Pharma CQV: meaning, FAT, SAT, IQ, OQ and PQ

CQV stands for commissioning, qualification and validation. Commissioning prepares and checks the technical operation of the installation. Qualification provides documented evidence that equipment and systems are installed and operate for their intended use. Validation addresses the process’s ability to perform reproducibly against predefined criteria.

Terminology and responsibilities vary with the site quality system. ICH Q7, published by FDA, defines DQ, IQ, OQ and PQ for the qualification of critical equipment and systems. The ISPE Commissioning & Qualification guide describes an integrated science- and risk-based approach.

CQV Process Overview

The stages below provide a common outline. Their order, combination and approval depend on the project and its QMS: 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

Good 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

SAT: Site Acceptance Test

Objectives

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

Good 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

Test automation

Test scripts can handle repetitive checks. Their use and result review must be defined in the qualification strategy; time savings require measurement on the relevant scope.

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 uses the equipment, systems, materials, methods and teams under the intended production conditions. The number of batches and sampling strategy need a rationale based on process knowledge and risk. FDA does not prescribe one universal number of batches for every process.

Connect CQV, GAMP 5 and ISA-88

GAMP 5 guides the life cycle of GxP computerized systems and verification proportionate to risk. ISA-88 and IEC 61512 structure batch-control models, procedures and recipes. These frameworks can make requirements and tests easier to follow, but they do not replace the QMS or quality approval.

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

Define scope before starting protocols

Scoping identifies the systems, applicable requirements, available documents, interfaces, roles and acceptance criteria. It also states who writes, executes, reviews and approves each deliverable. Without that split, technical deviations and quality decisions become confused.

Vanguard Systems prepares and executes FAT/SAT protocols and IQ/OQ activities within its technical scope. Final quality approval remains with the client. The CQV qualification and validation service describes the work offered.