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• Investigation initiated immediately.
• Phase I: laboratory error evaluation.
• Phase II: full-scale investigation including process review.
• Batch disposition decided by QA.
Product Complaints:
• All complaints logged with product name, batch number, and details.
• Investigation initiated within 24 hours.
• Trend analysis performed to identify recurrence.
Product Recall:
• Classified as Class I (serious), II (temporary), III (minor).
• Communication with regulatory authority mandatory.
• Mock recalls conducted periodically.
Self-Inspection and Internal Audits:
• Conducted quarterly by trained personnel.
• Audit checklist covers GMP compliance, documentation, safety.
• Corrective actions verified within 30 days.
Training and Qualification:
• Initial and periodic training for all employees.
• Records maintained for each session.
• Training effectiveness evaluated by test or observation.
Calibration and Maintenance:
• All measuring devices calibrated periodically.
• Preventive maintenance schedule maintained.
• Equipment breakdown recorded and investigated.
Safety in Tablet Manufacturing:
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