machines, balances, and pipettes.

3. Responsibilities

• Calibration Coordinator: Maintains calibration schedules, performs verification, and records results.
• Department Heads: Ensure no uncalibrated equipment is used during study conduct.
• QA Officer: Reviews calibration logs during audits and ensures compliance with SOP.
• Clinical/Bioanalytical Personnel: Use only calibrated and qualified instruments.

4. Accountability

The Head of Facility/Operations is accountable for ensuring that all critical equipment used in BA/BE studies is regularly calibrated and documented, and that no uncalibrated equipment is used during trial procedures.

5. Procedure

5.1 Identification of Equipment Requiring Calibration

1. Maintain a master list of equipment requiring periodic calibration using Annexure-1: Equipment Master Calibration List.
2. Equipment must be categorized based on usage:
   • Critical (e.g., balances, pipettes, temperature devices)
   • Supportive (e.g., water baths, centrifuges)

5.2 Calibration Schedule and Planning

1. Create a calibration schedule for each equipment item based on manufacturer recommendations and regulatory requirements.
2. Use Annexure-2: Equipment Calibration Planner to track due dates.
3. Calibrations must be performed:
   • Prior to study initiation
   • Annually or as per validation report
   • After repair or relocation

5.3 Calibration Procedure and Documentation

1. Use certified external agencies or trained internal personnel for calibration.
2. Document each calibration in Annexure-3: Equipment Calibration Log including:
   • Date of calibration
   • Next due date
   • Calibration result
   • Deviation (if any)
   • Calibration certificate reference
3. Affix calibration status label on equipment with:
   • Calibration date
   • Due date
   • Technician initials

5.4 Handling of Calibration Failures

1. Immediately tag equipment as “OUT OF SERVICE”.
2. Do not use equipment until recalibrated and qualified.
3. Document action taken in Annexure-4: Calibration Deviation Report.

5.5 Record Retention and Audit Preparedness

1. Retain all calibration records and certificates for at least 5 years or per sponsor requirements.
2. Ensure availability of logs for regulatory audits and inspections.
3. QA must perform quarterly review of calibration compliance using Annexure-5: Calibration Audit Checklist.

6. Abbreviations

• BA: Bioavailability
• BE: Bioequivalence
• QA: Quality Assurance
• SOP: Standard Operating Procedure

7. Documents

1. Equipment Master Calibration List – Annexure-1
2. Equipment Calibration Planner – Annexure-2
3. Equipment Calibration Log – Annexure-3
4. Calibration Deviation Report – Annexure-4
5. Calibration Audit Checklist – Annexure-5

8. References

• ICH E6(R2) – Good Clinical Practice
• WHO TRS 937 Annex 4 – Equipment Qualification
• 21 CFR Part 58 – Good Laboratory Practice

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Equipment Master Calibration List

Equipment ID	Name	Location	Frequency	Calibration Agency
EQ-01	Precision Balance	Bio Lab	Annually	ABC Calibrations

Annexure-2: Equipment Calibration Planner

Equipment ID	Due Date	Planned Date	Status	Remarks
EQ-01	30/04/2025	25/04/2025	Scheduled	Ready

Annexure-3: Equipment Calibration Log

Date	Equipment ID	Result	Next Due	Calibrated By
25/04/2024	EQ-01	Pass	25/04/2025	Ajay Verma

Annexure-4: Calibration Deviation Report

Date	Equipment ID	Issue	Action Taken	Closed By
15/03/2025	EQ-02	Drift in readings	Recalibrated	QA Manager

Annexure-5: Calibration Audit Checklist

Date	Auditor	Equipment Reviewed	Findings	Action Required
01/04/2025	Sunita Reddy	Freezers, Balances	Compliant	None

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
15/01/2022	1.0	Initial release	Regulatory requirement	QA Head
17/04/2025	2.0	Updated with deviation reporting and audit checklist	Internal QA Review	QA Head