Performance Qualification Protocol Template
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Performance Qualification Protocol

Prepared by:

[YOUR NAME]

Company Name:

[YOUR COMPANY NAME]

Department:

[YOUR DEPARTMENT]

Date:

[DATE]

I. Objective

The objective of this Performance Qualification (PQ) Protocol is to ensure that the [YOUR COMPANY NAME] meets predefined acceptance criteria and performs as intended under operational conditions. This protocol outlines the procedures, acceptance criteria, and responsibilities for conducting the PQ of the [YOUR COMPANY NAME].

II. Scope

This PQ Protocol applies to the [Your Company Name] located at [Production Facility A]. The PQ will be performed by qualified personnel by relevant standard operating procedures (SOPs) and regulatory requirements.

III. Responsibilities

  1. Project Manager: Oversees the entire PQ process and ensures that it is conducted in compliance with established protocols and timelines.

  2. Quality Assurance (QA) Representative: Reviews and approves the PQ Protocol. Monitors the execution of PQ activities to ensure compliance with regulatory requirements.

  3. Operations Personnel: Execute the PQ activities as per the protocol and provide necessary support.

  4. Maintenance Personnel: Ensure that the [YOUR COMPANY NAME] is properly maintained and calibrated for the PQ.

  5. Documentation Specialist: Maintains accurate records of all PQ activities and results.

IV. Equipment and Materials Required

  1. [YOUR COMPANY NAME]

  2. Calibration tools and standards

  3. Test materials specific to your processes

  4. Data logging equipment

  5. Environmental monitoring devices

V. Procedure

  1. Preparation:

    • Review the User Requirement Specifications (URS) and Design Qualification (DQ) documentation to understand the intended performance criteria of the [YOUR COMPANY NAME].

    • Ensure that the [YOUR COMPANY NAME] is installed and calibrated as per manufacturer specifications.

    • Verify that all necessary documentation, including SOPs, calibration certificates, and maintenance records, are available and up to date.

  2. Execution:

a. Initial System Checks:

  • Power on the [YOUR COMPANY NAME] and perform basic functionality tests.

  • Verify that safety features are operational and emergency stop procedures are in place.

b. Functional Testing:

  • Execute predefined test scripts to assess the functionality of the [YOUR COMPANY NAME] under normal operating conditions.

  • Document any deviations from expected performance and investigate root causes.

c. Performance Testing:

  • Conduct performance tests under simulated operational conditions to evaluate the [YOUR COMPANY NAME] against acceptance criteria.

  • Measure key performance parameters such as accuracy, precision, speed, and reliability.

d. Data Integrity Testing:

  • Verify the integrity of data generated by the [YOUR COMPANY NAME] through data logging, recording, and retrieval procedures.

  • Ensure compliance with data integrity regulations and guidelines.

e. Environmental Conditions Testing:

  • Validate the performance of the [YOUR COMPANY NAME] under varying environmental conditions (e.g., temperature, humidity) as specified in the URS.

f. Operational Qualification (OQ):

  • If applicable, ensure that any OQ requirements are addressed as part of the PQ process.

VI. Documentation

  • Record all test results, observations, and deviations in the PQ Report.

  • Include details of any corrective actions taken to address deviations.

  • Obtain signatures from relevant personnel to attest to the completion and accuracy of the PQ activities.

VII. Conclusion

  • Review the PQ Report for completeness and accuracy.

  • Submit the PQ Report to the QA Representative for review and approval.

  • Upon approval, the [YOUR COMPANY NAME] is considered qualified for operational use.

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