Standard Operating Procedure for the Validation of Rotary Sifter Equipment

Purpose: This SOP outlines the requirements and procedures for the validation of the Rotary Sifter used in the production of solid dosage forms, ensuring compliance with regulatory standards and operational effectiveness.

Scope: This SOP applies to the validation of the Rotary Sifter utilized in the sieving of powders within the production area. It encompasses the entire validation lifecycle, including Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

Definitions:

• Validation: The process of establishing documented evidence that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes.
• Rotary Sifter: Equipment used for sifting powders to ensure uniformity and removal of oversized particles.
• Criticality: Major – indicating a direct impact on product quality and safety.

Roles:

• Validation Team: Responsible for conducting and documenting validation activities.
• Quality Assurance: Ensures compliance with regulatory requirements and oversees validation processes.
• Production Personnel: Operate the equipment and provide necessary input during validation activities.

Lifecycle Procedure:

1. Conduct Design Qualification (DQ) to ensure equipment specifications meet user requirements.
2. Perform Installation Qualification (IQ) to verify installation meets manufacturer specifications.
3. Carry out Operational Qualification (OQ) to confirm equipment operates correctly under normal operating conditions.
4. Execute Performance Qualification (PQ) to ensure the equipment performs as intended in a production environment.

GDP Controls: Good Documentation Practices (GDP) must be adhered to throughout the validation process to ensure accuracy and traceability of all records.

Acceptance Criteria Governance: Acceptance criteria for the validation of the Rotary Sifter will be defined based on the User Requirements Specification (URS) to ensure that the equipment meets its intended purpose.

Calibration/PM Governance: Regular calibration and preventive maintenance (PM) schedules must be established and documented to maintain equipment performance and compliance.

Change Control Triggers: Any modifications to the Rotary Sifter or its operating procedures must initiate a change control process to assess potential impacts on validation status.

Revalidation Triggers and Periodic Review: Revalidation of the equipment is required every 24 months or in response to significant changes in process or equipment. A periodic review of validation documentation should be conducted to ensure ongoing compliance.

Records/Attachments List:

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