The QC Manager is accountable for ensuring that routine inspections of QC laboratory equipment are performed according to this SOP. The Maintenance Supervisor is responsible for ensuring that all necessary repairs and calibrations are completed on time. The QA Manager is responsible for reviewing and approving the inspection records.

5. Procedure

5.1 Pre-Inspection Preparation

1. Ensure that all QC laboratory equipment is clean and in proper working order before beginning the inspection. Any equipment found to be malfunctioning or requiring calibration should be tagged for repair or calibration.
2. Review the equipment manuals and calibration certificates to confirm the manufacturer’s specifications and calibration requirements for each piece of equipment.
3. Prepare an inspection checklist (Annexure-1) for each type of equipment to ensure that all critical components and functions are checked during the inspection process.
4. Assign qualified personnel to perform the inspection and ensure that they are familiar with the equipment and its operational procedures.

5.2 Routine Inspection Procedure

1. Inspect each piece of equipment according to the inspection checklist. The inspection should include, but not be limited to, the following:
   • Physical condition of the equipment (e.g., signs of wear, corrosion, or damage)
   • Calibration status (check if the equipment is calibrated within the required frequency and has up-to-date calibration certificates)
   • Operational performance (e.g., checking for accurate readings, proper functioning of all components, and response to calibration standards)
   • Cleaning and maintenance status (ensure the equipment is properly cleaned and maintained as per the manufacturer’s guidelines)
2. Record the results of the inspection on the QC Equipment Inspection Log (Annexure-1). Document any issues found during the inspection, including equipment failures, calibration discrepancies, or signs of wear that require maintenance.
3. If any equipment fails the inspection, tag it for immediate repair and notify the Maintenance Team. Follow up to ensure that repairs are completed and the equipment is re-calibrated as necessary.

5.3 Calibration and Maintenance

1. If equipment calibration is found to be outside of specification, arrange for the calibration to be performed by a qualified technician. Document the calibration results in the Calibration Log (Annexure-2).
2. If the inspection reveals a need for maintenance, such as cleaning or replacing worn parts, schedule the maintenance to be performed as soon as possible to prevent equipment downtime.
3. Ensure that all maintenance and calibration records are properly documented and kept up to date in the Equipment Maintenance Log (Annexure-3).

5.4 Post-Inspection Activities

1. Once the inspection and any necessary repairs or calibrations are completed, update the equipment status to “Operational” and remove any tags indicating that the equipment was out of service.
2. Review the inspection records, calibration logs, and maintenance reports for completeness and accuracy. Ensure that all corrective actions have been documented and properly implemented.
3. Submit the inspection records and maintenance logs for review and approval by the QA team to ensure compliance with GMP standards.

5.5 Documentation and Record-Keeping

1. Ensure that all inspection records, calibration logs, and maintenance reports are complete, accurate, and securely stored. This includes the QC Equipment Inspection Log (Annexure-1), Calibration Log (Annexure-2), and Equipment Maintenance Log (Annexure-3).
2. Retain all records for a minimum of two years or as required by regulatory guidelines.
3. Ensure that records are reviewed and approved by the Quality Assurance team to verify compliance with GMP standards and regulatory requirements.

6. Abbreviations

• GMP: Good Manufacturing Practices
• QC: Quality Control
• QA: Quality Assurance
• PPE: Personal Protective Equipment

7. Documents

1. Annexure-1: QC Equipment Inspection Log
2. Annexure-2: Calibration Log
3. Annexure-3: Equipment Maintenance Log

8. References

• Good Manufacturing Practices (GMP) Guidelines – 21 CFR Part 211
• International Conference on Harmonisation (ICH) Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• Manufacturer’s Equipment Manuals

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: QC Equipment Inspection Log

Equipment Name	Inspection Date	Condition	Calibration Status	Action Taken	Operator
Viscometer	21/01/2026	Operational	Calibrated	None	John Doe

Annexure-2: Calibration Log

Equipment Name	Calibration Date	Calibrated By	Calibration Status
Viscometer	21/01/2026	Jane Smith	Passed

Annexure-3: Equipment Maintenance Log

Equipment Name	Maintenance Date	Maintenance Description	Technician	Action Taken
Viscometer	20/01/2026	Replaced worn seals	John Smith	Seal replacement completed

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/03/2024	1.0	Initial Version	New SOP Creation	QA Head
01/03/2025	2.0	Format Revision and Updates	Standardization of Document	QA Head