SOP for Calibration and Maintenance of Analytical Equipmen

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

1. Establish a calibration and maintenance schedule for each analytical instrument based on manufacturer recommendations, regulatory requirements, and laboratory needs.
2. Perform initial instrument installation and qualification, including verification of performance specifications and calibration against certified standards.
3. Document all calibration and maintenance activities in a dedicated logbook or electronic database, including dates, procedures performed, and results obtained.
4. Calibrate analytical instruments at regular intervals using traceable standards and procedures, ensuring accuracy, precision, and reliability of measurements.
5. Verify instrument performance parameters, such as accuracy, linearity, and sensitivity, using appropriate test