The Cleanroom Documentation Package (CDP) is a critical set of documents that ensures cleanrooms meet industry standards and regulations for use in controlled environments, such as pharmaceutical or biotech manufacturing. The Cleanroom Qualification and Validation (CQV) process is a structured approach to validating that the cleanroom operates as required and can maintain the necessary cleanliness levels, environmental conditions, and operational parameters. Below is a list of CQV documentation required for cleanrooms, along with a brief description of each document:

Cleanrooms | Cleanroom Consulting | Biotech Cleanrooms

1.     Cleanroom CQV-Construction Plan

Purpose:
The Construction Plan outlines the scope, timeline, resources, and methodologies for building the cleanroom facility, ensuring the project aligns with operational needs and regulatory requirements.

Contents:

• Project scope and objectives
• Construction schedule and milestones
• Resource planning (personnel, equipment, materials)
• Risk assessment and mitigation strategies
• Design specifications for HVAC, lighting, air filtration, and other critical systems
• Project management structure and roles
• Compliance with regulatory standards (e.g., GMP, ISO)

Construction Plan for a Biologics Manufacturing Facility

2.    User Requirements Specification (URS)

Purpose:
The URS defines the specific requirements the cleanroom must meet based on the intended application. It serves as the foundation for the cleanroom’s design and validation process.

Contents:

• Functional requirements (e.g., air cleanliness levels, temperature, humidity, pressure differentials)
• Process requirements (e.g., product or equipment compatibility with the cleanroom environment)
• Safety standards and operational limits
• GxP compliance requirements
• Environmental monitoring criteria
• Utilities and system specifications (e.g., HVAC, electrical, water systems)

User Requirements Specification | Cleanrooms | Cleanroom URS

3.    Validation Plans

Purpose:
The Validation Plans provide a structured approach to qualifying and validating the cleanroom, ensuring it operates as intended and meets all relevant regulatory requirements.

Contents:

• Overview of the qualification strategy (IQ, OQ, PQ)
• Detailed test plans for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
• Roles and responsibilities of personnel
• Testing protocols and procedures
• Acceptance criteria for each qualification phase
• Risk management strategies for validation activities
• Timeline for completion of qualification tasks

4.    Installation Qualification (IQ)

Purpose:
IQ verifies that the cleanroom and its critical systems (e.g., HVAC, filtration, utilities) have been installed correctly and meet the design specifications in the URS.

Contents:

• Verification of equipment installation (e.g., air handling units, HEPA filters)
• System documentation review (e.g., design drawings, equipment manuals)
• Calibration of installed equipment
• Inspection of utilities and infrastructure
• Compliance checks with specifications
• Performance of installation tests (e.g., airflow patterns, pressure differentials)

Biologics Manufacturing I Cleanroom Design Qualification Process

5.    Operational Qualification (OQ)

Purpose:
OQ ensures that the cleanroom and its systems operate as designed under normal conditions. It confirms that systems function according to predefined operational parameters.

Contents:

• Functional testing of cleanroom systems (e.g., air circulation, pressure control, temperature)
• Verification of system performance under load (e.g., number of personnel, equipment in operation)
• Testing of critical environmental parameters (e.g., particulate counts, airflow, temperature and humidity stability)
• Operational system checks (e.g., pressure differentials, airflow validation)
• Compliance with URS and regulatory standards

6.    Performance Qualification (PQ)

Purpose:
PQ verifies that the cleanroom performs consistently and reliably under typical operating conditions over time, ensuring the cleanroom environment is stable for ongoing operations.

Contents:

• Long-term performance testing (e.g., continuous monitoring of air quality, temperature, humidity, and pressure)
• Validation of system robustness under real production conditions (e.g., testing with operational equipment running)
• Verification that cleanroom maintains required cleanliness and environmental conditions throughout routine operations
• Documentation of performance data over a defined qualification period
• Analysis of system stability and consistency over time

Cleanroom EMPQ | Cleanrooms | Cleaning Validation

7.    Summary Reports

Purpose:
Summary reports compile the results of the IQ, OQ, and PQ phases and provide a final review of the cleanroom’s qualification status, confirming its suitability for use.

Contents:

• Overview of the qualification process (IQ, OQ, PQ) and outcomes
• Summary of testing results and deviations (if any)
• Corrective actions taken and resolutions
• Final assessment of cleanroom readiness
• Recommendations for continued monitoring and maintenance
• Certification of compliance with regulatory requirements

8.    Operational Standard Operating Procedures (SOPs)

Purpose:
Operational SOPs provide detailed instructions for the cleanroom’s daily operations, maintenance, and monitoring. These procedures ensure consistent, reliable operation and ongoing compliance with GxP regulations.

Contents:

• Cleanroom entry and gowning procedures
• Cleaning and disinfection protocols (e.g., surface cleaning, air handling systems maintenance)
• Environmental monitoring procedures (e.g., particle count, air quality checks)
• Equipment maintenance and calibration schedules
• Emergency procedures (e.g., system failures, contamination incidents)
• Change control procedures for modifying cleanroom operations
• Documentation practices (e.g., logbooks, maintenance records)

Role of GxP Cellators in Cleanroom Documentation and Operations:

GxP Cellators, or similar entities, are vital in providing and executing the Cleanroom Documentation Package. They are involved in:

• Preparing and delivering the full documentation package covering all cleanroom qualification and validation aspects.
• Execute qualification activities (IQ, OQ, PQ), perform required tests, and ensure systems operate within specifications.
• Provide support for regulatory compliance and ensure all documentation meets GxP standards (e.g., FDA, EMA).
• Train staff in operational procedures (SOPs) and guide proper cleanroom operations and maintenance practices.
• Supporting ongoing monitoring and requalification efforts to maintain cleanroom performance over time.

This package ensures that the cleanroom is fit for use, compliant with regulations, and capable of maintaining a controlled environment suitable for the intended applications, whether for pharmaceutical production, medical device manufacturing, or other regulated industries.

For any assistance needed with cleanroom documentation design, please get in touch with GxP Cellators at .

Cleanroom Consultants I Cleanroom CQV I Biologics Project