SOPs for API Manufacturing V 2.0

To define the procedures for the identification, segregation, labeling, temporary storage, transportation, and disposal of hazardous waste generated in API manufacturing operations in accordance with GMP, CPCB, and environmental safety guidelines.
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To establish a standardized procedure for monthly inspection, annual maintenance, refilling, tagging, and record-keeping of fire extinguishers installed in the API manufacturing facility. This ensures all firefighting equipment is in working condition and accessible during emergencies.
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To define the procedure for the selection, distribution, usage, maintenance, and replacement of Personal Protective Equipment (PPE) in the API manufacturing facility, ensuring protection against occupational health hazards and compliance with safety and GMP guidelines.
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To define a structured process for immediate reporting, thorough investigation, and effective resolution of all workplace incidents and accidents in API manufacturing, including near misses. This SOP ensures compliance with EHS standards, promotes employee safety, and drives continuous improvement through root cause analysis and preventive actions.
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To define the procedure for regular inspection, replenishment, and documentation of First Aid Boxes located across the API manufacturing facility, ensuring they are always equipped with required medical supplies for immediate response to minor injuries or health issues.
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To define the safe entry procedure for confined spaces in the API manufacturing facility. This SOP outlines the required controls, monitoring, PPE, permits, and documentation to prevent accidents, ensure employee safety, and comply with statutory and GMP guidelines.
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