instruments used for testing raw materials, in-process gels, and finished gel products in the Quality Control Laboratory associated with Gel Manufacturing.

3. Responsibilities

• QC Analyst: Performs calibration as per schedule and documents calibration results.
• QA Officer: Verifies calibration compliance and reviews documentation.
• QC Head: Approves calibration schedules and signs off calibration certificates.
• Engineering Department: Provides maintenance support and external calibration coordination.

4. Accountability

The Head – Quality Control is accountable for ensuring all instruments are calibrated according to the defined frequency and that the instruments are fit for intended use in gel product testing.

5. Procedure

5.1 Instrument Identification and Listing

1. Maintain a comprehensive list of all QC instruments in the “Instrument Master List” (Annexure-1).
2. Assign a unique instrument code to each device for traceability.

5.2 Calibration Planning

1. Prepare an annual calibration schedule based on manufacturer’s recommendation, instrument usage, and criticality.
2. Update the “Calibration Schedule Log” (Annexure-2) at the beginning of every calendar year.

5.3 Internal Calibration

1. Perform internal calibration for instruments like:
   • pH meters (using certified buffer solutions)
   • Balances (using standard weights)
   • Viscometers (using standard viscosity liquids)
2. Record all results in the “Internal Calibration Record Sheet” (Annexure-3).
3. Ensure results fall within predefined acceptance criteria. If not, escalate to QA.

5.4 External Calibration

1. Coordinate with approved third-party vendors for calibration of instruments like:
   • UV-Vis Spectrophotometer
   • FTIR
   • GC/HPLC (if applicable)
2. Maintain calibration certificates in an indexed folder with cross-reference to Instrument ID.
3. Log external calibration in the “External Calibration Summary” (Annexure-4).

5.5 Calibration Status Labeling

1. Affix a “Calibration Label” to each instrument indicating:
   • Instrument ID
   • Date of Calibration
   • Next Due Date
   • Status: Calibrated / Out of Calibration

5.6 Handling Out-of-Calibration Instruments

1. If calibration fails, label the instrument as “OUT OF CALIBRATION – DO NOT USE.”
2. Initiate deviation report and investigate the impact on previous test results.
3. Send the instrument for servicing or replacement as needed.

5.7 Review and Control

1. QA reviews calibration records monthly.
2. Audit readiness ensured through monthly checks and reconciliation of calibration certificates.

6. Abbreviations

• QC: Quality Control
• QA: Quality Assurance
• UV-Vis: Ultraviolet–Visible Spectroscopy
• FTIR: Fourier-Transform Infrared Spectroscopy
• GC: Gas Chromatography
• HPLC: High-Performance Liquid Chromatography

7. Documents

1. Instrument Master List – Annexure-1
2. Calibration Schedule Log – Annexure-2
3. Internal Calibration Record Sheet – Annexure-3
4. External Calibration Summary – Annexure-4

8. References

• ICH Q9: Quality Risk Management
• 21 CFR Part 211.68 – Automatic, Mechanical, and Electronic Equipment
• USP <1058> Analytical Instrument Qualification

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Jr. Production Chemist	QA Executive	Head – Manufacturing
Department	Gel Manufacturing	Quality Assurance	Manufacturing

11. Annexures

Annexure-1: Instrument Master List

Sr. No.	Instrument Name	ID Code	Location	Calibration Frequency	Status

Annexure-2: Calibration Schedule Log

Month	Instrument ID	Instrument Name	Scheduled Date	Completion Date	Done By	Status

Annexure-3: Internal Calibration Record Sheet

Date	Instrument ID	Standard Used	Observed Value	Acceptance Range	Pass/Fail	Remarks

Annexure-4: External Calibration Summary

Calibration Date	Instrument ID	Service Provider	Certificate No.	Next Due Date	Status

Revision History

Revision Date	Revision No.	Change Description	Reason	Approved By
01/06/2022	1.0	Initial Issue	New SOP	QA Head
02/06/2025	2.0	Inclusion of external calibration log and annexure updates	Periodic Review	QA Head