Inspection readiness and mock inspection for a CDMO

Background

The client specialises in providing end-to-end solutions for the development and production of advanced therapy medicinal products (ATMPs).Their primary business objective is to support the industry inbringing innovative therapies to market by offering expertise in process development, GMP manufacturing, and regulatory compliance for ATMPs, including viral vectors and other complex biologics. By serving as a strategic partner, they are accelerating the development of life-saving therapies.

Challenge

The challenge this company faced was securing a manufacturing licence to enable its new CDMO site, which was under construction from the ground up following initial investment, to provide ATMP development and manufacturing services.To pass inspection and secure a licence, the client required a robust, pragmatic Quality Management System, with training and supplier audits conducted. To do this, we needed to integrate with existing systems and day-to-day operations, ensuring no delay to key milestones for the wider business. Alongside this primary challenge, the overall project timeline needed to be updated with accurate milestones and new timelines, which were ultimately reported back to key stakeholders and investors.

Solution

The solution RRxCo implemented required several key components to be supported. The primary objective was to establish the Regulatory Readiness plan and execute actions aligned with business milestones. This included identifying action owners, reviewing and agreeing on realistic timelines, and providing project management oversight to ensure objectives were met. Training was also required as part of the Regulatory Readiness plan; the deliverable was to raise internal staff’s awareness of the regulations and best practices. Another objective identified in the plan was that the Supplier Assurance system was not robust and required enhancement. Specifically, supplier audits for analytical testing laboratories were needed to ensure the CDMO’s services were qualified. In summary, this supported the CDMO in successfully acquiring a manufacturing licence, enabling the organisation to start delivering customer programs and generating commercial revenue for the business.

Securing your licence

1. Establishing Goals
   From new to established sites, we start by understanding where the business is and what it is looking to achieve from our services.
2. Identifying Challenges
   Relevant assessments are conducted to identify challenges that could prevent the business from securing its licence.
3. Planning Stage
   Once assessments are complete, a plan is developed outlining how challenges will be addressed, including timelines and key milestones.
4. Providing Solutions
   The plan is put into action, which can include updating documentation and processes, conducting external audits, or delivering internal training.
5. Ensuring Excellence
   Once solutions are implemented, the business is positioned to pass a regulatory inspection, enabling delivery of customer programmes and generation of revenue.

If you are facing a challenge and would like to speak to one of our specialists, contact us at info@rrxco.com or +44 (0)1256 961 200.