Standard Operating Procedure for Calibration of Equipment Used for Creams
1) Purpose
The purpose of this SOP is to outline the procedures for the calibration of equipment used in the manufacturing of creams in a pharmaceutical facility to ensure accuracy and reliability of measurements.
2) Scope
This SOP applies to all personnel involved in the calibration of equipment used for creams within the pharmaceutical production facility. It covers procedures for scheduling calibration, performing calibration activities, and documentation.
3) Responsibilities
It is the responsibility of the maintenance and quality control (QC) teams to follow this SOP accurately. The maintenance supervisor is responsible for scheduling and performing equipment calibration, while the QC team ensures that calibrated equipment meets regulatory requirements.
4) Procedure
4.1 Calibration Schedule
4.1.1 Establish a calibration schedule for all critical equipment used in cream manufacturing based on manufacturer recommendations, regulatory requirements, and internal procedures.
4.1.2 Prioritize equipment based on criticality to product quality and regulatory compliance.
4.1.3 Notify relevant departments about upcoming calibration activities to minimize impact on production schedules.
4.2 Calibration Execution
4.2.1 Retrieve equipment calibration procedures and instructions from the manufacturer’s manuals or calibration standards.
4.2.2 Prepare calibration tools, reference standards, and calibration records as per the equipment calibration plan.
4.2.3 Perform calibration activities in a controlled environment to ensure accuracy and reliability of measurements.
4.3 Calibration Documentation
4.3.1 Record calibration data including calibration date, technician name, equipment identification, reference standards used, and calibration results.
4.3.2 Attach calibration certificates and reports to the equipment calibration logbook or electronic database.
4.3.3 Review and approve calibration records by authorized personnel to verify compliance with calibration specifications.
4.4 Out-of-Tolerance Conditions
4.4.1 Identify and document any out-of-tolerance conditions observed during equipment calibration.
4.4.2 Initiate deviation reporting and investigation to determine root cause and corrective actions required.
4.4.3 Obtain approval for equipment use from quality assurance (QA) or QC before addressing out-of-tolerance conditions.
4.5 Calibration Interval Review
4.5.1 Review calibration intervals periodically based on historical data, equipment performance, and regulatory requirements.
4.5.2 Update calibration schedules and procedures as necessary to maintain compliance with current regulations and industry standards.
4.5.3 Document calibration interval reviews and any revisions made to calibration procedures.
5) Abbreviations, if any
QC: Quality Control
QA: Quality Assurance
6) Documents, if any
Equipment Calibration Logbook
Calibration Certificates and Reports
7) Reference, if any
ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
ISO (International Organization for Standardization) 9001:2015: Quality management systems – Requirements
8) SOP Version
Version 1.0