Standard Operating Procedure for the Validation of Tablet Metal Detector in Solid Dosage Form

Purpose: To establish a standardized process for the validation of the Tablet Metal Detector used in the detection of metal contamination in solid dosage forms.

Scope: This SOP applies to the validation of the Tablet Metal Detector located in the Production/Compression area, ensuring compliance with regulatory requirements and product quality standards.

Definitions:

• Validation: The process of establishing documented evidence that a system or equipment operates consistently and reliably within predetermined specifications.
• Criticality: A designation indicating the potential impact of equipment failure on product quality and patient safety.
• CSV: Computerized System Validation, ensuring that computerized systems are validated for their intended use.

Roles:

• Validation Team: Responsible for executing validation protocols and documenting results.
• Quality Assurance: Ensures compliance with SOPs and regulatory standards.
• Maintenance Personnel: Responsible for routine maintenance and calibration of the equipment.

Lifecycle Procedure:

1. Design Qualification (DQ): Establish user requirements and specifications.
2. Installation Qualification (IQ): Verify that the equipment is installed correctly and meets specifications.
3. Operational Qualification (OQ): Confirm that the equipment operates according to its intended use within specified limits.
4. Performance Qualification (PQ): Validate the equipment’s performance in real-world conditions.

Good Documentation Practices (GDP) Controls:

• All validation documentation must be completed in real-time and signed by responsible personnel.
• Records should be stored securely and be easily retrievable for audits and inspections.

Acceptance Criteria Governance:

• Acceptance criteria must align with User Requirements Specification (URS) and Annex 11 of the relevant regulations.
• Any deviations from acceptance criteria must be documented and justified.

Calibration and Preventive Maintenance Governance:

• Calibration of the Tablet Metal Detector must be performed at defined intervals as per manufacturer’s recommendations.
• Preventive maintenance schedules should be documented and adhered to, ensuring optimal performance.

Change Control Triggers:

• Any changes to the equipment, software, or operating procedures must initiate a change control process.
• Changes that may impact validation status require re-evaluation of validation documentation.

Revalidation Triggers and Periodic Review:

• Revalidation is required every 12 months or following significant changes to processes or equipment.
• Periodic reviews should assess the ongoing suitability and performance of the equipment.

Records/Attachments List:

• Validation Protocols and Reports
• Calibration Certificates
• Preventive Maintenance Logs
• Change Control Records
• Periodic Review Documentation