Standard Operating Procedure for Equipment Calibration
1) Purpose
The purpose of this SOP is to establish a procedure for the calibration of equipment used in the manufacturing and testing of pharmaceutical products to ensure accuracy and reliability.
2) Scope
This SOP applies to all equipment requiring calibration within the manufacturing and quality control departments.
3) Responsibilities
The responsibilities for this SOP are divided among various roles:
3.1 Equipment Operators:
Responsible for identifying equipment requiring calibration and notifying the calibration team.
3.2 Calibration Team:
Responsible for performing calibration activities according to the established procedures.
3.3 Quality Assurance (QA) Manager:
Responsible for overseeing the calibration process and ensuring compliance with regulatory requirements.
4) Procedure
4.1 Identification of Equipment:
4.1.1 Maintain a master list of all equipment requiring calibration.
4.1.2 Label each piece of equipment with a unique identification number.
4.2 Scheduling Calibration:
4.2.1 Develop a calibration schedule based on the manufacturer’s recommendations and regulatory requirements.
4.2.2 Notify relevant departments of upcoming calibration activities.
4.3 Calibration Process:
4.3.1 Follow the calibration procedure outlined in the equipment’s operation manual.
4.3.2 Use certified calibration standards and reference materials.
4.3.3 Record calibration data, including pre-calibration and post-calibration results.
4.3.4 Adjust equipment settings as needed to achieve the desired accuracy.
4.4 Documentation and Review:
4.4.1 Document all calibration activities in the equipment’s calibration log.
4.4.2 Review calibration data to ensure compliance with acceptance criteria.
4.4.3 Approve calibrated equipment for use only if it meets the required specifications.
4.5 Handling Out-of-Tolerance Equipment:
4.5.1 Remove out-of-tolerance equipment from service immediately.
4.5.2 Investigate the cause of the out-of-tolerance condition.
4.5.3 Perform necessary repairs or adjustments and recalibrate the equipment before returning it to service.
5) Abbreviations, if any
QA – Quality Assurance
6) Documents, if any
1. Calibration Logs
2. Equipment Operation Manuals
3. Calibration Standards Certificates
7) Reference, if any
1. FDA Guidance on Good Manufacturing Practices (GMP)
2. ISO 17025 General Requirements for the Competence of Testing and Calibration Laboratories
8) SOP Version
Version 1.0
