Standard Operating Procedure for the Validation of Vibro Sifter Equipment

Purpose: This SOP outlines the validation process for the Vibro Sifter used in the production of solid dosage forms, ensuring compliance with regulatory standards and product quality.

Scope: This procedure applies to the Vibro Sifter utilized in the sieving and de-lumping of powders and granules within the production area.

Definitions:

• Vibro Sifter: A piece of equipment used for sifting and de-lumping powders and granules.
• Validation: The process of ensuring that equipment operates according to its intended use.
• Criticality: Major – indicates a direct impact on product quality.

Roles:

• Validation Team: Responsible for executing and documenting the validation process.
• Quality Assurance: Ensures compliance with regulatory standards and reviews validation documentation.
• Production Personnel: Operate the Vibro Sifter and provide feedback on its performance.

Lifecycle Procedure:

1. Design Qualification (DQ): Verify equipment design meets user requirements.
2. Installation Qualification (IQ): Confirm equipment is installed correctly and according to specifications.
3. Operational Qualification (OQ): Ensure equipment operates within specified limits.
4. Performance Qualification (PQ): Validate equipment performance with actual product.

Good Documentation Practices (GDP) Controls: All documentation must be completed accurately and in real-time, ensuring traceability and compliance.

Acceptance Criteria Governance (URS): Acceptance criteria must be defined in the User Requirements Specification (URS) and adhered to throughout the validation process.

Calibration/PM Governance: The Vibro Sifter must undergo regular calibration and preventive maintenance as per the established schedule to ensure optimal performance.

Change Control Triggers: Any modifications to the equipment, processes, or operating procedures must initiate a change control process.

Revalidation Triggers and Periodic Review: Revalidation is required every 24 months or when significant changes are made to the equipment or process.

Records/Attachments List:

• Validation Protocols
• Validation Reports
• User Requirements Specification (URS)
• Calibration and Maintenance Logs
• Change Control Documentation