The Pharmaceutical Trace Impurities focus group provides benefits to pharmaceutical scientists by providing a single, broad forum to discuss technical and regulatory topics associated with the impurities, especially genotoxic impurities, and to better understand at the grass-roots level practices, approaches, and trends used across the industry. The group will focus particularly on highly sensitive analytical methodology development, process development, and genotoxicity tests for impurities/genotoxic impurities that are capable of controlling these impurities.
Pharmaceutical Impurities could be classified into organic impurities (include genotoxic impurities), inorganic/metal impurities, residual solvents, leachables/extractable, excipient-related impurities. The toxicities, especially genotoxicity, of the impurities can be very dangerous to a human being. The side effects could be noticed immediately or over a period of extended use of the drug.
The control of impurities, especially potential genotoxic impurities (GTIs) in pharmaceutical products, presents significant challenges to the pharmaceutical industry due to the inherent difficulties in developing highly sensitive analytical methods, processes, and genotoxicity tests that are capable of controlling these impurities to acceptable levels. The challenges are even greater during clinical development because of aggressive timelines and the dynamic nature of chemical processes.
Regulatory agencies are increasingly concerned with low-level genotoxic impurities in drug substances, requiring manufacturers to deliver innovative approaches for their analysis and control. The need to control most impurities/genotoxic impurities to a trace level relative to the active pharmaceutical ingredient, combined with the often reactive and labile nature of genotoxic impurities, poses significant challenges to analytical, process development, and toxicology. General guidance or industry recommendation on how to develop strategies for the analysis and control of genotoxic impurities is currently lacking in the pharmaceutical industry and would be an objective of this focus group.
The Pharmaceutical Trace Impurities focus group provides an added benefit to pharmaceutical scientists by providing a single, all-encompassing forum to discuss technical and regulatory impurities/genotoxic impurities topics associated with the development of pharmaceuticals. The group will effectively communicate to establish dialogues among industry, academia, and regulatory groups to discuss technical advances and understand and apply changes in regulatory viewpoint on impurities/genotoxic impurities.
The group aims to facilitate discussion around science/risk-based regulations and regulatory review practice. The group will catalyze opportunities to expand targeted academic support and collaborations on topics involving impurities/genotoxic impurities. This focus group will provide a forum for discussion among researchers engaged in basic scientific work in analytical/process chemistry/toxicology and serve as an outlet to connect with members of other sections and focus groups with related interests in the field.
- Establish a core group of interested scientists to explore diverse areas of genotoxic impurities; discuss technical (analytical, process and toxicology) and regulatory issues pertinent to genotoxic impurities.
- Define technical and regulatory genotoxic impurities issues related to development of pharmaceuticals.
- Provide a forum to discuss genotoxic impurities scientific issues and exchange ideas/best practices.
- Organize quality programs for the annual meeting and to conduct workshops on current ICH, Food and Drug Administration (FDA), and international requirements.
- Provide an avenue for training of new guidances on impurities/genotoxic impurities topics.
- Act as a link among members of industry, academy, and regulatory.
- Facilitate workshops/symposia and share experiences and communicate key lessons learned with industry and regulators.
Section affiliations: APQ | MSE | RS