Standard Operating Procedure for Equipment Validation of Particle Size Classification System

Purpose

This SOP outlines the validation process for the Particle Size Classification System utilized in the R&D and Production areas for size fraction selection of microspheres and microcapsules.

Scope

This procedure applies to the Particle Size Classification System (Sieves/Air Classifier) used in the development and production of NDDS formulations. It covers all phases of the equipment lifecycle, including Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

Definitions

• NDDS: Novel Drug Delivery Systems
• DQ: Design Qualification
• IQ: Installation Qualification
• OQ: Operational Qualification
• PQ: Performance Qualification

Roles

• Validation Team: Responsible for executing the validation protocol and documenting results.
• Quality Assurance: Ensures compliance with regulatory standards and reviews validation documentation.
• Equipment Owner: Responsible for the maintenance and operation of the equipment.

Lifecycle Procedure

1. Design Qualification (DQ): Verify that the equipment design meets user requirements.
2. Installation Qualification (IQ): Confirm that the equipment is installed correctly and in accordance with manufacturer specifications.
3. Operational Qualification (OQ): Ensure that the equipment operates within specified limits under normal operating conditions.
4. Performance Qualification (PQ): Validate that the equipment performs as intended with actual product.

Good Documentation Practices (GDP) Controls

All records related to the validation process must be completed in accordance with GDP, ensuring accuracy, legibility, and traceability.

Acceptance Criteria Governance (URS)

Acceptance criteria must be defined in the User Requirement Specification (URS) and adhered to throughout the validation process.

Calibration and Preventive Maintenance Governance

The Particle Size Classification System must undergo regular calibration and preventive maintenance as per the manufacturer’s recommendations and internal procedures.

Change Control Triggers

Any changes in equipment, processes, or materials that may affect the performance or validation status of the Particle Size Classification System must initiate a change control process.

Revalidation Triggers and Periodic Review

Revalidation is required every 24 months, or sooner if significant changes occur that may impact equipment performance.

Records/Attachments List

• Validation Protocols
• User Requirement Specification (URS)
• Calibration Records
• Preventive Maintenance Logs
• Change Control Documentation
• Revalidation Reports