Blog

June 16, 2024

How to Audit a  RABS (Restricted Access Barrier Systems) isolators for GMP

How to Audit a  RABS (Restricted Access Barrier Systems) isolators for GMP (Good Manufacturing Practices) involves thorough assessment to ensure compliance with regulatory requirements and industry standards. Here’s a structured approach you can follow:

Pre-Audit Preparation

1. Review Documentation:
   • Obtain and review relevant SOPs (Standard Operating Procedures), validation documents, maintenance records, and any previous audit reports related to the RABS isolators.
2. Regulatory Requirements:
   • Familiarize yourself with local regulatory requirements (e.g., FDA, EMA, WHO GMP guidelines) and company-specific GMP standards that apply to RABS isolators.
3. Audit Checklist:
   • Prepare a comprehensive checklist covering key aspects such as design qualification (DQ), installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), maintenance, cleaning procedures, and training records.

On-Site Audit

1. Physical Inspection:
   • Verify the physical condition of the RABS isolators including cleanliness, integrity of barriers, seals, and filters.
   • Ensure that the isolator setup meets design specifications and complies with GMP requirements for preventing contamination.
2. Operational Checks:
   • Observe the operation of the isolators during routine production or simulated conditions.
   • Check the functionality of control systems, pressure differentials, airflow patterns, and alarm systems.
3. Documentation Review:
   • Examine records of maintenance activities, calibration of instruments, and periodic validation reports.
   • Confirm that cleaning procedures are documented, validated, and followed rigorously.
4. Training and Competency:
   • Review training records to ensure that personnel operating the RABS isolators are adequately trained and understand their responsibilities.
   • Assess the competency of operators in responding to deviations and emergencies.
5. Risk Assessment:
   • Evaluate risk assessments related to the RABS isolators, including identification of critical control points and mitigation strategies.
6. Data Integrity:
   • Verify data integrity practices, particularly concerning data generated by the isolators and any associated control systems.

Post-Audit Actions

1. Audit Report:
   • Compile findings into a structured audit report, clearly identifying any non-conformities or areas of improvement.
2. Corrective and Preventive Actions (CAPA):
   • Work with the auditee to develop CAPAs for any identified non-conformities.
   • Ensure that CAPAs address root causes and include timelines for implementation and verification.
3. Follow-Up:
   • Conduct follow-up audits as necessary to verify the implementation and effectiveness of CAPAs.
4. Continuous Improvement:
   • Encourage a culture of continuous improvement in RABS isolator operations and maintenance.

Key Considerations

• Compliance: Ensure that the RABS isolators comply not only with GMP standards but also with specific requirements for your industry and region.
• Validation: Validate any changes made to the RABS isolators or associated processes to maintain compliance.
• Training: Ongoing training and awareness are critical to sustaining GMP compliance.

By following this structured approach, you can effectively audit RABS isolators for GMP, ensuring they meet regulatory requirements and contribute to product quality and s