At TM RA Consultancy, our dedicated auditors are unwavering in their commitment to ensuring compliance with the Good Manufacturing Practices (GMP) specifically designed for Active Pharmaceutical Ingredients (APIs). Our services guarantee that your pharmaceutical operations maintain the highest quality and regulatory compliance that Anvisa requires.
Our services include:
- Audit at API Manufacturing Sites: We conduct rigorous audits at API manufacturing sites, where the audit scope covers a comprehensive assessment of the company’s Quality Management System and the documentation related to the API of interest. Our on-site audits strictly adhere to the principles outlined in the ICH Q7 guideline.
- Issuance of Audit Report: Following the audit, we provide a detailed and transparent report outlining our findings, assessments, and recommendations. This report serves as a valuable resource for further enhancing your quality management and regulatory compliance.
- Evaluation of CAPAs: If applicable, we assist in evaluating Corrective and Preventive Actions (CAPAs) related to the audit findings. We aim to ensure that any identified issues are effectively addressed, rectified, and prevented from recurring.
With TM RA Consultancy, you can rely on our Quality Assurance services to uphold the highest standards of quality and regulatory compliance in your pharmaceutical operations. Our comprehensive approach, adherence to industry guidelines, and meticulous assessments ensure that your operations always comply with the latest regulatory standards.
