Standard Operating Procedure for the Validation of Tablet Press Equipment in Solid Dosage Forms

Purpose: This SOP outlines the validation process for the Tablet Press (Bilayer/Multilayer) used in the production of solid dosage forms, ensuring compliance with regulatory requirements and maintaining product quality.

Scope: This procedure applies to the validation of Tablet Press equipment within the Production/Compression area for the manufacture of multilayer tablets. It encompasses Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

Definitions:

• Equipment Validation: A documented process that demonstrates that equipment operates consistently and produces the desired outcomes.
• Criticality: The importance of the equipment in ensuring product quality and compliance.
• CSV: Computerized System Validation, a process ensuring that computerized systems are fit for intended use.

Roles:

• Validation Team: Responsible for executing validation protocols and documenting results.
• Quality Assurance: Ensures compliance with regulatory standards and reviews validation documentation.
• Production Personnel: Operate the equipment and provide input during validation activities.

Lifecycle Procedure:

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

GDP Controls: Good Documentation Practices must be followed throughout the validation process, ensuring all records are accurate, complete, and traceable.

Acceptance Criteria Governance: Acceptance criteria will be based on User Requirements Specification (URS) and Annex 11 guidelines, ensuring that all critical parameters are met during validation.

Calibration/PM Governance: Equipment must be calibrated and maintained according to a defined schedule, with records kept for all calibration and preventive maintenance activities.

Change Control Triggers: Any changes to the equipment, process, or product that may impact validation status must be documented and assessed through a formal change control process.

Revalidation Triggers and Periodic Review: Revalidation is required annually or if there are significant changes to the equipment or processes. A periodic review will be conducted to assess the ongoing suitability of the equipment.

Records/Attachments List:

• Validation Protocols
• Validation Reports
• User Requirements Specification (URS)
• Calibration and Maintenance Records
• Change Control Documentation