Equipment Validation Procedure for Tablet Compression Machines

Purpose: This SOP outlines the validation process for the Tablet Compression Machine used in the production of solid dosage forms, ensuring compliance with industry standards and regulatory requirements.

Scope: This procedure applies to the validation of Tablet Compression Machines utilized in the Production/Compression area for tablet compression processes.

Definitions:

• DQ: Design Qualification
• IQ: Installation Qualification
• OQ: Operational Qualification
• PQ: Performance Qualification
• CSV: Computerized System Validation

Roles:

• Validation Team: Responsible for the execution and documentation of the validation process.
• Quality Assurance: Ensures compliance with regulatory requirements and reviews validation documents.
• Production Personnel: Operate the equipment and provide input on operational aspects during validation.

Lifecycle Procedure:

1. Conduct Design Qualification (DQ) to ensure the equipment meets user requirements.
2. Perform Installation Qualification (IQ) to verify the equipment is installed correctly.
3. Execute Operational Qualification (OQ) to confirm the equipment operates within specified limits.
4. Complete Performance Qualification (PQ) to demonstrate the equipment consistently produces quality products.

GDP Controls: Ensure Good Documentation Practices are followed throughout the validation process, including proper record-keeping, version control, and document approval workflows.

Acceptance Criteria Governance: Acceptance criteria shall be established based on the User Requirements Specification (URS) and Annex 11 guidelines. All criteria must be met before equipment is deemed validated.

Calibration/PM Governance: The Tablet Compression Machine shall undergo regular calibration and preventive maintenance as per the manufacturer’s recommendations and internal policies to ensure ongoing compliance and performance.

Change Control Triggers: Any change in equipment, process, or product that may impact the validation status must initiate a change control process and may require revalidation.

Revalidation Triggers and Periodic Review: Revalidation is required every 12 months or whenever significant changes occur. A periodic review of the validation status should be conducted to ensure continued compliance.

Records/Attachments List:

• Validation Plan
• Validation Protocols (DQ/IQ/OQ/PQ)
• Calibration Certificates
• Maintenance Records
• Change Control Documentation
• Periodic Review Reports