Standard Operating Procedure for Equipment Validation of Spray Dryer in Inhaled NDDS

Purpose: To establish a standardized approach for the validation of the Spray Dryer used in the production of engineered inhalation particles, ensuring compliance with regulatory requirements and quality standards.

Scope: This SOP applies to the validation of the Spray Dryer equipment utilized in the R&D and Production areas for the development of inhaled NDDS powders.

Definitions:

• Equipment Validation: A documented process that demonstrates that equipment operates as intended and meets predetermined specifications.
• Critical Equipment: Equipment whose failure could result in non-compliance with regulatory standards or product quality issues.
• DQ/IQ/OQ/PQ: Design Qualification, Installation Qualification, Operational Qualification, and Performance Qualification.

Roles:

• Validation Team: Responsible for the execution and documentation of the validation process.
• Quality Assurance: Ensures compliance with regulatory requirements and reviews validation documentation.
• Maintenance Team: Conducts routine maintenance and calibration of the equipment.

Lifecycle Procedure:

1. Preparation of User Requirement Specification (URS).
2. Completion of Design Qualification (DQ).
3. Installation Qualification (IQ) to verify that the equipment is installed correctly.
4. Operational Qualification (OQ) to confirm that the equipment operates within specified limits.
5. Performance Qualification (PQ) to ensure the equipment meets operational performance criteria.
6. Documentation of all validation activities and results.

Good Documentation Practices (GDP) Controls:

• All records must be legible, signed, and dated.
• Changes to documents must be tracked and approved.
• Records must be retained as per company policy and regulatory requirements.

Acceptance Criteria Governance: Compliance with URS, Annex 11, and Annex 15 must be demonstrated through validation activities.

Calibration/PM Governance:

• Calibration of the Spray Dryer must be performed annually.
• Preventive maintenance (PM) must be documented and executed according to the manufacturer’s recommendations.

Change Control Triggers:

• Changes to equipment design or operation.
• Changes in regulatory requirements.
• Any modifications that may impact product quality or compliance.

Revalidation Triggers and Periodic Review:

• Revalidation is required every 12 months.
• Periodic review of validation status following any significant changes to processes or equipment.

Records/Attachments List:

• User Requirement Specification (URS)
• Validation Protocols and Reports (DQ/IQ/OQ/PQ)
• Calibration Certificates
• Maintenance Logs
• Change Control Documentation