SOP for Managing Calibration Schedules for Manufacturing Instruments
| Department | Aerosol |
|---|---|
| SOP No. | SOP/Aerosol/168/2025 |
| Supersedes | SOP/Aerosol/168/2022 |
| Page No. | Page 1 of Y |
| Issue Date | 06/02/2025 |
| Effective Date | 16/02/2025 |
| Review Date | 06/02/2028 |
1. Purpose
The purpose of this Standard Operating Procedure (SOP) is to outline the process for managing calibration schedules for manufacturing instruments used in aerosol production. Regular calibration ensures that instruments provide accurate measurements, maintain product quality, and comply with Good Manufacturing Practices (GMP).
2. Scope
This SOP applies to all instruments used in aerosol manufacturing, including weighing balances, pressure gauges, temperature sensors, humidity meters, and flow meters. It covers calibration scheduling, execution, documentation, and corrective actions for out-of-tolerance conditions.
3. Responsibilities
- Engineering and Maintenance Team: Responsible for scheduling and executing calibration activities.
- Quality Assurance (QA) Team: Responsible for verifying calibration records and ensuring compliance with regulatory requirements.
- Production Team: Responsible for reporting any malfunctioning or inaccurate instruments.
- External Calibration Service Providers: Responsible for calibrating instruments that require third-party verification.
4. Accountability
The Engineering Manager is accountable for ensuring that all instruments are calibrated as per schedule and that necessary corrective actions are taken for out-of-tolerance instruments.
5. Procedure
5.1. Identifying Instruments for Calibration
- Create an inventory of all instruments requiring calibration and document them in the Calibration Master List (Annexure-1).
- Assign a unique identification number to each
instrument for tracking purposes.
Classify instruments based on criticality:
- Critical: Instruments directly affecting product quality.
- Non-Critical: Instruments used for general monitoring purposes.
5.2. Establishing Calibration Schedules
- Define calibration frequencies based on manufacturer recommendations and regulatory guidelines.
- Calibration intervals should be:
- Monthly for high-precision instruments.
- Quarterly for medium-risk instruments.
- Annually for low-risk instruments.
- Document calibration schedules in the Calibration Schedule Log (Annexure-2).
5.3. Conducting Calibration
- Calibration should be performed by trained personnel or external calibration service providers.
- Use certified calibration standards traceable to national or international measurement bodies.
- Record calibration results in the Calibration Report (Annexure-3), including:
- Pre-calibration readings.
- Post-calibration adjustments.
- Pass/fail status.
- Tag instruments with calibration status labels indicating the next due date.
5.4. Handling Out-of-Tolerance Instruments
- If an instrument fails calibration, it should be:
- Immediately removed from use.
- Reported to the QA team for impact assessment.
- Repaired or replaced before reuse.
- All out-of-tolerance incidents should be documented in the Out-of-Tolerance Log (Annexure-4).
- Implement corrective actions based on root cause analysis and record them in the CAPA Log (Annexure-5).
5.5. Maintaining Calibration Records
- All calibration records should be reviewed and approved by the QA team.
- Calibration certificates should be stored for at least five years for audit and compliance purposes.
- Ensure that records are accessible for regulatory inspections.
6. Abbreviations
- GMP: Good Manufacturing Practice
- QA: Quality Assurance
- SOP: Standard Operating Procedure
- CAPA: Corrective and Preventive Action
- ISO: International Organization for Standardization
7. Documents
- Calibration Master List (Annexure-1)
- Calibration Schedule Log (Annexure-2)
- Calibration Report (Annexure-3)
- Out-of-Tolerance Log (Annexure-4)
- CAPA Log (Annexure-5)
8. References
- Good Manufacturing Practice (GMP) Guidelines
- ISO 17025 – Calibration Standards
- FDA Calibration and Equipment Maintenance Guidelines
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 Master List
| Instrument ID | Instrument Name | Calibration Frequency | Next Due Date |
|---|---|---|---|
| INS-001 | Weighing Balance | Monthly | 06/03/2025 |
Annexure-2: Calibration Schedule Log
| Instrument ID | Calibration Date | Performed By | Pass/Fail |
|---|---|---|---|
| INS-001 | 06/02/2025 | Rajesh Patel | Pass |
12. Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | V 1.0 | Initial Release | First Issue | Anjali Sharma |
| 01/01/2025 | V 2.0 | Updated calibration procedures | GMP Compliance | Anjali Sharma |