Do we truly know how to ensure IND or IMPD Quality (CMC) part is written in good quality, consistent and clear technical language? How to effectively manage the writing process? In this article, I will focus on these questions and the initial IND/IMPD, required to start clinical investigations in humans. Furthermore, I will provide the key features and practical advice on how to deliver effectiveness.
Before discussions on IND/IMPD CMC writing, let’s agree on the terminology we use:
- Investigational New Drug (IND) application is the document to be submitted to the FDA in order to obtain regulatory approval to start clinical trials in the United States.
- IMPD is a part of the Clinical Trial Application to be submitted to regulatory authorities within the European Union to receive approval to start clinical trials in a concerned Member State(s), where you are planning a clinical trial.
- CMC stands for Chemistry, Manufacturing and Control. We use this term to describe the chemical properties of a molecule or compound of the medicinal product, its manufacturing and analytical control testing. CMC is an interchangeable term to Quality.
- CMC writing is a standardized process of scientific and technical writing to develop the documentation needed to support regulatory interactions and filings for CMC.
Dedicated team for CMC writing
So, where we should start? Firstly, we have to define the team in order to understand if the organization has capabilities to do CMC writing in-house or needs to outsource these activities.
Thus, who usually do CMC writing? That very much depends on the organization. Commonly, the CMC regulatory people being the most suitable choice. In case the organization does not have such positions, CMC writing can be moved to R&D – individuals responsible for R&D documents technical writing, or Subject Matter Experts (SMEs) within an organization, or even QA/QC staff. Those people should have high-grade writing skills, ability to write clearly, accurate and meet expectations of writing style expected by agencies. Also, as a minimum, they have to have completed pieces of training for technical writing, IND/IMPD quality part structure and regulatory requirements.
CMC documents writing requires close collaboration among multiple technical teams. Therefore, once you identify the responsible side for effective IND/IMPD writing, careful planning and organization of writing activities along with agreed rules of communication is mandatory for the liable team.
Fundamentals of CMC writing process
The project manager or CMC lead usually lead the CMC writing activities. This person, besides knowledge on CMC operational activities, should have the ability to interact, cooperate and motivate team across the departments and functions. In case CMC writers are not a part of the organization, where the process is developed, i.e. CMO, or CDMO, then all process requires even more efficient project management. A well-defined IND/IMPD preparation plan should be in place and the content agreed with all stakeholders in advance: data providers, CMC writers, and reviewers. The lead should communicate document-specific timelines to all team members among organizations and ensure the achievement of wanted deliverables on time as well as to ensure confirmed CMC writers availability.
Thus, writing an IND/IMPD requires skilled and experienced people with relevant background who understand and can interpret the scientific data, know the regulatory requirements, and can identify gaps and discrepancies.
To summarize, there are several factors affecting IND and IMPD writing, but to have a dedicated and trained team for CMC is an essential, otherwise inconsistencies and lost in quality will be guaranteed. If the organization don’t have the needed capabilities or has them only partly, the decision to outsource these activities should go without saying. Besides, the preparation plan of IND/IMPD should be agreed with all the stakeholders in front to ensure clear communication and effective management.
If you want to get more information about CMC writing and outsourcing solutions, contact us!
Ramune Rukiene, MSc
Director Regulatory Affairs