Standard Operating Procedure for Calibration of Spectrophotometers

1) Purpose

The purpose of this SOP is to establish the procedures for calibrating spectrophotometers to ensure accuracy and reliability in optical measurements as per regulatory requirements in the pharmaceutical industry.

2) Scope

This SOP applies to all spectrophotometers used in the pharmaceutical manufacturing process.

3) Responsibilities

The Quality Assurance Department is responsible for implementing and adhering to this SOP. All personnel involved in the calibration process must be trained and qualified.

4) Procedure

1. Calibration Schedule Establishment
   1. Develop a calibration schedule based on spectrophotometer criticality, manufacturer recommendations, and regulatory requirements.
   2. Assign unique identification numbers or labels to each spectrophotometer for traceability.
   3. Document calibration frequency and tolerance limits for each spectrophotometer.
2. Calibration Process
   1. Retrieve the spectrophotometer to be calibrated from its designated location.
   2. Verify the spectrophotometer’s identity and check its condition for any physical damage.
   3. Prepare calibration standards of known optical properties.
   4. Calibrate the spectrophotometer using certified calibration standards and procedures.
   5. Record calibration results including before and after values, adjustments made, and calibration date.
   6. Apply calibration labels indicating next due date and calibration status.
3. Out-of-Tolerance Conditions
   1. If a spectrophotometer is found out-of-tolerance, quarantine it immediately and perform investigation to determine impact.
   2. Take corrective action, recalibrate if possible, or arrange for repair by authorized personnel.
   3. Document all actions taken, including investigation findings and corrective measures.
4. Record Keeping
   1. Maintain accurate records of all calibration activities, including calibration certificates, calibration history, and maintenance logs.
   2. Archive records for easy retrieval during audits or inspections.

5) Abbreviations, if any

None

6) Documents, if any

Calibration Certificates, Calibration Logs, Maintenance Records

7) Reference, if any

Relevant regulatory guidelines such as FDA, EMA, and WHO GMP requirements for calibration of spectrophotometers.

8) SOP Version

Version 1.0