Standard Operating Procedure for Equipment Calibration

Purpose

The purpose of this SOP is to establish guidelines for calibrating equipment used in warehouse operations within the pharmaceutical facility to ensure accuracy, reliability, and compliance with regulatory requirements.

Scope

This SOP applies to all personnel involved in the calibration, maintenance, and use of equipment critical to warehouse operations, including measuring devices, scales, temperature sensors, and monitoring systems.

Responsibilities

• Warehouse Manager: Overall responsibility for ensuring compliance with equipment calibration procedures and maintaining calibration records.
• Quality Assurance Department: Responsible for establishing calibration schedules, performing equipment calibrations, and verifying calibration results.
• Equipment Custodians: Responsible for maintaining equipment in a calibrated state, scheduling and facilitating calibration activities, and documenting calibration records.
• Technical Personnel: Responsible for performing calibration activities, conducting adjustments or repairs as needed, and ensuring the accuracy and reliability of calibrated equipment.

Procedure

1. Equipment Identification and Classification:
   • Identify all equipment critical to warehouse operations that require calibration to ensure accurate and reliable performance.
   • Classify equipment based on criticality, usage frequency, impact on product quality, and regulatory requirements to determine calibration frequency and priority.
   • Maintain an equipment inventory list that includes details such as equipment name, model number, serial number, location, calibration schedule, and calibration history.
2. Calibration Schedule and Planning:
   • Develop a risk-based calibration schedule specifying the frequency and intervals for calibrating each piece of equipment based on regulatory requirements, manufacturer recommendations, and operational considerations.
   • Coordinate calibration activities in advance, considering factors such as equipment availability, production schedules, and downtime impacts to minimize disruptions to warehouse operations.
   • Notify relevant personnel of upcoming calibration activities, including equipment custodians, operators, and maintenance staff, to ensure their cooperation and support.
3. Calibration Execution and Documentation:
   • Perform calibration activities using calibrated reference standards, equipment, and procedures specified by manufacturers or recognized calibration laboratories.
   • Document calibration procedures, measurements, adjustments, and results in calibration records or logbooks, including details such as date, time, personnel involved, and any deviations or observations noted during the calibration process.
   • Label calibrated equipment with calibration stickers or tags indicating the calibration date, next calibration due date, and equipment status.
4. Calibration Verification and Review:
   • Verify the accuracy and reliability of calibrated equipment through performance checks, comparison with reference standards, and validation of measurement results.
   • Review calibration records and documentation to ensure completeness, accuracy, and compliance with established procedures and regulatory requirements.
   • Address any discrepancies, out-of-tolerance conditions, or non-conformities identified during calibration verification promptly, including initiating corrective actions and re-calibrating equipment as needed.

Abbreviations

• SOP: Standard Operating Procedure

Documents

• Equipment Calibration Schedule
• Calibration Procedure Manual
• Calibration Records and Logbooks
• Calibration Certificates
• Calibration Verification Reports

SOP Version

Version 1.0