Standard Operating Procedure for Premises and Facility Management in Otic Manufacturing Unit
1) Purpose
To ensure that the premises and facilities used for manufacturing Otic (Ear) Dosage Forms are maintained in a clean, organized, and compliant manner to prevent contamination and ensure product quality.
2) Scope
This SOP applies to all areas within the manufacturing facility where Otic dosage forms are manufactured, including production, storage, and utility areas.
3) Responsibilities
Facility Manager: Responsible for overall premises and facility management.
Production Supervisor: Responsible for ensuring cleanliness and orderliness during production.
Maintenance Team: Responsible for timely maintenance and repairs of facility infrastructure.
4) Procedure
4.1 Cleaning and Disinfection
4.1.1 Routine Cleaning
4.1.1.1 Establish a cleaning schedule for all areas, including daily, weekly, and monthly tasks.
4.1.1.2 Use approved cleaning agents and methods for different surfaces.
4.1.2 Disinfection
4.1.2.1 Perform regular disinfection of critical areas and surfaces using appropriate disinfectants.
4.1.2.2 Ensure disinfection procedures are validated and documented.
4.2 Pest Control
4.2.1 Pest Monitoring
4.2.1.1 Implement a pest control program with regular monitoring and inspections.
4.2.1.2 Take corrective
4.2.2 Pest Prevention
4.2.2.1 Seal entry points and use physical barriers to prevent pest entry.
4.2.2.2 Train personnel on pest awareness and prevention measures.
4.3 Facility Maintenance
4.3.1 Equipment and Infrastructure
4.3.1.1 Schedule and perform preventive maintenance for all critical equipment and utilities.
4.3.1.2 Respond promptly to equipment breakdowns to minimize downtime.
4.3.2 Facility Repairs
4.3.2.1 Maintain a log of facility repairs and improvements.
4.3.2.2 Ensure repairs are conducted by qualified personnel and comply with safety standards.
5) Abbreviations, if any
SOP: Standard Operating Procedure
GMP: Good Manufacturing Practices
6) Documents, if any
Cleaning and disinfection records
Pest control reports
Maintenance and repair logs
7) Reference, if any
GMP guidelines for facility management in pharmaceutical manufacturing
8) SOP Version
Version 1.0