Page 78 - Pharmaceutics III_ 02-06-01304_Fall 2025_ Pharm D_Electronic book
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Documentation and Records:
• Batch Manufacturing Record (BMR).
• Batch Packaging Record (BPR).
• Equipment Cleaning Log.
• In-process and finished product test reports.
• Deviations and corrective actions (CAPA).
Change Control and Validation:
• Any change in process or material must be evaluated for impact on quality.
• Revalidation if significant change occurs.
Tablet Coating Process Validation:
• Critical parameters: spray rate, air temperature, atomization pressure, pan speed.
• Acceptance criteria: uniform film, no defects, reproducible thickness.
Cleaning Validation:
• Ensure residues of previous batch below acceptable limits (mg/cm²).
• Swab and rinse samples analyzed.
Acceptance criteria:
• <10 ppm carryover or <1/1000 of therapeutic dose.
Stability Studies – Documentation:
• Protocol approved before study.
• Includes sample quantity, test intervals, storage conditions.
• Reports retained as part of regulatory submission.
Waste Management in Tablet Production:
• Segregation of solid, liquid, and chemical waste.
• Incineration or neutralization as per environmental guidelines.
• Spillage control procedures mandatory.
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