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A Periodic Compliance Review Assessment

A periodic compliance review assessment for equipment and utility systems is a critical aspect of maintaining the quality, safety, and regulatory compliance of manufacturing and production processes. The Quality unit must oversee the review assessment. This assessment involves a comprehensive evaluation of equipment and utility systems to ensure they continue to meet the required standards and specifications and remain in a validated state.

Key Components of the Assessment:

  1. Calibration Records Review:

    • Calibration is the process of comparing the measurement accuracy of an instrument or device against a known standard.
    • During the compliance review, all calibration records for equipment and instruments should be examined. This includes checking whether the calibration intervals were followed and if any instruments were found to be out of calibration during the period.
  2. Preventative Maintenance Records Review:

    • Preventative maintenance involves scheduled inspections and servicing of equipment to prevent breakdowns and ensure optimal performance.
    • The assessment should include a review of preventative maintenance records to confirm that maintenance activities were performed as scheduled and that any identified issues were addressed promptly.
  3. Deviations Records Review:

    • Deviations refer to instances where equipment or processes did not perform as expected or deviated from established procedures.
    • The compliance review should assess the number and nature of deviations, as well as the corrective actions taken to resolve them.
  4. Change Control Records Review:

    • Change control is the process of documenting and managing changes made to equipment, processes, or systems.
    • The assessment should include a review of change control records to ensure that all changes were properly documented, justified, and validated, if necessary.
  5. Review of Log Books:

    • Log books associated with equipment and utility systems should be reviewed, if applicable. These records can provide valuable insights into the history and performance of the systems.
  6. Revalidation Based on Review Results:

    • Depending on the findings of the compliance review, revalidation may be necessary.
    • Periodic reviews should encompass either revalidation or a justified rationale for not conducting revalidation.
    • Revalidation involves performing additional testing or qualification activities to ensure that the equipment and utility systems are still capable of meeting their intended purpose and regulatory requirements and remain in a validated state.
    • The revalidation scope will be based on the results of the periodic assessment.
  7. Time Interval for Periodic Assessments:

    • The frequency of periodic compliance assessments can vary depending on the company and industry policies, the criticality of the equipment, design, and nature of equipment/systems, and regulatory requirements.
    • There is no common time interval for these assessments, which might be annual, biennial, or even every three years, but they can be more frequent for critical systems.
    • The chosen interval should align with industry best practices and regulatory expectations.

In summary, periodic compliance review assessments, overseen by the Quality unit, are essential for maintaining the quality and compliance of equipment and utility systems. These assessments involve a thorough examination of calibration, preventative maintenance, deviations, change control records, and, if applicable, log books. The results of these assessments can trigger revalidation activities to ensure continued compliance. The time interval for these assessments should be determined based on industry standards, regulatory requirements, and the criticality of the systems being evaluated.