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 Calibration Certificates:
4.5.1 Generate calibration certificates for each calibrated equipment.
4.5.2 Archive calibration certificates for regulatory inspections and audits.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QA: Quality Assurance
6) Documents, if any
Calibration Records
Calibration Certificates
Equipment Manuals
7) Reference, if any
ISO 9001: Quality Management Systems – Requirements
FDA Guidance for Industry: Process Validation: General Principles and Practices
8) SOP Version
Version 1.0
