Standard Operating Procedure (SOP) for Equipment Performance Qualification (PQ)

Introduction:
Ensure your equipment consistently performs as intended under real-world conditions with our Standard Operating Procedure (SOP) for Equipment Performance Qualification (PQ). Specifically developed for highly regulated environments such as pharmaceutical, biotechnology, and medical device industries, this SOP outlines a compliant, reproducible, and documented process for verifying that equipment meets all operational specifications in its actual usage environment.

Overview:
The SOP for Equipment Performance Qualification (PQ) provides a critical framework for demonstrating that equipment, once installed and operational, can reliably perform to required standards during routine production. This SOP ensures compliance with GMP regulations and supports the validation lifecycle by integrating PQ into a broader equipment qualification strategy (IQ, OQ, PQ).

Key Sections Included in the SOP:

1. Purpose:
   Defines the goals of Performance Qualification—to confirm and document that equipment performs as expected during normal operations, under defined process parameters.
2. Scope:
   Applies to all GMP-regulated equipment requiring formal PQ before being released for use in production or testing, particularly equipment impacting product quality or patient safety.
3. Responsibilities:
   Outlines the duties of Validation, Quality Assurance, Engineering, and User departments in the planning, execution, and approval of PQ activities.
4. Pre-Requisite Requirements:
   • Confirms that Installation Qualification (IQ) and Operational Qualification (OQ) have been successfully completed.
   • Verifies that SOPs, calibration, and training are in place prior to starting PQ.
5. Performance Qualification Plan:
   • Describes how to develop a PQ protocol including objective, test parameters, acceptance criteria, sampling plan, and data analysis methodology.
   • Requires Quality Unit approval prior to execution.
6. Test Execution and Data Collection:
   • Provides step-by-step guidance on conducting PQ runs using typical operating conditions, load configurations, and product types.
   • Emphasizes the need to record environmental and process data during each run.
7. Acceptance Criteria and Evaluation:
   • Defines criteria for evaluating test results against established specifications.
   • Details the method for statistical analysis or trend evaluation, where applicable.
8. Deviation Handling and Non-Conformance:
   • Explains procedures for identifying, documenting, and investigating deviations from expected performance.
   • Requires CAPA (Corrective and Preventive Action) when results fall outside acceptable limits.
9. Documentation and Approval:
   • Requires comprehensive documentation of test execution, data, results, deviations, and justifications.
   • Specifies approval workflows including signatures from responsible departments and final QA release.
10. Requalification Triggers:

• Lists conditions that require partial or full PQ re-execution, such as major repairs, relocation, process changes, or observed failures.

1. Record Retention:

• Establishes document control, archival, and retention timelines in line with regulatory expectations (e.g., FDA 21 CFR Part 211, EU GMP Annex 15).

1. Training and Competency:

• Stipulates training and qualification requirements for individuals executing PQ procedures.

Why Download This SOP?

• Meet Global Regulatory Expectations: Aligns with GMP, FDA, EMA, and ICH guidelines for validation.
• Strengthen Validation Lifecycle: Completes the IQ/OQ/PQ sequence to validate equipment suitability.
• Protect Product Quality: Ensures equipment functions correctly under production conditions.
• Streamline Audit Readiness: Provides complete traceability and approval for performance verification.
• Reduce Operational Risk: Identifies variability or potential failure points before routine use.

Support and Contact Information:
For questions or additional guidance on equipment performance qualification procedures, please reach out to our support team. We’re here to help you meet the highest standards of equipment validation and regulatory compliance.