The Chemistry, Manufacturing, and Controls (CMC) focus group provides an added benefit to pharmaceutical scientists by providing a single, all encompassing forum to discuss technical and regulatory CMC topics associated with the development of pharmaceuticals. Over the past few years, there has been a lot of emphasis on modernizing the pharmaceutical industry. The ICH, Food and Drug Administration, and European Medicines Agency initiatives pertaining to Quality by Design, risk-based good manufacturing practices, etc., have paved the way for the use of risk-based concepts during the development of pharmaceuticals. Besides typical CMC challenges, the concept of real-time release has added additional technical and regulatory challenges to the industry. Therefore, there is an increased need to discuss and share technical and regulatory experiences between the various cross functional groups to ease the implementation of these concepts in the industry. Ideally, we are striving for discussions, an understanding, and solutions to several issues relating to CMC that are pertinent to the development of pharmaceuticals, biopharmaceuticals, and vaccines.
- Discuss technical (analytical, formulation, manufacturing), regulatory, and biopharm issues pertinent to the development of pharmaceuticals, biopharmaceuticals and vaccines.
- Define and identify hot-button technical and regulatory CMC issues as they are pertinent to the development of pharmaceuticals, biopharmaceuticals, and vaccines.
- Establish subgroups for executing aspects of the research plan.
- Examine results, establish the group to write a manuscript based on results, and discuss follow-up studies.
- Facilitate workshops/symposia and share experiences and communicate key lessons learned with industry and regulators.
Membership of this group includes technical and regulatory experts from various development areas such as small molecules, biotech products, medical devices, consumer health care, etc. We also anticipate active participation from agency members in this focus group.
Section affiliations: APQ | MSE | RS