Purpose

The purpose of this SOP is to outline the process for validating the Cartoning Machine used in the packaging of solid dosage forms to ensure compliance with regulatory requirements and quality standards.

Scope

This SOP applies to the validation of the Cartoning Machine located in the Packaging/Secondary area, used for carton packing of solid dosage forms.

Definitions

• Validation: The process of establishing documented evidence that a system or equipment operates as intended.
• Cartoning Machine: Equipment used for the automated packing of solid dosage forms into cartons.
• CSV: Computerized System Validation.

Roles

• Validation Team: Responsible for executing and documenting validation activities.
• Quality Assurance: Ensures compliance with validation protocols and regulatory requirements.
• Maintenance Team: Responsible for equipment maintenance and calibration.

Lifecycle Procedure

1. Conduct Design Qualification (DQ) to confirm user requirements.
2. Perform Installation Qualification (IQ) to verify equipment installation.
3. Execute Operational Qualification (OQ) to ensure the equipment operates within specified limits.
4. Carry out Performance Qualification (PQ) to validate equipment performance with actual product.

GDP Controls

Good Documentation Practices (GDP) must be followed throughout the validation process, ensuring all records are accurate, complete, and legible.

Acceptance Criteria Governance

Acceptance criteria will be defined based on User Requirements Specifications (URS) and Annex 11 of the relevant guidelines.

Calibration/PM Governance

Calibration and preventive maintenance (PM) must be performed annually, with records maintained to ensure compliance and traceability.

Change Control Triggers

Any changes to the Cartoning Machine or its operating environment must trigger a change control process, including re-evaluation of validation status.

Revalidation Triggers and Periodic Review

Revalidation is required every 12 months, or sooner if significant changes occur. A periodic review will be conducted to assess the validation status and compliance.

Records/Attachments List

• Validation Protocols
• Validation Reports
• Calibration Certificates
• Change Control Documentation
• Periodic Review Reports