Standard Operating Procedure for Calibration of Equipment Used for Aerosol Production

1) Purpose

The purpose of this SOP is to outline the procedures for the calibration of equipment used in the production of aerosols in the pharmaceutical industry. Calibration ensures the accuracy and reliability of equipment measurements, critical for maintaining product quality and compliance with regulatory standards.

2) Scope

This SOP applies to all equipment used in aerosol production processes at [Company Name], including but not limited to dispensers, fillers, and analytical instruments requiring calibration.

3) Responsibilities

Quality Assurance (QA) Manager: Oversees calibration procedures and ensures compliance.
Calibration Technicians: Perform equipment calibration as per SOP.
Production Supervisors: Coordinate equipment downtime for calibration activities.

4) Procedure

4.1 Calibration Schedule:
4.1.1 Establish a calibration schedule based on equipment criticality and regulatory requirements.
4.1.2 Record calibration due dates and schedule activities accordingly.

4.2 Calibration Protocol:
4.2.1 Retrieve equipment calibration procedures from manufacturer manuals or validated methods.
4.2.2 Ensure calibration procedures are approved and up-to-date.

4.3 Calibration Execution:
4.3.1 Perform pre-calibration checks and adjustments as necessary.
4.3.2 Conduct calibration using calibrated standards and traceable methods.

4.4 Documentation:
4.4.1 Record calibration results, including before and after calibration readings.
4.4.2 Document any adjustments made during calibration and verify equipment performance.

4.5