Standard Operating Procedure (SOP) for Validation and Calibration

Objective: To establish procedures for the validation and calibration of equipment and processes to
ensure accuracy, reliability, and compliance with regulatory requirements.

Scope

This SOP applies to all validation and calibration activities conducted within the organization.

Responsibilities

Specify the roles and responsibilities of personnel involved in validation and calibration.

Validation

Describe the process for validating equipment, processes, and systems.

Include acceptance criteria and documentation requirements.

Calibration

Refer to the SOP for Handling Equipment and Instruments for guidelines on calibration procedures.

Documentation

Explain how validation and calibration data, reports, and records should be documented, reviewed,
and retained.

Training

Include requirements for training personnel involved in validation and calibration activities.