Pharmaceutical companies develop clinical trials of new drugs using two separate and distinct teams. The design and development team is responsible for designing and developing the trial, ensuring that the process to bring a drug to trial remains on-task and cost effective. The Chemistry and Manufacturing Controls (CMC) team oversees development of the drug. This includes preparation of all regulatory documentation and communication within and outside of the organisation.
Standards and Regulations
The CMC team must understand government regulations and industry standards related to product development. Different regulations exist within the industry and depend on how the drug will be used. Standards and regulations change over time, and the CMC team must remain up-to-date with current policies and the impact they have on drugs currently in development.
The CMC team is responsible for creating clear, understandable documentation in support of the new drug, including safety, efficacy and consistency. Reports outline chemical information about the drug, manufacturing details and information about the clinical trial. The team submits documentation in a timely fashion to the U.S. Food and Drug Administration. Documents must be complete, timely, accurate and comply with government regulations. The team is also responsible for implementing version control to documents. Documentation within the organisation includes reports and product approval strategies, and changes to documentation for products already on the market.
The CMC team must adhere to strict current Good Manufacturing Practice (cGMP) guidelines during manufacturing, and continue to follow standard practice throughout packaging and testing phases. This includes documenting activities involved in these processes so that an accessible paper trail is created. An acceptable procedure of checks and balances must be in place throughout the process to prevent an unacceptable drug from reaching a clinical trial. The CMC team must undergo periodic audits to make sure supplies and processes are acceptable.
The CMC team represents the drug development aspect to other departments within the organisation, and fosters communication with government and other entities. The team communicates regulations and standards to the drug development team, and department strategies and changes in regulations to the organisation and senior management.
The CMC team works with company management to develop and approve a budget at the beginning of any project. In this way, all parties quickly understand the expenses involved in this aspect of a clinical trial and are able to mitigate risks throughout the project. Tasks to be performed by the team must be assigned a realistic assessment of the time and expense that will be required.