Standard Operating Procedure for Calibration of Equipment Used for Transdermal Patches

1) Purpose

The purpose of this SOP is to establish procedures for the calibration of equipment used in the manufacturing and testing of transdermal patches to ensure accuracy, reliability, and compliance with regulatory requirements.

2) Scope

This SOP applies to all equipment used in the production, testing, and packaging of transdermal patches that require calibration to maintain process control and product quality.

3) Responsibilities

The Quality Control (QC) Department is responsible for implementing and overseeing the calibration activities as outlined in this SOP. The Engineering Department assists in performing calibrations and maintaining calibration records.

4) Procedure

4.1 Calibration Schedule

• 4.1.1 Establish a calibration schedule based on equipment criticality and usage frequency.
• 4.1.2 Schedule initial calibration upon installation and periodic recalibrations as per manufacturer recommendations or regulatory requirements.

4.2 Calibration Process

• 4.2.1 Identify the equipment requiring calibration and ensure it is not in use during the calibration process.
• 4.2.2 Use calibrated standards traceable to national or international standards for performing calibrations.
• 4.2.3 Follow manufacturer-provided procedures or standard operating procedures for each equipment type.
• 4.2.4 Record pre-calibration and post-calibration readings and adjustments.

4.3 Documentation

• 4.3.1 Maintain a calibration logbook for each piece of equipment, recording calibration dates, results, adjustments made, and personnel performing the calibration.
• 4.3.2 Retain calibration certificates and records of traceability to national or international standards.
• 4.3.3 Archive outdated calibration records as per the facility’s document retention policy.

4.4 Out-of-Tolerance Conditions

• 4.4.1 Define criteria for determining when equipment is out of tolerance.
• 4.4.2 Implement procedures for addressing out-of-tolerance conditions, including immediate corrective actions, re-calibration, and impact assessment on product quality.

4.5 Preventive Maintenance

• 4.5.1 Integrate calibration activities with preventive maintenance schedules to ensure equipment reliability.
• 4.5.2 Perform routine checks and inspections to identify potential calibration issues before they affect product quality.

5) Abbreviations, if any

QC: Quality Control

6) Documents, if any

Calibration Logbook
Calibration Certificates

7) Reference, if any

ISO 9001: Quality management systems – Requirements
US FDA 21 CFR Part 211: Current Good Manufacturing Practice for Finished Pharmaceuticals

8) SOP Version

Version 1.0