Published on 07/12/2025
Performance Qualification (PQ) in Pharma: How to Validate Equipment Under Real Conditions
Performance Qualification (PQ) is the final stage in the equipment qualification lifecycle following Installation Qualification (IQ) and Operational Qualification (OQ). PQ confirms that equipment consistently performs as intended under actual process conditions using approved materials, SOPs, and personnel. It is a critical step in ensuring GMP compliance, product quality, and regulatory confidence.
This step-by-step guide explains how to effectively execute PQ, build robust protocols, define sampling plans, and establish acceptance criteria aligned with FDA, EMA, and WHO expectations.
What Is Performance Qualification (PQ)?
PQ verifies the equipment’s ability to perform reproducibly under real-world operating conditions. Unlike OQ, which uses simulated inputs and predefined limits, PQ utilizes production materials, trained operators, and standard operating procedures (SOPs) to validate performance.
PQ typically includes three consecutive successful production runs under normal and worst-case scenarios. The scope of PQ should be based on a risk-based assessment as per ICH Q9 and should tie back to the User Requirement Specification (URS).
Regulatory Basis for PQ
- FDA Guidance (2011): PQ should demonstrate consistent performance throughout routine operations.
- EMA Annex 15: PQ must include process simulation using actual materials and parameters.
- ICH
PQ Protocol Structure
An effective PQ protocol includes the following key components:
- Protocol Number and Title
- Objective and Scope
- Equipment Details and ID
- Reference Documents and SOPs
- List of Process Parameters and Test Equipment
- Sampling Plan and Locations
- Acceptance Criteria for Each Test
- Data Recording Format
- Deviation Management
- Summary Report Template
Test Parameters in PQ
Tests conducted during PQ depend on the equipment but generally include:
- Process Output Verification (e.g., batch weight, volume, fill accuracy)
- In-Process Controls (e.g., pH, temperature, pressure)
- Environmental Monitoring (e.g., viable and non-viable counts)
- Alarm and Sensor Performance under Load
- Worst-Case Load Testing
PQ Sampling Strategy
Sampling must be statistically justified and reflect the full range of operating conditions. A proper sampling plan should include:
- Number of Batches: Minimum 3 consecutive conforming batches
- Locations: Top, middle, and bottom positions in vessels or chambers
- Frequency: Start, middle, end of run
- Sample Types: In-process, final product, rinse samples (for CIP systems)
Example: PQ Sampling Plan for Autoclave
| Position | Location | Sensor Type | Pass Criteria |
|---|---|---|---|
| 1 | Top-Left Corner | Temperature Probe | 121°C for 15 mins |
| 2 | Center | Biological Indicator | No growth post incubation |
| 3 | Bottom-Right | Pressure Sensor | ≥15 psi |
Acceptance Criteria
All results must meet predefined acceptance limits, documented in the protocol. Criteria should be:
- Objective and measurable
- Based on URS and regulatory standards
- Consistent across all batches
Example Acceptance Limits
| Parameter | Specification |
|---|---|
| Temperature Uniformity | ±1.5°C |
| Filling Accuracy | ±2% of target volume |
| Sterility (media fill) | 0 positive units/3 runs |
| Relative Humidity | 45% ± 5% |
PQ Execution Steps
- Approve PQ protocol
- Conduct training for operators and validation team
- Verify calibration of instruments
- Perform 3 consecutive validation runs under standard conditions
- Collect and analyze all samples
- Document all results and observations
- Log deviations and corrective actions
- Prepare and approve PQ summary report
Link Between PQ and Process Validation
PQ is closely tied to Stage 2 (Process Qualification) and Stage 3 (Continued Process Verification) of the process validation lifecycle. Successful PQ ensures that the equipment supports a validated process that produces consistent results.
PQ Documentation Checklist
- PQ Protocol and Raw Data Sheets
- Batch Records of PQ Runs
- Sample Log and Test Results
- Calibration Certificates
- Deviation Forms and CAPA Reports
- PQ Summary Report with QA Approval
Common Pitfalls in PQ
- Inadequate sampling frequency or location coverage
- Failure to simulate real-world scenarios
- Omitting operator variability in PQ runs
- Uncalibrated sensors during testing
- Incomplete documentation and sign-offs
Conclusion
Performance Qualification (PQ) ensures your equipment can reliably support validated processes under routine GMP conditions. By designing clear protocols, implementing robust sampling strategies, and defining measurable acceptance criteria, you can execute PQ with confidence and regulatory readiness.
For downloadable PQ templates, validation master plans, and test case libraries, visit PharmaSOP.in. Learn more about integrated equipment lifecycle management at PharmaValidation.in.