Performance Qualification (PQ)

Performance Qualification (PQ) is the documented verification that facilities, systems, and equipment can perform effectively and reproducibly based on the approved process method and product specifications, under routine operating conditions.

Overview

Performance Qualification (PQ) is the documented verification that facilities, systems, and equipment consistently perform according to approved process methods and product specifications under real or simulated production conditions. It ensures that systems, when operated within their defined parameters, can reproducibly produce quality outputs, aligning with EU GMP Annex 15 expectations.

PQ is the final stage in the qualification lifecycle and follows successful Installation Qualification (IQ) and Operational Qualification (OQ). However, concurrent PQ may be justified in some scenarios—such as for processes with extensive historical data or well-characterized performance—based on a risk-based validation strategy.

Objectives of PQ

The purpose of PQ is to:

  • Demonstrate Consistent Performance: Prove that equipment and processes reliably deliver acceptable results during routine or simulated production runs.
  • Validate Use with Actual Materials: Confirm that systems function effectively using real or representative production materials.
  • Verify Process Robustness: Establish that the process remains in control across the full range of intended operational conditions.
  • Support Release for GMP Use: Provide documented evidence that the system is suitable for ongoing commercial or clinical manufacturing.
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Main Activities

1. Sequential Validation and Integration

  • Standard Approach: PQ is typically executed only after IQ and OQ are successfully completed, ensuring the system is correctly installed and operational.
  • Concurrent Validation (When Justified): PQ may be combined with OQ or process validation in cases where substantial development data or process knowledge already exists, particularly in tech transfers or legacy systems.

2. Scope of PQ Testing

PQ must reflect actual manufacturing conditions and cover operational variability. It includes:

  • Use of Production Materials: Conduct testing with real materials, consumables, and production volumes to assess true operational performance.
  • Qualified Substitutes: If actual materials are not feasible, validated surrogates or simulated products with equivalent behaviour may be used—with justification.
  • Worst-Case Conditions: Include tests using worst-case batch sizes, fill volumes, or process limits to challenge the system's full operational capability.

3. Operational Range Testing

  • Full Range Validation: Confirm system performance at minimum, nominal, and maximum setpoints for all critical parameters (e.g., time, temperature, pressure, speed).
  • Boundary Testing: Ensure process controls are maintained even under edge-case operating conditions.
  • Leverage Existing Data: Incorporate documented evidence from development studies, scale-up runs, or design verification to support operating range definitions.

4. Sampling Frequency and Strategy

  • Risk-Based Sampling Plan: Design a sampling strategy based on the criticality of the process parameters and product attributes.
  • Adequacy of Data: Ensure sufficient sample size and frequency to establish statistical confidence in repeatability and reproducibility.
  • Documentation: Justify sampling plans and data requirements based on process risk and regulatory expectations.

5. Product and Process Performance Verification

  • Product Testing: Perform all applicable in-process and finished product tests (e.g., sterility, dose accuracy, sealing integrity, diagnostic accuracy).
  • In-Process Controls: Monitor intermediate process steps where variation may affect final product quality.
  • Trend Analysis and Statistics: Evaluate performance trends using tools like control charts, standard deviation, or process capability indices.

6. Deviation and Non-Conformance Management

  • Deviation Documentation: Record and investigate any test or process deviations from the PQ protocol.
  • Root Cause Analysis: Conduct a structured investigation (e.g., 5 Whys, FMEA) for each deviation.
  • Corrective and Preventive Actions (CAPA): Implement and document remediation plans, with retesting where necessary.
  • Impact on PQ Acceptance: Assess how any deviation may affect the overall qualification outcome and readiness for GMP use.
Flowchart illustrating performance qualification process with five stages: test strategy development, verification of critical parameter, verification of functional range, data evaluation and reporting; includes icons and brief descriptions of each step.

PQ Documentation Requirements

A robust Performance Qualification (PQ) process must be fully documented to demonstrate that equipment, systems, or processes perform consistently and reliably under actual operating conditions. Complete, accurate, and traceable documentation ensures compliance with GMP, FDA process validation guidance, and ISO 13485.

1. Performance Qualification Protocol

The PQ protocol is the cornerstone of a controlled and compliant performance validation effort:

  • Defined Scope and Objectives: Clearly identify what is being qualified (equipment, process, or system) and its intended role within commercial operations.
  • Roles and Responsibilities: Assign responsibilities across Validation, QA, Production, Engineering, and other relevant departments.
  • Test Strategy and Methodology: Detail how performance will be evaluated, including the number of batches, process conditions, and sampling plans.
  • Acceptance Criteria: Set predefined, measurable limits aligned with product specifications and critical process parameters.
  • References and Alignment: Link to relevant SOPs, work instructions, risk assessments, and regulatory standards (e.g., EU GMP Annex 15, ICH Q8/Q9/Q10).

2. Test Plans and Execution Procedures

Well-defined test procedures ensure repeatability and control throughout PQ execution:

  • SOPs and WI References: Use controlled procedures to guide testing and sampling activities.
  • Sampling Strategy: Justify sample locations, quantities, and frequency based on risk and process knowledge.
  • Identification of Test Units: Include batch numbers, lot codes, equipment identifiers, and any specific material characteristics.

3. Test Execution Records and Data Integrity

Accurate and authentic test records are essential for demonstrating consistent performance under commercial conditions:

  • Raw Data and Test Outputs: Preserve original records from each PQ batch in accordance with ALCOA+ principles.
  • Operational Observations: Record any abnormal conditions, environmental impacts, or operator notes during test execution.
  • Data Evaluation: Apply appropriate statistical tools (e.g., process capability, control charts, trending) to confirm stability and reproducibility.

4. Calibration and Instrument Verification

All measurement systems must be verified to ensure data accuracy and process control:

  • Current Calibration Certificates: Document traceable calibration for all measurement devices used during PQ.
  • Pre-Use Verification: Ensure instrument calibration status was reviewed and confirmed before data collection.

5. Deviation Handling and CAPA Records

All process or data anomalies must be documented and resolved in a compliant manner:

  • Deviation Documentation: Include detailed logs of any test failures, process deviations, or unplanned events.
  • Root Cause and Impact Assessment: Conduct thorough investigations to assess the cause, product impact, and system risks.
  • Corrective Actions and Re-Testing: Record any required requalification, re-testing, or long-term monitoring triggered by the deviation.

6. Performance Qualification Summary Report

The summary report consolidates the entire PQ effort, providing a traceable and reviewable validation record:

  • Protocol Execution Summary: Recap all PQ batches, tests performed, and results obtained.
  • Deviation Summary and Closure Status: List deviations, CAPAs, and resolution actions.
  • Final Conclusions: Provide a qualified statement that the system or process meets operational requirements and is fit for commercial use.
  • Recommendations for Lifecycle Validation: Address next steps such as requalification schedules, continued process verification (CPV), or process monitoring strategies.
  • Signatory Approvals: Secure sign-off from QA, Validation, and all responsible departments in alignment with Annex 15 and 21 CFR Part 211.180.

When is PQ Required?

Performance Qualification is mandatory in situations where operational performance and process output must be proven under real-world, production-scale conditions. Key scenarios include:

  • Commissioning of New Equipment, Facilities, or Systems
  • Technology Transfers or Site Expansions
  • Post-Upgrade Requalification After Major Modifications
  • Resumption of Operations After Extended Downtime or Repairs
  • Initial Validation of Manufacturing Processes for New Products

PQ confirms the consistent delivery of quality outcomes in line with your product and process requirements. It provides the final validation stage before full-scale release and underpins Stage 3 – Continued Process Verification (CPV) per FDA, EU GMP, and ISO 13485 requirements.

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Make it

Qualification with Confidence

Performance Qualification (PQ) is where validation meets reality. It’s the critical final step that confirms your systems, equipment, and processes operate consistently, reliably, and within defined parameters under actual production conditions. A successful PQ demonstrates not only that your process performs as intended, but that it’s ready for routine use—with all quality, safety, and compliance requirements met.

At SciReg Consulting, we partner with you to design and execute robust PQ strategies that go beyond minimum compliance:

  • Risk-based protocol development: Tailored to your process complexity, product classification, and regulatory environment—fully aligned with EU GMP Annex 15, FDA process validation guidance, and ISO 13485.
  • On-site and remote support: Covering protocol execution, batch sampling, operator oversight, environmental monitoring, and real-time troubleshooting of performance issues.
  • Statistical data analysis and trending: Applying appropriate tools and techniques to demonstrate process consistency, capability, and control—supporting your Stage 3 – Continued Process Verification (CPV).
  • Full documentation lifecycle management: Including calibration traceability, deviation handling, and CAPA integration—all prepared to withstand regulatory scrutiny from authorities or notified bodies.
  • Strategic alignment with requalification and periodic review: Ensuring long-term validation planning, sustainable compliance, and operational resilience.

Whether you’re launching a new facility, introducing a novel product, or scaling a validated process, SciReg ensures your PQ is not just a milestone, but a foundation for ongoing performance excellence.

Partner with SciReg Consult to build and execute a qualification framework that meets today’s ATMP regulatory requirements—and evolves with tomorrow’s innovations.