Standard Operating Procedure for Equipment Validation of Dust Extraction Unit in Solid Dosage Form

Purpose: This SOP outlines the validation process for the Dust Extraction Unit (LEV) used in Solid Dosage Form production to ensure compliance with regulatory requirements and maintain product quality.

Scope: This procedure applies to the Dust Extraction Unit utilized in the Production/Containment area for dust capture, ensuring operator and product protection.

Definitions:

• DQ: Design Qualification
• IQ: Installation Qualification
• OQ: Operational Qualification
• PQ: Performance Qualification
• URS: User Requirements Specification

Roles:

• Validation Team: Responsible for executing the validation protocol.
• Quality Assurance: Ensures compliance with company policies and regulatory standards.
• Production Personnel: Operate the equipment and provide feedback on performance.

Lifecycle Procedure:

1. Design Qualification (DQ): Document user requirements and ensure equipment design meets these requirements.
2. Installation Qualification (IQ): Verify that the equipment is installed correctly and according to specifications.
3. Operational Qualification (OQ): Confirm that the equipment operates within specified limits under simulated conditions.
4. Performance Qualification (PQ): Validate the equipment’s performance in actual production conditions.

Good Documentation Practices (GDP) Controls:

• All records must be completed in real-time and signed by the responsible personnel.
• Use approved templates and formats for documentation.

Acceptance Criteria Governance (URS):

• Equipment must meet user requirements as documented in the URS.
• Performance must be validated against predetermined acceptance criteria.

Calibration/PM Governance:

• Regular calibration must be performed according to the manufacturer’s specifications.
• Preventive maintenance must occur as per the established schedule to ensure optimal performance.

Change Control Triggers:

• Any changes to the equipment or its usage must be documented and assessed for impact on validation status.
• Changes in operating procedures or material specifications require a re-evaluation of validation.

Revalidation Triggers and Periodic Review:

• Revalidation is required every 24 months or when significant changes occur.
• Periodic reviews must assess the ongoing compliance and performance of the equipment.

Records/Attachments List:

• Validation Protocols and Reports
• Calibration Certificates
• Maintenance Logs
• User Requirements Specification (URS)