Standard Operating Procedure for Equipment Validation of Encapsulation Coater
Purpose: This SOP outlines the validation process for the Encapsulation Coater (Wurster/Bottom Spray) used in the coating of particles for controlled release in R&D and production environments.
Scope: This procedure applies to the validation of the Encapsulation Coater within the NDDS – Microspheres & Microcapsules category, covering all aspects from Design Qualification (DQ) to Performance Qualification (PQ).
Definitions:
- DQ: Design Qualification
- IQ: Installation Qualification
- OQ: Operational Qualification
- PQ: Performance Qualification
- CSV: Computerized System Validation
Roles:
- Validation Team: Responsible for executing the validation protocol.
- Quality Assurance: Ensures compliance with regulatory standards.
- Equipment Owner: Manages the operation and maintenance of the equipment.
Lifecycle Procedure:
- Design Qualification (DQ)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
GDP Controls: Good Documentation Practices must be followed throughout the validation process to ensure traceability and compliance.
Acceptance Criteria Governance: Acceptance criteria must align with User Requirements Specification (URS) and comply with Annex 11 and Annex 15 of the relevant guidelines.
Calibration/PM Governance: The Encapsulation Coater must undergo regular calibration and preventive maintenance as per the maintenance schedule to ensure consistent performance.
Change Control Triggers: Any changes to the equipment, processes, or software must initiate a change control process to assess the impact on validation status.
Revalidation Triggers and Periodic Review: Revalidation is required every 12 months or upon significant changes to the equipment or process.
Records/Attachments List:
- Validation Protocols (DQ/IQ/OQ/PQ)
- Calibration Records
- Maintenance Logs
- Change Control Documentation
- Periodic Review Reports