Standard Operating Procedure for Scheduling and Performing Instrument Calibration

1) Purpose

The purpose of this SOP is to establish a systematic procedure for scheduling and performing the calibration of instruments used in the production of ocular dosage forms to ensure accuracy, reliability, and compliance with regulatory standards.

2) Scope

This SOP applies to all instruments used in the production and quality control of ocular dosage forms within the pharmaceutical manufacturing facility, including eye drops, ointments, gels, and inserts.

3) Responsibilities

The responsibilities include developing and maintaining the calibration schedule, performing calibration activities, documenting calibration results, and ensuring that instruments are calibrated within specified intervals. Calibration personnel are responsible for executing calibration tasks, and quality assurance personnel are responsible for reviewing and approving calibration records.

4) Procedure

4.1 Development of Calibration Schedule

1. Identify all instruments that require calibration based on the manufacturer’s recommendations and regulatory requirements.
2. Develop a calibration schedule that includes the calibration frequency for each instrument.
3. Ensure that the calibration schedule is reviewed and approved by the quality assurance department.
4. Update the calibration schedule as necessary to reflect any changes in regulatory requirements or instrument usage.

4.2 Preparation for Calibration

1. Ensure that all calibration personnel are trained in the proper calibration procedures for each instrument.
2. Gather all necessary calibration standards, tools, and documentation required for the calibration activities.
3. Verify that the calibration standards are traceable to national or international standards.
4. Ensure that the instruments are clean and free from any contaminants before starting calibration activities.

4.3 Calibration Activities

1. Instrument Calibration:
   1. Perform the calibration according to the manufacturer’s instructions and relevant calibration procedures.
   2. Compare the instrument readings with the calibration standards and adjust the instrument settings as necessary.
   3. Record the calibration results, including any adjustments made, in the calibration logbook.
   4. Document any deviations or issues encountered during the calibration process.
2. Verification of Calibration:
   1. Verify the accuracy of the instrument by performing a series of test measurements.
   2. Compare the test measurements with the expected values to ensure the instrument is within the specified tolerance limits.
   3. Record the verification results in the calibration logbook.

4.4 Documentation

1. Record all calibration activities, including the date, time, and details of the tasks performed, in the calibration logbook.
2. Ensure that the logbook entries are signed and dated by the calibration personnel who performed the tasks.
3. Submit the completed calibration logbook to the quality assurance department for review and approval.

4.5 Review and Approval

1. The quality assurance personnel should review the calibration logbook for completeness, accuracy, and compliance with SOPs and regulatory requirements.
2. Any discrepancies or deviations should be investigated, documented, and resolved before approving the logbook entries.
3. Once the logbook entries are approved, they should be signed and dated by the quality assurance personnel.

4.6 Maintenance of Calibration Records

1. Store the approved calibration logbooks in a secure location to prevent loss or damage.
2. Maintain calibration records for a period specified by regulatory requirements or company policy.
3. Ensure that calibration records are easily accessible for audits and inspections.

5) Abbreviations, if any

N/A

6) Documents, if any

1. Calibration schedule
2. Calibration logbook
3. Calibration standards certificates

7) Reference, if any

GMP Guidelines for Instrument Calibration in Pharmaceutical Manufacturing

8) SOP Version

Version 1.0