Standard Operating Procedure for Equipment Validation of Blister Packing Machine

Purpose: This SOP outlines the validation process for the Blister Packing Machine used in the packaging of solid dosage forms, ensuring compliance with regulatory requirements and quality standards.

Scope: This procedure applies to the validation of the Blister Packing Machine (Thermoform) located in the Packaging/Primary area, utilized for blister packing of tablets and capsules.

Definitions:

• Validation: The process of establishing documented evidence that a procedure, process, or activity will consistently lead to the expected results.
• Blister Packing Machine: Equipment used to package tablets and capsules in blister packs.
• Criticality: Indicates the importance of the equipment in relation to product quality.

Roles:

• Validation Team: Responsible for executing the validation activities.
• Quality Assurance: Ensures compliance with regulatory standards and reviews validation documentation.
• Operations: Operates the equipment and provides feedback on performance.

Lifecycle Procedure:

1. Design Qualification (DQ): Assess design specifications against user requirements.
2. Installation Qualification (IQ): Verify that the equipment is installed correctly and meets operational requirements.
3. Operational Qualification (OQ): Test the equipment under normal operating conditions to ensure it functions as intended.
4. Performance Qualification (PQ): Validate the equipment’s performance with actual product to ensure it meets quality standards.

GDP Controls: Good Distribution Practices must be followed to ensure that the equipment is maintained, calibrated, and operated in a manner that guarantees product quality.

Acceptance Criteria Governance: Acceptance criteria must be defined in the User Requirements Specification (URS) and adhere to Annex 11 guidelines.

Calibration/PM Governance: The Blister Packing Machine must undergo regular calibration and preventive maintenance as per the established schedule to ensure ongoing compliance and performance.

Change Control Triggers: Any modifications to the equipment, processes, or materials that may impact the validation status must initiate a change control process.

Revalidation Triggers and Periodic Review: Revalidation is required every 12 months or if there are significant changes to the process, equipment, or product.

Records/Attachments List:

• Validation Protocols
• Validation Reports
• Calibration Certificates
• Change Control Records
• Maintenance Logs