Standard Operating Procedure for Equipment Validation of AHU in Aseptic Areas

Purpose

This SOP outlines the validation process for the Air Handling Unit (AHU) used in the Aseptic Area, ensuring compliance with regulatory standards and maintaining product integrity.

Scope

This procedure applies to the validation of the AHU serving classified rooms within the Engineering area, utilized for HVAC in sterile injectables/aseptic manufacturing processes.

Definitions

• Aseptic Area: Controlled environment where sterile products are manufactured.
• AHU: Air Handling Unit, a system that regulates and circulates air.
• Validation: Establishing documented evidence that a process or system consistently produces a result meeting predetermined specifications.

Roles

• Validation Team: Responsible for planning, executing, and documenting validation activities.
• Engineering Department: Provides technical support and resources for validation activities.
• Quality Assurance: Ensures compliance with regulatory requirements and reviews validation documentation.

Lifecycle Procedure

1. Design Qualification (DQ): Ensure user requirements are defined and documented.
2. Installation Qualification (IQ): Verify that the AHU is installed according to specifications.
3. Operational Qualification (OQ): Confirm that the AHU operates within the defined limits.
4. Performance Qualification (PQ): Validate that the AHU consistently performs as intended under actual operating conditions.

Good Documentation Practices (GDP) Controls

All validation records must be maintained in accordance with GDP principles, ensuring accuracy, consistency, and completeness.

Acceptance Criteria Governance

Validation activities must adhere to the acceptance criteria outlined in the following documents:

• User Requirement Specification (URS)
• Annex 1: Manufacture of Sterile Medicinal Products
• Annex 11: Computerized Systems
• Annex 15: Qualification and Validation

Calibration/PM Governance

The AHU must undergo regular calibration and preventive maintenance as per the established schedule to ensure continued compliance and performance.

Change Control Triggers

Any changes to the AHU or its operating conditions must initiate a change control process, including re-evaluation of the validation status.

Revalidation Triggers and Periodic Review

Revalidation must occur every 6 to 12 months or upon significant changes to the system or process to ensure ongoing compliance and performance.

Records/Attachments List

• Validation Master Plan
• Validation Protocols (DQ, IQ, OQ, PQ)
• Calibration Records
• Maintenance Logs
• Change Control Documentation