With the growing number of clinical trials and new therapies entering the market, speed and flexibility are vital for market success. Achieving Good Manufacturing Practice (GMP) certification is critical to moving therapies forward; however, the complexities of navigating the regulatory landscape – the expectations of which often differ by Health Authority – can slow progress. But it doesn’t have to derail your timeframe. There are steps companies can take to ensure a smoother and accelerated timeline to regulatory approval.
White Raven, a Contract Development and Manufacturing Organization (CDMO) specializing in formulation and aseptic filling for small batch injectables, recently achieved GMP certification using one of Cytiva’s gloveless, robotic isolators in just 18 months after project kickoff. Having recently helped them accomplish this, I thought I’d share the four key steps that White Raven and Cytiva’s regulatory services team took to achieve this major milestone to help you achieve your own.
Create a roadmap
Strategic planning is the cornerstone of any successful GMP certification. A well-defined regulatory roadmap provides a clear path through the complexities of the approval process, outlining each key stage, the specific regulatory requirements of the inspecting Health Authority, and potential challenges that may arise. This roadmap should serve as a dynamic tool, documenting the necessary steps at each stage, tracking completed tasks, and proactively identifying areas for continuous improvement.
White Raven partnered closely with Cytiva’s regulatory services team to develop a meticulously detailed roadmap tailored to their certification goals. This roadmap included actions and target closure dates for the development of a comprehensive EU Annex 1 assessment, a robust contamination control strategy (CCS), aseptic process simulations, detailed airflow visualization studies, and thorough risk assessments.
Documentation
Comprehensive and meticulously maintained documentation forms the bedrock of GMP certification. Regulatory authorities rely on these detailed records to verify a company’s adherence to quality standards and best practices. The documentation serves as objective evidence of compliance, demonstrating that processes are controlled, consistent, and capable of producing safe and effective products.
White Raven embraced  Cytiva’s expertise in regulatory documentation to construct a robust Inspection Package. This package encompassed critical elements such as:
- Validation processes, demonstrating that equipment and processes consistently perform as intended.
- Cleanroom protocols, outlining the procedures and controls in place to maintain the required environmental conditions.
- Risk assessment strategies, detailing the proactive measures taken to identify, evaluate, and mitigate potential risks to product quality.
A critical aspect of this process was the proactive identification and mitigation of potential regulatory questions. For instance, White Raven, with Cytiva’s support, recognized that the horizontal airflow pattern in the Cytiva aseptic filling workcell, while unidirectional, differed from traditional filling equipment airflow designs. To address this, they engaged in open communication with their local inspectorate via pre-inspection meetings to explain the operations and Quality by Design (QbD) features of the gloveless robotic isolator in use. This transparent and collaborative approach allowed them to address a commonly asked question before it could escalate into an obstacle, demonstrating the value of proactive risk management in the certification process. Cytiva provided comprehensive documentation, including Computational Fluid Dynamics (CFD) analysis and particle dynamics calculations, demonstrating that the horizontal airflow in the aseptic filling workcell offered effective product protection comparable to traditional systems.
Do a dry run
The adage “practice makes perfect” holds true in the context of GMP certification. Mock audits, conducted prior to the actual inspection, provide invaluable preparation for teams, simulating potential questions and scenarios they may encounter. These dry runs serve to identify any remaining gaps in processes or documentation, allowing teams to refine their responses, strengthen their preparedness, and build confidence.
White Raven, recognizing the importance of thorough preparation, conducted multiple mock audits with Cytiva’s regulatory services team. These simulated inspections were meticulously designed to mirror common regulatory queries, challenging White Raven’s team to anticipate difficult questions and hone their responses.
Have your experts onsite Â
The presence of subject matter experts (SMEs) during regulatory inspections is invaluable. These experts possess a deep understanding of the intricacies of the manufacturing process, the functionality of the equipment, and the nuances of regulatory compliance. Their ability to provide real-time support, address inspectors’ concerns, and offer immediate clarification can be instrumental in ensuring a smooth and successful inspection.
During White Raven’s GMP inspection, Cytiva’s aseptic filling, microbiology and field service experts were onsite for three days, providing crucial real-time support. Having the Cytiva expertise on-site facilitated more seamless communication between White Raven and the regulators and provided clear explanations of the aseptic filling workcell’s functionality. Following the inspection, these experts continued to provide support, assisting White Raven in efficiently identifying any corrective and preventive actions.
The power of collaboration
White Raven’s journey to GMP certification exemplifies the power of collaboration, proactive planning, and their commitment to quality. By combining innovative technology, robust regulatory support, and the expertise of drug manufacturers, companies can navigate the complexities of GMP certification with greater efficiency and confidence.
Often, robust regulatory support from a vendor is not enough—expectations of inspectors are high even for the most advanced filling technology. Identifying a supplier that can continuously improve quality by design is crucial as this is an expectation of regulators. With a decade of experience manufacturing and delivering gloveless, robotic workcells for customers, Cytiva continues to collect regulatory insights from its 70+ workcells in the field and uses those insights to enhance its designs most recently integrating cutting edge environmental monitoring technologies such as biofluorescent particle counters which enable real-time viable monitoring.
In an environment of increasing regulatory scrutiny and growing complexity, the ability to achieve GMP readiness efficiently is a critical competitive advantage. The example set by White Raven with Cytiva’s support demonstrates that through thoughtful preparation, expert guidance, and a commitment to collaboration, companies can not only navigate the regulatory landscape but also accelerate their path to success.
Further, White Raven actively participates in Cytiva’s aseptic filling user group which serves as a platform to share best practices with other users of Cytiva’s standardized designs including insights from regulators. If you’re curious about Cytiva’s aseptic filling workcells and how our regulatory services can enhance your GMP journey, find out more here.
