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PW Requalification and Periodic Review Pharma Systems

During a project in a South American pharmaceutical company, the team validated the purified water (PW) system three years earlier and released it for operation. However, they did not perform any structured periodic reassessment after the original qualification. As a result, clear gaps emerged in PW requalification and broader periodic review pharma oversight practices. Although the documentation showed validation approval, the company did not actively confirm the validated state over time. Therefore, Zamann Pharma Support performed a structured lifecycle assessment of the purified water system and delivered clear, risk-based recommendations to restore validated state control through formal PW requalification and periodic review pharma governance.

Challenges Faced

A detailed GAP analysis in Quality Management Systems is essential for identifying process deficiencies effectively.
  • Periodic Requalification: The company did not conduct periodic requalification after extended system operation. Consequently, the team could not formally confirm continued validated state control.
  • Preventive Maintenance: The organization did not establish a preventive maintenance program. Instead, the team relied on unstructured interventions that did not support lifecycle stability.
  • Historical Trending: The company did not perform long-term trending for TOC, CFU, temperature, or pressure. Therefore, the team could not identify gradual performance drift.
  • Annual Validated State Assessment: Management did not document an annual confirmation of validated status. As a result, they lacked objective evidence of ongoing control.
  • Reactive Maintenance Approach: Over time, the team handled maintenance reactively rather than proactively. Consequently, the system became less predictable.

Zamann Pharma Support’s Approach

  • Detailed Assessment: First, the team verified the last executed IQ/OQ/PQ activities. Then, they examined whether the company had performed periodic requalification since initial validation. In addition, they reviewed maintenance records, deviation history, and historical performance data. As a result, the assessment confirmed that the organization had not formally reassessed the validated state during three years of operation.
  • Lifecycle Gap Identification: Next, the team identified the absence of a preventive maintenance strategy and structured historical trending for TOC, CFU, temperature, and pressure. Moreover, they confirmed that the company had not documented annual validated state confirmation. Although validation documentation existed, the organization did not maintain active lifecycle control. Therefore, the absence of structured PW requalification and periodic review pharma governance created compliance exposure.
  • Requalification and Periodic Review Structuring: Subsequently, the team established a formal periodic requalification plan. They defined clear reassessment intervals, trending review frequency, and validated state confirmation criteria. In parallel, they structured documentation templates to ensure that annual review activities were recorded within the quality system.
  • Preventive Maintenance and Trending Integration: After that, the team converted maintenance from reactive intervention to scheduled preventive activities. In addition, they formalized and documented historical performance trending for critical parameters. Consequently, the organization could evaluate system behavior proactively rather than respond to deviations.
  • Governance Alignment: Finally, the team integrated validated state review responsibilities into the Quality Management System. They assigned annual reassessment ownership and incorporated lifecycle performance indicators into routine quality oversight meetings. As a result, the company strengthened continuous lifecycle control instead of relying on one-time validation.

Results Achieved

  • Structured Periodic Reassessment Implemented: The company introduced a defined periodic review cycle. Consequently, they replaced informal follow-up with documented reassessment aligned with lifecycle expectations.
  • Preventive Maintenance Strategy Established: The team replaced reactive interventions with scheduled preventive maintenance. As a result, operational variability decreased and system stability improved.
  • Formalized Historical Performance Trending: The organization structured and documented trending for TOC, CFU, temperature, and pressure. Therefore, the team gained early visibility of performance drift.
  • Annual Validated State Review Embedded: Management integrated annual validation status assessment into the quality governance framework. Consequently, they ensured continuous confirmation of system control.
  • Improved System Predictability: Through structured lifecycle monitoring and oversight, the client regained objective assurance that the purified water system remained within a controlled and validated state.
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GMP qualification and lifecycle validation activities including IQ, OQ, and PQ supporting inspection readiness in pharmaceutical manufacturing.
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Qualification and Validation for GMP Systems

Our team supports the planning, execution, and maintenance of qualification and validation activities, including IQ, OQ, and PQ, to keep GMP-regulated systems compliant and under control.

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FAQ

1. How often should PW requalification be performed within a periodic review pharma framework in a GMP environment?

Most regulated sites define PW requalification as part of their periodic review pharma strategy every 2–3 years.

2. Can a validated water system lose its validated state without technical failure?

Yes. If no periodic review, trending analysis, or lifecycle reassessment is performed, the validated state cannot be objectively demonstrated during inspection.

3. What evidence do inspectors typically request during a PW system review?

Inspectors usually request historical trending data (TOC, CFU, temperature, pressure), preventive maintenance records, deviation logs, and documented confirmation that the validated state remains controlled.