Standard Operating Procedure for Calibration of Analytical Instruments
1) Purpose
The purpose of this Standard Operating Procedure (SOP) is to establish a procedure for the calibration of analytical instruments used in pharmaceutical manufacturing to ensure accurate and reliable analytical results.
2) Scope
This SOP applies to all personnel involved in the calibration of analytical instruments within the pharmaceutical manufacturing facility. It covers procedures for calibration standards, methods, documentation, and calibration intervals.
3) Responsibilities
– Quality Assurance (QA) Department: Ensures compliance with SOP and regulatory guidelines.
– Quality Control (QC) Department: Performs instrument calibration and maintains calibration records.
– Engineering Department: Responsible for maintaining and servicing analytical instruments.
4) Procedure
4.1 Calibration Standards
4.1.1 Establish and maintain a library of certified calibration standards traceable to national or international standards.
4.1.2 Verify the suitability and expiration dates of calibration standards before use.
4.2 Calibration Methods
4.2.1 Follow manufacturer’s instructions and validated procedures for instrument calibration.
4.2.2 Perform calibration using appropriate calibration methods (e.g., single-point, multi-point) based on instrument type and usage.
4.3 Calibration Intervals
4.3.1 Determine calibration intervals based on instrument stability, criticality, and regulatory requirements.
4.3.2 Document calibration intervals and schedule regular calibrations to ensure instrument performance.
4.4 Calibration Execution
4.4.1 Conduct calibration in controlled environmental conditions to minimize variability.
4.4.2 Record calibration data including date, time, standard used, and calibration results.
4.5 Calibration Records
4.5.1 Maintain accurate and up-to-date calibration records for all instruments.
4.5.2 Include calibration certificates, calibration reports, and any adjustments made during calibration.
4.6 Out-of-Tolerance Conditions
4.6.1 Define criteria for out-of-tolerance conditions and actions to be taken when deviations occur.
4.6.2 Investigate root causes of out-of-tolerance results and implement corrective actions promptly.
4.7 Documentation
4.7.1 Document all calibration activities, including procedures, records, and calibration certificates.
4.7.2 Ensure that all records are reviewed and approved by the QA department.
4.8 Reporting
4.8.1 Prepare calibration reports summarizing calibration activities, results, and any corrective actions taken.
4.8.2 Submit reports to the QA department for review and archiving.
5) Abbreviations, if any
– QA: Quality Assurance
– QC: Quality Control
– SOP: Standard Operating Procedure
6) Documents, if any
– Calibration Standards Library
– Calibration Records
– Calibration Certificates
7) Reference, if any
– USP General Chapter <1058> Analytical Instrument Qualification
– ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories
8) SOP Version
Version 1.0
