Standard Operating Procedure for the Validation of Loss-in-Weight Feeders

Purpose: This SOP outlines the validation process for Loss-in-Weight Feeders used in the production of solid dosage forms to ensure accurate powder feeding.

Scope: This procedure applies to the validation of Loss-in-Weight Feeders in the Production/Continuous Manufacturing area within the pharmaceutical industry.

Definitions:

• Loss-in-Weight Feeder: A device used for accurate feeding of powders by measuring the weight loss over time.
• Validation: The process of establishing documented evidence that a system or process meets its intended requirements.
• Criticality: The importance of a piece of equipment in the manufacturing process, classified as critical, major, or minor.

Roles:

• Validation Team: Responsible for the execution and documentation of validation activities.
• Quality Assurance: Ensures compliance with regulatory requirements and internal standards.
• Production Personnel: Operate the equipment and provide input during the validation process.

Lifecycle Procedure:

1. Design Qualification (DQ): Verify that the design of the Loss-in-Weight Feeder meets user requirements.
2. Installation Qualification (IQ): Confirm that the equipment is installed correctly and according to specifications.
3. Operational Qualification (OQ): Validate that the equipment operates within specified limits under normal operating conditions.
4. Performance Qualification (PQ): Ensure that the equipment performs effectively and consistently in production.

GDP Controls: Good Documentation Practices must be adhered to throughout the validation process to ensure data integrity and traceability.

Acceptance Criteria Governance: Acceptance criteria will be defined based on User Requirements Specification (URS) in accordance with Annex 11 of the relevant guidelines.

Calibration/PM Governance: The Loss-in-Weight Feeder must be calibrated and undergo preventive maintenance as per the manufacturer’s recommendations and internal SOPs.

Change Control Triggers: Any changes to the equipment, process, or materials that may impact the validation status must be evaluated through a change control process.

Revalidation Triggers and Periodic Review: Revalidation is required every 12 months or when significant changes occur. A periodic review of the validation status should be conducted annually.

Records/Attachments List:

• Validation Protocols
• Validation Reports
• Calibration Certificates
• Change Control Documentation
• Periodic Review Records