Standard Operating Procedure for Calibration and Maintenance of Equipment

1) Purpose

The purpose of this SOP is to establish procedures for the calibration and maintenance of manufacturing equipment to ensure accurate and reliable operation, thereby maintaining product quality and regulatory compliance.

2) Scope

This SOP applies to all equipment used in the manufacturing, quality control, and storage of pharmaceutical products within the facility.

3) Responsibilities

The responsibilities for this SOP are divided among various roles:

3.1 Equipment Operators:

Responsible for operating equipment according to SOPs and reporting any issues.

3.2 Maintenance Technicians:

Responsible for performing routine maintenance and calibration.

3.3 Quality Assurance (QA) Manager:

Responsible for overseeing the calibration and maintenance program and ensuring compliance.

4) Procedure

4.1 Calibration of Equipment:

4.1.1 Identify all equipment requiring calibration and establish a calibration schedule.
4.1.2 Use certified calibration standards and equipment.
4.1.3 Document calibration activities, including date, results, and technician performing the calibration.
4.1.4 Label calibrated equipment with the calibration status and next due date.

4.2 Maintenance of Equipment:

4.2.1 Develop a preventive maintenance schedule based on manufacturer recommendations and equipment usage.
4.2.2 Perform maintenance activities as per the schedule, including cleaning, lubrication, and part replacement.
4.2.3 Document all maintenance activities, including date, details of work performed, and technician involved.
4.2.4 Report any equipment malfunctions or issues immediately for corrective action.

4.3 Verification and Validation:

4.3.1 Verify the accuracy of equipment performance post-calibration and maintenance.
4.3.2 Validate equipment performance periodically to ensure it meets operational requirements.
4.3.3 Document validation activities and results.

4.4 Record Keeping:

4.4.1 Maintain calibration and maintenance logs for all equipment.
4.4.2 Store records in a secure and easily retrievable manner.
4.4.3 Review records regularly to identify trends or recurring issues.

5) Abbreviations, if any

QA – Quality Assurance

6) Documents, if any

1. Calibration Schedule
2. Calibration Records
3. Maintenance Schedule
4. Maintenance Logs

7) Reference, if any

1. FDA Guidance on Equipment Calibration and Maintenance
2. ISO 17025:2017 General Requirements for the Competence of Testing and Calibration Laboratories

8) SOP Version

Version 1.0