Standard Operating Procedure for Calibration and Maintenance of Equipment

1) Purpose

The purpose of this SOP is to establish procedures for the calibration, maintenance, and verification of equipment to ensure accuracy, reliability, and compliance with regulatory requirements.

2) Scope

This SOP applies to all equipment within the manufacturing facility that is used for production, testing, and control of pharmaceutical products.

3) Responsibilities

The responsibilities for this SOP are divided among various roles:

3.1 Maintenance Technician:

Responsible for performing routine maintenance and calibration of equipment as per established procedures.

3.2 Quality Assurance (QA) Personnel:

Responsible for overseeing the calibration and maintenance program, including review of calibration records and schedules.

3.3 Production Supervisor:

Responsible for ensuring equipment is available and operational for production activities.

4) Procedure

4.1 Equipment Identification:

4.1.1 Maintain a list of all equipment requiring calibration and maintenance.
4.1.2 Assign unique equipment identification numbers for tracking purposes.
4.1.3 Update equipment inventory regularly.

4.2 Calibration Schedule:

4.2.1 Develop a calibration schedule based on equipment criticality and regulatory requirements.
4.2.2 Determine calibration intervals and frequencies for each piece of equipment.
4.2.3 Obtain approval for the calibration schedule from QA.

4.3 Calibration Procedure:

4.3.1 Perform pre-calibration checks and preparations.
4.3.2 Calibrate equipment using calibrated standards and procedures.
4.3.3 Record calibration results, including adjustments made.

4.4 Maintenance and Verification:

4.4.1 Conduct routine maintenance activities as per equipment manufacturer’s recommendations.
4.4.2 Verify equipment performance through functional checks and performance testing.
4.4.3 Document maintenance and verification activities in the Equipment Logbook.

4.5 Calibration Records:

4.5.1 Maintain accurate and up-to-date calibration records for each piece of equipment.
4.5.2 Archive calibration records according to established document retention policies.
4.5.3 Provide calibration records during internal and regulatory audits as required.

5) Abbreviations, if any

QA – Quality Assurance

6) Documents, if any

1. Equipment Inventory List
2. Calibration Schedule
3. Calibration Records
4. Equipment Logbook

7) Reference, if any

1. FDA Guidance on Equipment Calibration
2. ISO 9001 Quality management systems — Requirements

8) SOP Version

Version 1.0