Equipment Calibration Procedures for MDIs

1) Purpose

The purpose of this SOP is to establish the procedures for the calibration of equipment used in the manufacturing and testing of metered-dose inhalers (MDIs) to ensure accuracy, reliability, and compliance with regulatory requirements.

2) Scope

This SOP applies to all personnel involved in the calibration of equipment used for MDIs at the manufacturing facility, including calibration technicians, laboratory personnel, and quality assurance staff.

3) Responsibilities

The responsibilities for this SOP include performing equipment calibration, maintaining calibration records, and ensuring equipment accuracy. Specific roles include:
Calibration Technicians: Perform equipment calibration as per the schedule.
Laboratory Personnel: Use calibrated equipment for testing and analysis.
Quality Assurance: Verify calibration procedures and document compliance.

4) Procedure

4.1 Calibration Schedule
4.1.1 Establish a calibration schedule based on equipment criticality and regulatory requirements.
4.1.2 Ensure all calibrated equipment is labeled with calibration due dates.
4.2 Calibration Process
4.2.1 Retrieve equipment for calibration according to the schedule.
4.2.2 Verify calibration standards and reference materials.
4.2.3 Perform calibration using validated procedures and calibration protocols.
4.2.4 Record calibration results including adjustments made, if any.
4.3 Documentation
4.3.1 Maintain calibration records in the calibration logbook.
4.3.2 Include equipment identification, calibration dates, due dates, and technician signatures.
4.4 Verification of Calibration
4.4.1 Verify equipment functionality and accuracy post-calibration.
4.4.2 Perform verification checks to ensure calibrated equipment meets specifications.
4.5 Out-of-Tolerance Conditions
4.5.1 Identify and address any out-of-tolerance conditions promptly.
4.5.2 Document corrective actions taken and re-calibrate equipment if necessary.

5) Abbreviations, if any

MDI: Metered-Dose Inhaler

6) Documents, if any

Calibration certificates, calibration procedures, and calibration history records should be maintained.

7) Reference, if any

Refer to regulatory guidelines from agencies such as the FDA, EMA, and ISO 17025 for calibration standards and requirements.

8) SOP Version

Version 1.0