Have you ever found yourself in a meeting where Regulatory Affairs (RA) and Quality Assurance (QA) colleagues seem to be speaking entirely different languages? It’s a common scenario: RA requires a QP declaration, while QA insists it should be prepared by regulatory and vendor assurance and sent to the QP for signature. Meanwhile, vendor assurance is providing API site details and the last API GMP inspection/audit dates, Regulatory is emphasising that all registered API manufacturers on the license should be included in the declaration, not just the routine ones. If there are any issues with the GMP status of manufacturers or if they are not in use, it’s crucial to highlight and consider their removal from the license.
Additionally, RA may request comparative batch data, but it’s essential to clarify to QA colleagues that this entails obtaining COAs of batches manufactured before and after the change. Moreover, while RA may suffice with fewer validation batches for submission, QA mandates at least three batches for GMP compliance.
The crux of the matter is the disparity in language and understanding when RA intersects with QA. There’s a fine line between Regulatory and GMP requirements, often resulting in blurred responsibilities and conflicts between the two groups.
The solution? It lies in fostering a deep understanding of the quality remit. When both RA and QA are clear about their responsibilities and accountabilities, projects can progress smoothly.
At Assure Regulatory, we understand the importance of delineating this fine line, ensuring that both parties are aligned and focused on achieving project success. Let us help you transform this delicate line into a solid foundation for progress.
If you’re grappling with similar challenges, let’s work together to bridge the gap between RA and QA, empowering your projects to move forward seamlessly.