SOP Guide for Pharma

SOP for Equipment Verification and Calibration

Auditor

Standard Operating Procedure for Equipment Verification and Calibration

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for the verification and calibration of equipment used in the pharmaceutical manufacturing process. This SOP ensures that all equipment is regularly checked for accuracy, precision, and compliance with required specifications to maintain the quality and integrity of the products.

2. Scope

This SOP applies to all equipment used in the manufacturing process, including but not limited to, weighing scales, temperature controllers, pressure gauges, and pH meters.

3. Responsibilities

  • Equipment Operators: Responsible for performing daily visual checks of the equipment and reporting any abnormalities to the maintenance team.
  • Maintenance Team: Responsible for conducting regular verification and calibration of equipment as per the defined schedule.
  • Quality Assurance (QA) Department: Responsible for overseeing the verification and calibration processes, ensuring compliance with this SOP.
  • Production Manager: Responsible for ensuring that equipment verification and calibration are performed timely and as per schedule.
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4. Procedure

4.1 Daily Visual Checks:

  • Operators should visually inspect the equipment before use to ensure that there are no visible damages, leaks, or abnormal readings.
  • Report any abnormalities or malfunctions to the maintenance team immediately.
  • Keep a log of daily visual checks and maintenance reports for future reference.

4.2 Verification of Equipment:

  • Establish a schedule for
regular equipment verification based on manufacturer recommendations and industry standards.
  • Ensure that the verification process includes functional testing, accuracy checks, and comparison with reference standards.
  • Record the verification results, including any deviations, and take appropriate actions if the equipment does not meet the required criteria.
  • Calibrate the equipment if necessary before returning it to operational use.

    • 4.3 Calibration of Equipment:

    • Establish a calibration schedule based on equipment criticality and industry best practices.
    • Use calibrated reference standards with traceability to national or international standards for calibration purposes.
    • Follow the manufacturer’s guidelines and standard operating procedures for equipment calibration.
    • Document the calibration results, adjustments made, and the calibration due date for each piece of equipment.

    4.4 Equipment Labeling:

    • Label each equipment with a calibration status tag indicating the date of the last calibration and the next due date.
    • Clearly mark equipment that is under verification or calibration to prevent accidental use.
    • Remove “Out of Calibration” tags only after completing the verification and calibration processes successfully.

    5. Abbreviations

    SOP: Standard Operating Procedure
    QA: Quality Assurance

    6. Documents

    The following documents are relevant to this SOP:

    • Equipment Verification and Calibration Schedule
    • Equipment Maintenance Log
    • Calibration Certificates and Reports

    7. References

    Refer to the manufacturer’s guidelines and industry standards for specific equipment verification and calibration procedures.

    8. SOP Version

    This is version 1.0 of the SOP for Equipment Verification and Calibration, effective as of [Insert Date].

     

    See also  Quality Assurance: SOP for Bioburden Testing
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