Evaluated for tampering, storage condition, and expiry.
• Decision: reprocess, rework, or destroy.
• Recorded in return goods logbook.
Vendor Qualification:
• Audit of raw material suppliers.
• Evaluate GMP compliance, testing capabilities, consistency.
• Approved supplier list maintained.
Cleaning Agent Validation:
• Verify cleaning solution residue below permissible limits.
• Analytical methods validated for sensitivity.
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