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