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• Avoid dust explosion: use grounded equipment and dust collectors.
• Handle flammable solvents (IPA, acetone) in explosion-proof rooms.
• Provide fire extinguishers (CO₂ type) and emergency exits.
Occupational Health Monitoring:
• Noise level < 85 dB.
• Dust concentration below occupational exposure limits (OEL).
• Regular health screening for operators handling potent compounds.
Waste Management (Detailed):
Type Disposal Method
Solid waste Incineration or authorized disposal
Liquid waste Neutralization, biological treatment
Packaging waste Recycling after defacing labels
Expired product Destroy under QA supervision
Documentation Hierarchy:
1. Quality Manual.
2. Validation Master Plan.
3. Standard Operating Procedures (SOPs).
4. Specifications and Test Methods.
5. Batch Manufacturing Records.
6. Log Books and Reports.
Good Laboratory Practices (GLP):
• All analytical instruments calibrated.
• Reference standards traceable to pharmacopeia.
• Retention samples stored for reanalysis.
Tablet Process Validation Example:
Drug: Paracetamol 500 mg tablet.
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