1) SOP for Equipment Calibration and Maintenance

2) Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the regular calibration and maintenance of equipment used in pharmaceutical manufacturing to ensure accuracy, reliability, and compliance with regulatory standards.

3) Scope

This SOP applies to all personnel involved in the calibration and maintenance of equipment within the pharmaceutical manufacturing facility.

4) Responsibilities

• Maintenance personnel are responsible for performing the calibration and maintenance activities as per this SOP.
• Quality Assurance (QA) personnel are responsible for verifying that calibration and maintenance activities are performed correctly and according to schedule.
• Supervisors are responsible for overseeing the calibration and maintenance process and ensuring compliance with this SOP.

5) Procedure

1. Preparation
   1. Review the equipment calibration and maintenance schedule to identify the equipment due for calibration or maintenance.
   2. Ensure that all necessary tools, calibration standards, and documentation are available and meet the required specifications.
   3. Wear appropriate personal protective equipment (PPE) as specified in the SOP.
2. Calibration Procedure
   1. Turn off and disconnect the equipment from the power supply before starting calibration.
   2. Clean the equipment to remove any dust or residues that might affect the calibration process.
   3. Set up the calibration standards according to the manufacturer’s instructions or standard operating procedures.
   4. Perform the calibration using the specified methods and record the calibration results in the calibration logbook.
   5. Compare the calibration results against the acceptance criteria and adjust the equipment as necessary to meet the required standards.
   6. Label the equipment with the calibration status, including the date of calibration, next due date, and the name of the person who performed the calibration.
3. Maintenance Procedure
   1. Turn off and disconnect the equipment from the power supply before starting maintenance.
   2. Clean the equipment to remove any dust or residues that might affect the maintenance process.
   3. Inspect the equipment for any signs of wear, damage, or malfunction.
   4. Replace or repair any damaged or worn parts as per the manufacturer’s recommendations or standard operating procedures.
   5. Lubricate moving parts if necessary, following the manufacturer’s guidelines.
   6. Perform a functional test to ensure the equipment operates correctly after maintenance.
   7. Record the maintenance activities in the maintenance logbook, including the date, details of the work performed, and the name of the person who performed the maintenance.
4. Verification and Documentation
   1. QA personnel should review the calibration and maintenance records to ensure they are complete and accurate.
   2. Document any deviations or issues identified during calibration or maintenance and initiate corrective actions if necessary.
   3. Maintain a record of all calibration and maintenance activities, including calibration certificates, in the equipment logbook.
5. Calibration and Maintenance Schedule
   1. Develop and maintain a calibration and maintenance schedule for all equipment based on manufacturer’s recommendations, regulatory requirements, and company policies.
   2. Review and update the schedule regularly to ensure it remains current and accurate.
6. Training
   1. Ensure that all personnel involved in calibration and maintenance activities are trained and competent in the procedures outlined in this SOP.
   2. Maintain training records for all personnel involved in calibration and maintenance activities.

6) Abbreviations, if any

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• PPE: Personal Protective Equipment

7) Documents, if any

• Calibration Logbook
• Maintenance Logbook
• Calibration Certificates
• Equipment Logbook

8) Reference, if any

• Current Good Manufacturing Practice (cGMP) guidelines
• Manufacturer’s equipment manuals and guidelines
• Company-specific calibration and maintenance guidelines

9) SOP Version

Version 1.0