Standard Operating Procedure for Calibration of Equipment
1) Purpose
The purpose of this SOP is to establish procedures for the calibration of equipment used in the manufacturing process to ensure accuracy, reliability, and compliance with regulatory requirements.
2) Scope
This SOP applies to all equipment within the manufacturing facility that requires calibration to maintain product quality and compliance.
3) Responsibilities
The responsibilities for this SOP are divided among various roles:
3.1 Calibration Technicians:
Responsible for performing calibration activities according to the established procedures.
3.2 Equipment Users:
Responsible for notifying the Calibration Department of any equipment requiring calibration.
3.3 Quality Assurance (QA) Manager:
Responsible for overseeing the calibration program and ensuring compliance with regulatory requirements.
4) Procedure
4.1 Calibration Schedule:
4.1.1 Develop a calibration schedule based on equipment criticality and regulatory requirements.
4.1.2 Ensure all equipment is calibrated at the specified intervals.
4.2 Calibration Procedures:
4.2.1 Use calibrated standards and procedures approved by the Calibration Department.
4.2.2 Perform calibration activities following the manufacturer’s instructions and established procedures.
4.2.3 Record pre-calibration and post-calibration data accurately.
4.3 Documentation and Recordkeeping:
4.3.1 Document all calibration activities in the Calibration Log.
4.3.2 Maintain calibration certificates and records of equipment calibration history.
4.3.3 Review calibration records regularly to ensure compliance with the calibration schedule and accuracy of measurements.
4.4 Out-of-Tolerance Conditions:
4.4.1 Identify
4.4.2 Perform investigations to determine the root cause of out-of-tolerance conditions.
4.4.3 Implement corrective actions to prevent recurrence of out-of-tolerance conditions.
4.5 Calibration Verification:
4.5.1 Conduct verification of calibration results to ensure accuracy and reliability.
4.5.2 Document verification activities and results in the Calibration Log.
4.5.3 Perform periodic audits of the calibration program to ensure ongoing compliance and effectiveness.
5) Abbreviations, if any
QA – Quality Assurance
6) Documents, if any
1. Calibration Schedule
2. Calibration Procedures
3. Calibration Log
4. Calibration Certificates
5. Audit Reports of Calibration Program
7) Reference, if any
1. FDA Guidance on Equipment Qualification
2. ISO 17025 General requirements for the competence of testing and calibration laboratories
8) SOP Version
Version 1.0