Standard Operating Procedure for Equipment Calibration
1) Purpose
The purpose of this SOP is to establish procedures for the calibration of manufacturing equipment to ensure accuracy and reliability in production processes.
2) Scope
This SOP applies to all personnel involved in the calibration of equipment at [Company Name] used for the production of intramuscular, subcutaneous, and intravenous injection products.
3) Responsibilities
The responsibilities of this SOP include:
– Maintenance Personnel: Performing equipment calibration according to the SOP.
– Quality Control (QC) Department: Verifying calibration results.
– Quality Assurance (QA) Department: Reviewing and approving calibration procedures and records.
4) Procedure
4.1 Preparation for Calibration
4.1.1 Identify equipment that requires calibration and the calibration schedule.
4.1.2 Ensure that calibration standards and instruments are available and properly maintained.
4.2 Calibration Process
4.2.1 Perform calibration according to the manufacturer’s instructions and established calibration procedures.
4.2.2 Record calibration data, including the equipment ID, calibration date, and results.
4.2.3 Adjust equipment settings as necessary to meet calibration standards.
4.3 Verification of Calibration
4.3.1 Verify calibration results by comparing them against predefined acceptance criteria.
4.3.2 Investigate and document any deviations or failures.
4.3.3 Recalibrate equipment if acceptance criteria are not met.
4.4 Documentation
4.4.1 Maintain records of all calibration activities, including calibration certificates, data, and any deviations or corrective actions.
4.4.2 Ensure all records are signed and dated by the responsible personnel.
4.5 Calibration Schedule
4.5.1 Develop and maintain a calibration schedule for all equipment requiring calibration.
4.5.2 Ensure calibration is performed at regular intervals and whenever equipment is repaired or moved.
5) Abbreviations, if any
– QA: Quality Assurance
– QC: Quality Control
6) Documents, if any
– Calibration Certificates
– Calibration Data Logs
– Calibration Schedule
7) Reference, if any
– Good Manufacturing Practices (GMP) Guidelines
– International Organization for Standardization (ISO) Standards
– Equipment Manufacturer’s Manual
8) SOP Version
Version 1.0