We at TSI Consultants understand that preparing for a real DRAP inspection or audit can be a detailed, time consuming, and stressful task. Many companies worry about potential fines, penalties, or even product recalls if they fail to comply with DRAP regulations.
That’s why we offer comprehensive mock DRAP inspection services to help you prepare for an actual DRAP inspection. Our team of experts will conduct a thorough inspection of your facility, review your documentation, and provide you with valuable feedback on areas that need improvement to ensure compliance with DRAP regulations.
Facility Inspections
We will conduct a comprehensive facility inspection to assess current Good Manufacturing Practices (cGMP) compliance, including hygiene, equipment maintenance, documentation, and quality control systems. Our experienced inspectors will identify potential deficiencies and provide guidance on corrective actions to ensure successful DRAP inspections.
Documentation Reviews
Our team will review your documentation, including labeling, batch records, procedures, and verification and validation activities. We will ensure that your documentation meets DRAP guidelines and will provide recommendations for any deficiencies.
Team Training
We offer customized training programs to help educate your employees on the latest DRAP regulations to help ensure compliance. Our training programs are designed to make sure that your staff has a comprehensive understanding of the regulations and how they apply to your business.
Report Generation
Upon completion of the comprehensive inspection, our team will provide a detailed report (similar to an DRAP) that includes observations, findings, and recommendations for improving compliance with DRAP regulations. Our report will help you identify areas for improvement and develop action plans to address noted deficiencies before a real DRAP inspection.
1. Prepare for the real audit:
Conducting a mock DRAP inspection can help a pharmaceutical manufacturer identify areas of inefficiencies, flaws, and non-compliance. The manufacturer can then take corrective action ahead of the actual DRAP inspection, ensuring they pass the official audit with flying colors.
2. Ensure continuous compliance:
A mock DRAP inspection helps pharmaceutical manufacturers maintain their compliance with DRAP regulations. It helps to identify any potential gaps in the manufacturing, documentation, or quality management systems, providing an opportunity to rectify it before the real audit.
3. Boost quality:
A mock DRAP inspection can improve the quality of pharmaceutical products. It enhances the company’s understanding of DRAP regulations and requirements, promoting a proactive approach to quality management that ensures the products meet the highest quality standards.
4. Enhance reputation:
A successful mock DRAP inspection can boost the reputation of a pharmaceutical manufacturer, demonstrating their commitment to quality and compliance with regulatory standards.
5. Save money:
Conducting a mock DRAP inspection can save pharmaceutical manufacturers significant costs associated with reworks, recalls, or penalties that may result from failed DRAP audits. It is a proactive approach that guarantees compliance and avoids serious implications for the company.
