Equipment Validation SOP for Viscometer/Rheometer in NDDS
Purpose: This SOP outlines the validation process for the Viscometer/Rheometer used in NDDS, ensuring compliance with regulatory standards and maintaining product quality.
Scope: This procedure applies to the validation of the Viscometer/Rheometer utilized in the Quality Control (QC) and Research & Development (R&D) areas for viscosity and rheology assessments critical to delivery performance.
Definitions:
- NDDS: Novel Drug Delivery Systems
- CQA: Critical Quality Attributes
- CPP: Critical Process Parameters
- DQ: Design Qualification
- IQ: Installation Qualification
- OQ: Operational Qualification
- PQ: Performance Qualification
Roles:
- Validation Team: Responsible for executing the validation process.
- QC Personnel: Conducts routine testing and ensures compliance with specifications.
- R&D Personnel: Utilizes the equipment for development and testing purposes.
- Quality Assurance: Oversees compliance and documentation.
Lifecycle Procedure:
- Design Qualification (DQ) – Review user requirements and specifications.
- Installation Qualification (IQ) – Verify installation and operational readiness.
- Operational Qualification (OQ) – Confirm that the instrument operates within specified limits.
- Performance Qualification (PQ) – Validate performance under actual operating conditions.
GDP Controls: All activities must adhere to Good Documentation Practices to ensure traceability and compliance.
Acceptance Criteria Governance: Acceptance criteria shall be defined in the User Requirement Specification (URS) and Annex 11 of the relevant guidelines.
Calibration/PM Governance: Calibration and preventive maintenance (PM) shall occur as per the manufacturer’s recommendations and documented in the maintenance log.
Change Control Triggers: Any changes to the equipment, processes, or personnel that may affect validation status must initiate a change control process.
Revalidation Triggers and Periodic Review: Revalidation is required every 12 months, or when significant changes occur that may impact equipment performance.
Records/Attachments List:
- Validation Protocols
- Calibration Certificates
- Maintenance Logs
- Change Control Records
- Revalidation Reports