Standard Operating Procedure for Validation of Manual Inspection Booth

Purpose: This SOP outlines the validation process for the Manual Inspection Booth used for the inspection of Nasal & Otic Products to ensure compliance with regulatory requirements and operational efficiency.

Scope: This procedure applies to the Manual Inspection Booth utilized in the production area for both sterile and non-sterile Nasal & Otic products.

Definitions:

• Equipment Validation: The process of ensuring that equipment operates according to its intended purpose and meets regulatory standards.
• Criticality: Major – Indicates significant impact on product quality and patient safety.
• Product Impact: Direct – The equipment directly influences the quality of the product.

Roles:

• Validation Team: Responsible for executing the validation protocols and documentation.
• Quality Assurance: Ensures compliance with regulations and reviews validation documentation.
• Production Personnel: Operate the equipment and provide feedback on its performance.

Lifecycle Procedure:

1. Design Qualification (DQ): Verify that the equipment design meets the requirements set forth in the User Requirements Specification (URS).
2. Installation Qualification (IQ): Confirm that the equipment is installed correctly and in accordance with manufacturer specifications.
3. Operational Qualification (OQ): Validate that the equipment operates as intended under normal operating conditions.
4. Performance Qualification (PQ): Confirm that the equipment consistently performs its intended function in a controlled environment.

Good Documentation Practices (GDP) Controls: All validation activities must be documented in accordance with established GDP standards, ensuring traceability and accountability.

Acceptance Criteria Governance: Acceptance criteria will be established based on the User Requirements Specification (URS) and must be met during the validation phases.

Calibration/PM Governance: The Manual Inspection Booth must undergo regular calibration and preventative maintenance as per the manufacturer’s recommendations and internal procedures.

Change Control Triggers: Any changes to the equipment, processes, or associated documentation must be evaluated through the change control process to assess impact on validation status.

Revalidation Triggers and Periodic Review: Revalidation is required every 12 months or when significant changes occur that may affect equipment performance.

Records/Attachments List:

• User Requirements Specification (URS)
• Validation Protocols and Reports (DQ, IQ, OQ, PQ)
• Calibration and Maintenance Records
• Change Control Documentation
• Periodic Review Reports