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CQV in the Pharmaceutical Industry: Best Practices for FAT, SAT, IQ/OQ

November 1, 2024Tai Van
CQVGMPPharmaceutique

CQV in the Pharmaceutical Industry: Best Practices for FAT, SAT, IQ/OQ

Qualification and Validation (CQV) is a fundamental pillar of the pharmaceutical industry. With over 20 years of experience in this field, we share best practices to ensure GMP compliance while optimizing timelines and costs.

CQV Process Overview

The CQV process generally follows this sequence: 1. FAT (Factory Acceptance Test) - Tests at manufacturer 2. SAT (Site Acceptance Test) - On-site tests 3. IQ (Installation Qualification) - Installation qualification 4. OQ (Operational Qualification) - Operational qualification 5. PQ (Performance Qualification) - Performance qualification

FAT: Factory Acceptance Test

Objectives

  • Verify that equipment meets specifications before shipment
  • Validate functionality in a controlled environment
  • Identify and correct issues before installation

Best Practices

1. Exhaustive Preparation

  • Clearly define acceptance criteria before FAT
  • Prepare detailed test protocols
  • Ensure all necessary documents are available

2. Systematic Testing

  • Follow a structured test plan
  • Document each test with evidence (photos, logs, screenshots)
  • Test all operating modes, including edge cases

3. Deviation Management

  • Document any deviation immediately
  • Assess impact on GMP compliance
  • Define a corrective action plan before acceptance

Field Experience

During a recent FAT for a water purification system, we identified 12 minor deviations and 2 major ones. Thanks to rigorous documentation and effective communication with the manufacturer, all deviations were corrected before shipment, avoiding costly on-site delays.

SAT: Site Acceptance Test

Objectives

  • Verify that equipment works correctly after installation
  • Validate integration with existing systems
  • Confirm that installation conditions are compliant

Best Practices

1. Preliminary Verification

  • Ensure mechanical installation is complete
  • Verify electrical and network connections
  • Validate environment (temperature, humidity, cleanliness class)

2. Integration Testing

  • Test integration with supervision systems (SCADA, MES)
  • Validate communications with other equipment
  • Verify alarms and error handling

3. Documentation

  • Document all tests with evidence
  • Update P&ID diagrams and electrical schematics if necessary
  • Prepare documents for IQ

IQ: Installation Qualification

Objectives

  • Verify that equipment is installed according to specifications
  • Document exact installation configuration
  • Validate that all components are correctly installed

Typical IQ Content

1. Document Verification

  • Installation plans
  • Compliance certificates
  • Technical manuals

2. Physical Verification

  • Location and anchoring
  • Electrical connections
  • Fluid connections (water, air, steam)
  • Network connections

3. Software Verification

  • Firmware version
  • Software configuration
  • Configuration backup

Modern Tools

Digital tools like Kneat and Veeva Vault greatly facilitate IQ management by enabling:

  • Electronic signature
  • Real-time progress tracking
  • Integration with other validation systems

OQ: Operational Qualification

Objectives

  • Verify that equipment operates according to specifications under normal use conditions
  • Validate all operating modes
  • Confirm compliance with GMP requirements

Typical Tests

1. Functional Tests

  • All operating modes
  • Alarm management
  • Safety and emergency stops

2. Performance Tests

  • Nominal capacity
  • Energy efficiency
  • Product quality

3. Robustness Tests

  • Input parameter variations
  • Disturbance management
  • Error recovery

Field Experience

On a recent project, we reduced OQ time by 40% by using automated scripts for repetitive tests. This allowed us to focus on critical tests requiring human expertise.

PQ: Performance Qualification

Objectives

  • Demonstrate that the system operates reproducibly under real production conditions
  • Validate finished product quality
  • Confirm compliance with product specifications

Approach

PQ is generally performed on several production batches to demonstrate reproducibility. It must be performed with real raw materials and production conditions.

Deviation and Change Management

Basic Principle

Any deviation or change must be: 1. Documented immediately 2. Assessed for its impact on validation 3. Approved according to established procedures 4. Followed until resolution

Recommended Tools

  • Trackwise: Deviation and CAPA management
  • Kneat: Digital validation management
  • Veeva Vault: Document management

Conclusion

A well-structured CQV approach is essential to ensure GMP compliance while optimizing timelines and costs. Best practices include:

1. Exhaustive preparation before each phase 2. Rigorous documentation with evidence 3. Use of modern digital tools 4. Effective communication between all stakeholders 5. Proactive deviation management

At Vanguard Engineering Solutions, we support our clients throughout the CQV process, from initial planning to final validation, ensuring GMP compliance and resource optimization.