Standard Operating Procedure for Calibration of Measuring Instruments
1) Purpose
The purpose of this SOP is to establish procedures for the calibration of measuring instruments used in the manufacturing of dental dosage forms, ensuring that all instruments provide accurate and reliable measurements necessary for maintaining product quality and regulatory compliance.
2) Scope
This SOP applies to all measuring instruments used in the production, testing, and control of dental pastes, gels, and mouthwashes within the pharmaceutical industry, including but not limited to scales, thermometers, pH meters, and pressure gauges.
3) Responsibilities
The Quality Assurance (QA) Department is responsible for overseeing the calibration program. The Engineering Department is responsible for performing calibrations and maintaining calibration records. All personnel using measuring instruments are responsible for ensuring instruments are within their calibration period before use.
4) Procedure
4.1 Identification of Instruments for Calibration
4.1.1 Compile a list of all measuring instruments requiring calibration, including details such as instrument type, manufacturer, model, serial number, and location.
4.1.2 Assign a unique identification number to each instrument for tracking purposes.
4.2 Calibration Schedule
4.2.1 Develop a calibration schedule based on the criticality of measurements, manufacturer’s recommendations, regulatory requirements, and historical calibration data.
4.2.2 Ensure that all instruments are calibrated at appropriate intervals and maintain an up-to-date calibration schedule.
4.3 Calibration Procedures
4.3.1 Follow manufacturer’s instructions and approved calibration procedures for each type of instrument, using certified reference standards and equipment.
4.3.2 Document calibration results, including the date of calibration, reference standards used, calibration readings, and any adjustments made.
4.3.3 Affix calibration status labels to instruments, indicating the date of calibration and the due date for the next calibration.
4.4 Handling Out-of-Tolerance Instruments
4.4.1 Identify any instruments found to be out of tolerance during calibration and remove them from service immediately.
4.4.2 Investigate and document the impact of using out-of-tolerance instruments on product quality and take appropriate corrective actions.
4.4.3 Recalibrate or replace out-of-tolerance instruments before returning them to service.
4.5 Record-Keeping and Documentation
4.5.1 Maintain comprehensive calibration records for each instrument, including calibration certificates, calibration logs, and records of any adjustments or repairs.
4.5.2 Store calibration records in a manner that ensures easy retrieval for audits and inspections.
5) Abbreviations, if any
SOP – Standard Operating Procedure
QA – Quality Assurance
6) Documents, if any
Instrument Calibration Schedule
Calibration Procedures and Instructions
Calibration Certificates
Calibration Logs
7) Reference, if any
Manufacturer’s instructions for calibration
Regulatory guidelines for calibration of measuring instruments
8) SOP Version
Version 1.0
