Elevating Standards at Southern RNA: Embracing Quality Risk Management
Assessment, control, communication, and review of quality risks.
At Southern RNA, we're committed not only to innovation but also to excellence in every aspect of our operations. As part of this ongoing commitment, our team recently had the privilege of participating in a training workshop led by Antiksha Joshi (Urmi Quality Management Consulting). The focus? Quality Risk Management (QRM) as defined by ICH Q9 (R1) Quality Risk Management Guideline – a critical pillar in the manufacturing of clinical-grade mRNA products.
Why is QRM pivotal for us at Southern RNA?
In the rapidly evolving field of mRNA therapeutics, the stakes are high. The production of clinical-grade mRNA necessitates not just precision but also an unwavering dedication to quality and safety. QRM enables us to proactively identify, evaluate, and mitigate risks throughout our manufacturing processes. It's about ensuring the highest standards of product purity, efficacy, and safety – the cornerstones of patient trust and regulatory compliance.
This training session with Antiksha Joshi is a testament to our dedication to fostering a culture that prioritises GMP (Good Manufacturing Practice) compliance. It reflects our holistic approach to quality management, integrating robust QRM principles into our daily operations to not only meet but exceed the stringent requirements of mRNA product manufacturing.
Leveraging expertise to establish compliant and phase appropriate quality systems
As Southern RNA continues to grow, our embrace of QRM is more than a regulatory necessity; it's a reflection of our commitment to excellence and to the health and safety of the communities we serve. We're proud to develop a culture and processes that are not just GMP-compliant but also aligned with the best practices in our industry.
A huge thank you to Antiksha Joshi for her invaluable insights and to our team for their active participation and dedication to excellence. Together, we continue to elevate our practices and offer industry-standard manufacturing services in the field of mRNA therapeutics, driven by a shared vision of delivering transformative solutions.
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