Standard Operating Procedure for Calibration and Maintenance of Equipment in Otic Manufacturing Unit
1) Purpose
To establish guidelines for the calibration and maintenance of equipment used in the manufacturing, testing, and packaging of Otic (Ear) Dosage Forms to ensure accuracy, reliability, and compliance with regulatory requirements.
2) Scope
This SOP applies to all critical equipment and instruments used in the Otic manufacturing unit, including but not limited to, analytical instruments, production equipment, and monitoring devices.
3) Responsibilities
Maintenance Department: Responsible for performing routine maintenance and calibration activities.
Quality Assurance (QA) Department: Responsible for overseeing the calibration and maintenance program, including scheduling and documentation.
Production Supervisors: Responsible for ensuring equipment readiness and coordinating with maintenance for calibration activities.
4) Procedure
4.1 Equipment Identification
4.1.1 Inventory
4.1.1.1 Maintain an inventory of all equipment requiring calibration and maintenance.
4.1.1.2 Assign unique identification numbers or codes to each equipment for tracking purposes.
4.1.2 Classification
4.1.2.1 Classify equipment based on criticality to product quality and regulatory requirements.
4.1.2.2 Prioritize equipment for calibration and maintenance based on risk assessment.
4.2 Calibration Schedule
4.2.1 Frequency
4.2.1.1 Establish calibration frequencies based on manufacturer recommendations, regulatory requirements, and historical data.
4.2.1.2 Review and update calibration schedules as necessary to ensure compliance.
4.2.2 Calibration Procedure
4.2.2.1 Perform calibration activities according to documented procedures and protocols.
4.2.2.2 Use calibrated standards and traceable references for accurate calibration.
4.3 Maintenance Activities
4.3.1 Routine Maintenance
4.3.1.1 Schedule routine preventive maintenance activities to ensure equipment reliability.
4.3.1.2 Conduct inspections and lubrication as per equipment manuals and SOPs.
4.3.2 Corrective Maintenance
4.3.2.1 Address equipment breakdowns or malfunctions promptly to minimize downtime.
4.3.2.2 Document and investigate root causes of equipment failures for continuous improvement.
4.4 Calibration Records
4.4.1 Documentation
4.4.1.1 Record calibration details including date, technician, results, and any adjustments made.
4.4.1.2 Maintain calibration certificates and calibration history for each equipment.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QA: Quality Assurance
GMP: Good Manufacturing Practices
6) Documents, if any
Calibration schedules
Calibration certificates
Maintenance logs and reports
7) Reference, if any
GMP guidelines for equipment calibration and maintenance in pharmaceutical manufacturing
8) SOP Version
Version 1.0
