Standard Operating Procedure for Calibration of Laboratory Equipment

1) Purpose

The purpose of this SOP is to establish guidelines for the calibration of laboratory equipment to ensure accuracy, reliability, and compliance with regulatory requirements in pharmaceutical manufacturing facilities.

2) Scope

This SOP applies to all laboratory equipment used within pharmaceutical manufacturing facilities, including analytical instruments, balances, pH meters, and temperature controllers.

3) Responsibilities

The Quality Control (QC) Department is responsible for implementing and adhering to this SOP. The Laboratory Manager oversees the calibration of laboratory equipment.

4) Procedure

1. Calibration Schedule
   1. Develop a calibration schedule based on equipment criticality, usage frequency, and manufacturer recommendations.
   2. Assign calibration frequencies and due dates for each piece of laboratory equipment.
2. Calibration Process
   1. Prepare calibration standards and reference materials according to documented procedures.
   2. Perform calibration procedures as per manufacturer instructions or validated methods.
3. Documentation and Records
   1. Document calibration activities, including calibration dates, standards used, and calibration results.
   2. Maintain calibration certificates and traceability of measurement standards.
4. Out-of-Tolerance Conditions
   1. Identify and document out-of-tolerance conditions during calibration.
   2. Implement procedures for investigating root causes and taking corrective actions.
5. Training and Competency
   1. Provide training to laboratory personnel on calibration procedures, equipment use, and quality requirements.
   2. Ensure personnel competency through assessments and periodic training updates.

5) Abbreviations, if any

QC: Quality Control

6) Documents, if any

Calibration Schedules, Calibration Certificates, Out-of-Tolerance Reports, Training Records

7) Reference, if any

ISO 17025 standards for calibration of laboratory equipment, and relevant regulatory requirements for pharmaceutical manufacturing facilities.

8) SOP Version

Version 1.0