Standard Operating Procedure for Equipment Validation of Capsule Polishers

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

Scope: This procedure applies to all Capsule Polishers utilized in the Production area for the polishing and dedusting of capsules. It encompasses the entire validation lifecycle including Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

Definitions:

• Equipment Validation: A documented process that demonstrates a system consistently produces a result meeting predetermined specifications.
• Criticality: Major – Indicates significant impact on product quality.
• Product Impact: Direct – The equipment has a direct effect on the product quality.

Roles:

• Validation Team: Responsible for the execution of validation activities and documentation.
• Quality Assurance: Ensures compliance with regulatory requirements and reviews validation documentation.
• Production Staff: Operate the Capsule Polisher and provide feedback on equipment performance.

Lifecycle Procedure:

1. Design Qualification (DQ): Review user requirements specification (URS) and confirm design meets operational needs.
2. Installation Qualification (IQ): Verify that the equipment is installed correctly and according to manufacturer specifications.
3. Operational Qualification (OQ): Test the equipment under normal operating conditions to ensure it performs as intended.
4. Performance Qualification (PQ): Validate the equipment’s performance with actual production materials to ensure it meets product specifications.

GDP Controls: Good Documentation Practices (GDP) must be adhered to throughout the validation process, ensuring all documents are complete, accurate, and traceable.

Acceptance Criteria Governance: Acceptance criteria will be established based on the URS and must be met during OQ and PQ to confirm equipment functionality and reliability.

Calibration/PM Governance: Regular calibration and preventive maintenance must be scheduled and documented to ensure ongoing compliance and performance of the Capsule Polisher.

Change Control Triggers: Any modification to the Capsule Polisher, including software updates or hardware changes, will require a change control process to be initiated.

Revalidation Triggers and Periodic Review: Revalidation is required every 24 months or when significant changes occur that may affect equipment performance or product quality.

Records/Attachments List:

• User Requirements Specification (URS)
• Validation Protocols and Reports (DQ, IQ, OQ, PQ)
• Calibration and Maintenance Records
• Change Control Documentation
• Training Records for Production Staff