Protocol for Calibration and Maintenance of Laboratory Instruments
Purpose
The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the calibration, verification, and maintenance of analytical equipment used in Bioavailability (BA) and Bioequivalence (BE) studies conducted in the pharmaceutical industry.
Scope
This SOP applies to all personnel involved in the operation, calibration, and maintenance of laboratory instruments, including Analytical Chemists, Laboratory Managers, and Maintenance Technicians.
Responsibilities
- The Laboratory Manager is responsible for overseeing the calibration and maintenance program, ensuring compliance with SOPs and regulatory requirements.
- The Analytical Chemist or designated personnel are responsible for performing routine calibration, verification, and maintenance activities according to established schedules and procedures.
- The Maintenance Technician is responsible for troubleshooting equipment issues, performing repairs, and coordinating external service as needed.
Procedure
- Establish a calibration and maintenance schedule for each analytical instrument based on manufacturer recommendations, regulatory requirements, and laboratory needs.
- Perform initial instrument installation and qualification, including verification of performance specifications and calibration against certified standards.
- Document all calibration and maintenance activities in a dedicated logbook or electronic database, including dates, procedures performed, and results obtained.
- Calibrate analytical instruments at regular intervals using traceable standards and procedures, ensuring accuracy, precision, and reliability of measurements.
- Verify instrument performance parameters, such as accuracy, linearity, and sensitivity, using appropriate test methods and reference materials.
- Perform routine preventive maintenance tasks, such as cleaning, lubrication, and adjustment, to ensure optimal instrument performance and longevity.
- Address any identified deviations or out-of-specification results promptly, documenting corrective actions taken and any impact on data integrity.
- Coordinate external calibration and repair services as needed, maintaining records of service contracts, vendor communications, and service reports.
Abbreviations
- SOP – Standard Operating Procedure
- BA – Bioavailability
- BE – Bioequivalence
Documents
- Calibration and Maintenance Logbook
- Instrument Qualification Records
- Service Contracts and Reports
- Deviation Reports
Reference
International Conference on Harmonisation (ICH) Q2(R1) Validation of Analytical Procedures and relevant regulatory guidance documents for equipment calibration and maintenance.
SOP Version
Version 1.0
