Standard Operating Procedure for Equipment Validation of High Shear Granulator

Purpose: This SOP outlines the validation process for the High Shear Granulator (HSG) used in the wet granulation of solid dosage forms, ensuring compliance with regulatory requirements and product quality standards.

Scope: This procedure applies to the validation of the High Shear Granulator within the Production/Granulation area for all products manufactured using this equipment.

Definitions:

• HSG: High Shear Granulator
• Validation: The process of establishing documented evidence that a system operates according to its intended use.
• DQ: Design Qualification
• IQ: Installation Qualification
• OQ: Operational Qualification
• PQ: Performance Qualification

Roles:

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

Lifecycle Procedure:

1. Design Qualification (DQ): Document the specifications and requirements for the HSG.
2. Installation Qualification (IQ): Verify that the HSG is installed according to manufacturer specifications.
3. Operational Qualification (OQ): Test the HSG under normal operating conditions to ensure it operates as intended.
4. Performance Qualification (PQ): Validate the HSG’s performance with actual product to ensure it meets quality standards.

GDP Controls: Good Documentation Practices must be followed throughout the validation process to ensure traceability and compliance.

Acceptance Criteria Governance: Acceptance criteria will be established based on the User Requirements Specification (URS) and Annex 11 of the relevant guidelines.

Calibration/PM Governance: The HSG must undergo regular calibration and preventive maintenance as per the manufacturer’s recommendations and company policies.

Change Control Triggers: Any changes to the HSG, including modifications to hardware or software, must initiate a change control process.

Revalidation Triggers and Periodic Review: Revalidation of the HSG is required every 24 months or upon significant changes to the equipment or process.

Records/Attachments List:

• Validation Protocols
• Validation Reports
• Calibration Certificates
• Preventive Maintenance Records
• Change Control Documentation