Standard Operating Procedure for Calibration of Equipment
1) Purpose
The purpose of this SOP is to ensure that all manufacturing equipment used in the production of dental dosage forms is calibrated accurately to maintain product quality and compliance with regulatory requirements.
2) Scope
This SOP applies to all equipment used in the manufacturing of dental pastes, gels, and mouthwashes within the pharmaceutical industry that requires calibration.
3) Responsibilities
The Engineering Department is responsible for performing equipment calibration. The Quality Assurance (QA) Department is responsible for reviewing and approving the calibration records and ensuring compliance with the calibration schedule.
4) Procedure
4.1 Preparation
4.1.1 Develop a calibration schedule based on equipment manufacturer’s recommendations and regulatory requirements.
4.1.2 Gather all necessary calibration tools, standards, and documentation.
4.2 Calibration Process
4.2.1 Ensure the equipment is clean and in good working condition before calibration.
4.2.2 Perform calibration using certified calibration standards and tools according to the manufacturer’s instructions.
4.2.3 Record the calibration results, including any adjustments made to the equipment.
4.2.4 If the equipment does not meet the required standards, perform necessary adjustments and recalibrate until compliance is achieved.
4.3 Documentation
4.3.1 Document all calibration activities in the calibration log, including calibration results, adjustments made, and tools used.
4.3.2 Attach any calibration certificates and relevant data to the calibration log.
4.4 Approval
4.4.1 Submit the completed calibration log to the QA Department for review and approval.
4.4.2 Store the approved calibration log in the equipment calibration file.
5) Abbreviations, if any
QA – Quality Assurance
6) Documents, if any
Calibration Schedule
Calibration Log
Calibration Certificates
7) Reference, if any
Current Good Manufacturing Practices (cGMP) guidelines
8) SOP Version
Version 1.0
