with GMP and regulatory requirements.

2. Scope

This SOP is applicable to all calibrated instruments and devices used in the Quality Control department for the analysis of raw materials, in-process materials, and finished sterile injectable products. This includes but is not limited to balances, pH meters, UV-Vis spectrophotometers, HPLC systems, FTIR, and temperature/humidity devices.

3. Responsibilities

• QC Analyst: Ensure instruments are used only if calibrated and report any calibration due or deviation.
• QC Supervisor: Verify calibration schedules, assign calibration responsibilities, and review calibration data.
• Engineering/Metrology Team: Perform calibration activities as per the schedule and SOP.
• QA Department: Review calibration records and ensure compliance before use of equipment for testing.

4. Accountability

The Head of Quality Control is accountable for ensuring that all QC instruments are calibrated and records maintained according to the defined procedures and regulatory standards.

5. Procedure

5.1 Calibration Planning

1. Prepare an annual calibration plan listing all QC instruments with their due calibration dates.
2. Assign unique equipment IDs and maintain a Master Calibration Schedule (Annexure-1).
3. Display a calibration status label on each instrument, indicating last calibration date, next due date, and status (Calibrated/Under Maintenance/Not Calibrated).

5.2 Calibration Execution

1. Calibrate instruments either internally by trained personnel or through external agencies approved by QA.
2. Use certified reference standards or traceable calibration instruments for each parameter.
3. Record all calibration data in the respective Calibration Log Sheet (Annexure-2).
4. Ensure instrument is clean and in idle condition before starting calibration.
5. Verify the calibration across the operating range (low, mid, high values) where applicable.

5.3 Calibration of Specific Equipment

5.3.1 Analytical Balances

• Use certified standard weights (Class E2 or equivalent).
• Calibrate at 20%, 50%, and 100% of the full capacity.
• Acceptable tolerance: ±0.1% of nominal weight.

5.3.2 pH Meters

• Use certified buffer solutions (pH 4.00, 7.00, 9.20).
• Calibrate daily before use and monthly for accuracy check.

5.3.3 UV-Visible Spectrophotometers

• Use Holmium oxide or Potassium dichromate standards.
• Check absorbance accuracy and wavelength accuracy monthly.

5.3.4 HPLC Systems

• Check flow rate, injector precision, detector linearity, and wavelength accuracy.
• Perform system suitability tests with standard solutions.

5.3.5 Temperature/Humidity Sensors

• Calibrate sensors using standard traceable reference meters.
• Perform calibration semi-annually or as per equipment criticality.

5.4 Out-of-Tolerance and Deviation Handling

1. If an instrument fails calibration, label it as “Not Calibrated” and do not use until repaired and recalibrated.
2. Initiate deviation as per SOP for Deviation Management and inform QA.
3. Investigate any impact on testing performed since last successful calibration.

5.5 Recalibration and Corrective Action

1. Recalibrate after servicing, repairs, or if instrument is moved.
2. Ensure all calibration parameters are rechecked after service intervention.
3. Update the calibration schedule and sticker after recalibration.

5.6 Documentation and Review

1. Maintain calibration certificates, logbooks, and any third-party calibration documents in calibration file.
2. QA shall verify completeness and correctness of calibration records quarterly.
3. Use the Calibration Record Review Checklist (Annexure-3) for routine QA checks.

6. Abbreviations

• SOP: Standard Operating Procedure
• QC: Quality Control
• QA: Quality Assurance
• HPLC: High-Performance Liquid Chromatography
• UV: Ultraviolet

7. Documents

1. Master Calibration Schedule – Annexure-1
2. Calibration Log Sheet – Annexure-2
3. Calibration Record Review Checklist – Annexure-3

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• ICH Q10 – Pharmaceutical Quality System
• USP General Chapter <1058> – Analytical Instrument Qualification

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	QC Analyst	QA Executive	Head QA
Department	Quality Control	Quality Assurance	Quality Assurance

11. Annexures

Annexure-1: Master Calibration Schedule

Instrument ID	Instrument Name	Last Calibration	Next Due	Status
QC-BAL-001	Analytical Balance	01/06/2025	01/12/2025	Calibrated
QC-PH-002	pH Meter	10/06/2025	10/07/2025	Calibrated

Annexure-2: Calibration Log Sheet

Date	Instrument	Standard Used	Reading	Deviation	Performed By
10/06/2025	pH Meter	Buffer 7.00	6.98	-0.02	Sunita Reddy

Annexure-3: Calibration Record Review Checklist

Record ID	Reviewed By	Date	Compliant (Yes/No)	Remarks
CAL/PH/025	Ajay Verma	12/06/2025	Yes	Within tolerance

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/05/2022	1.0	Initial Issue	New SOP	Head QA
24/06/2025	2.0	Expanded calibration sections and included annexures	Annual Review	Head QA