Procedure for Ensuring Calibration of Critical Instruments

Department	Quality Assurance (QA)/Validation/Engineering/Quality Control (QC)/Production
SOP No.	SOP/Ointment/137
Supersedes	V 1.0
Page No.	Page X of Y
Issue Date	[Insert Issue Date]
Effective Date	[Insert Effective Date]
Review Date	[Insert Review Date]

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish a systematic approach for ensuring the calibration of critical instruments used in ointment manufacturing. Proper calibration ensures measurement accuracy, consistency, and compliance with regulatory standards.

2. Scope

This SOP applies to all personnel in the Quality Assurance (QA), Validation, Engineering, Quality Control (QC), and Production departments responsible for calibration and verification of critical instruments used in production and laboratory analysis.

3. Responsibilities

• QA Officer: Ensures compliance with calibration protocols.
• Validation Team: Develops calibration procedures and standards.
• Engineering Team: Conducts instrument calibration and maintains records.
• QC Analyst: Verifies calibration results and ensures accuracy.
• Production Supervisor: Ensures calibrated instruments are used in manufacturing.
• QA Manager: Approves calibration records and ensures regulatory compliance.

4. Accountability

The QA and Validation Managers are accountable for ensuring that all critical instruments are calibrated as per GMP, FDA, ICH, and WHO guidelines.

5. Procedure

5.1 Identification of Critical Instruments

• Maintain an updated list of all critical instruments requiring calibration.
• Classify instruments based on their function:
  • Production Equipment: Mixing tank sensors, temperature controllers, pressure gauges.
  • Laboratory Instruments: Balances, pH meters, HPLC, spectrophotometers.
  • Environmental Monitoring: HVAC sensors, humidity controllers, particle counters.
• Define calibration frequency based on manufacturer recommendations and regulatory requirements.

5.2 Calibration Scheduling

• Develop an annual calibration schedule covering all critical instruments.
• Assign calibration dates and responsible personnel for each instrument.
• Ensure calibration is conducted before the due date to prevent deviations.

5.3 Calibration Procedure

• Ensure instruments are clean and in working condition before calibration.
• Use certified calibration standards and reference materials.
• Perform calibration checks according to the instrument-specific calibration SOP.
• Record pre-calibration and post-calibration measurements.
• Adjust instruments if necessary to bring them within acceptable limits.

5.4 Calibration Acceptance Criteria

• Compare calibration results against defined acceptance limits.
• If an instrument fails calibration:
  • Investigate root cause.
  • Initiate corrective actions.
  • Recalibrate the instrument after adjustments.
• Instruments failing recalibration must be removed from use until repaired or replaced.

5.5 Handling Deviations

• Record any calibration deviations and determine their impact on product quality.
• Assess whether any affected batches need to be re-evaluated.
• Implement corrective and preventive actions (CAPA) as required.

5.6 Documentation and Record Maintenance

• Maintain calibration certificates for all critical instruments.
• Ensure calibration records include:
  • Instrument ID and location
  • Calibration date and due date
  • Calibration method and standards used
  • Results before and after calibration
  • Approval signatures
• Store calibration records for regulatory audits and inspections.

6. Abbreviations

• GMP – Good Manufacturing Practices
• QA – Quality Assurance
• QC – Quality Control
• HPLC – High-Performance Liquid Chromatography
• CAPA – Corrective and Preventive Actions

7. Documents

• Calibration Record Log (Annexure-1)
• Calibration Certificate (Annexure-2)

8. References

• ICH Q7 – Good Manufacturing Practice Guide
• WHO Guidelines for Instrument Calibration
• US FDA Guidance on Equipment Calibration

9. SOP Version

Version 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Calibration Record Log

Date	Instrument ID	Location	Calibration Performed By	Result	Reviewed By
01/02/2025	PHM-1001	QC Lab	John Doe	Pass	QA Manager
02/02/2025	BAL-2002	Production	Jane Smith	Pass	QA Manager

Annexure-2: Calibration Certificate

Instrument ID	Instrument Type	Calibration Date	Next Calibration Due	Calibrated By	Approved By
PHM-1001	pH Meter	01/02/2025	01/02/2026	John Doe	QA Manager
BAL-2002	Analytical Balance	02/02/2025	02/02/2026	Jane Smith	QA Manager

12. Revision History:

Revision Date	Revision No.	Details of Revision	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP	QA Head
01/02/2025	2.0	Updated SOP Format	Standardization of Document	QA Head