Standard Operating Procedure for the Validation of Centrifugal Sifter in Solid Dosage Form

Purpose

This SOP outlines the procedures for validating the Centrifugal Sifter used in the production of Solid Dosage Forms to ensure compliance with regulatory standards and operational efficiency.

Scope

This procedure applies to the validation of the Centrifugal Sifter located in the Production/Sieving area, utilized for high-throughput sifting of solid dosage forms.

Definitions

• Validation: The process of establishing documented evidence that a system or equipment operates consistently within established parameters.
• Centrifugal Sifter: A machine used to separate particles based on their size and density through centrifugal force.
• URS: User Requirements Specification, detailing the requirements and expectations for the equipment.

Roles

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

Lifecycle Procedure

1. Design Qualification (DQ): Verify that the design meets the URS.
2. Installation Qualification (IQ): Confirm that the equipment is installed according to specifications.
3. Operational Qualification (OQ): Test the equipment under operational conditions to ensure it functions as intended.
4. Performance Qualification (PQ): Validate the equipment’s performance with actual product to ensure it meets quality standards.

GDP Controls

Good Documentation Practices (GDP) must be followed throughout the validation process, ensuring all records are accurate, complete, and traceable.

Acceptance Criteria Governance

Acceptance criteria will be derived from the URS, ensuring that all specified requirements are met during the validation phases.

Calibration/PM Governance

The Centrifugal Sifter will undergo routine calibration and preventive maintenance according to the manufacturer’s guidelines and internal SOPs to ensure consistent performance.

Change Control Triggers

Any changes to the equipment, processes, or operating conditions must be evaluated for impact on validation status and require a formal change control process.

Revalidation Triggers and Periodic Review

Revalidation is required every 24 months or upon significant changes to the equipment or process. A periodic review will assess the ongoing suitability of the equipment.

Records/Attachments List

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