Pharmaceutical Impurities

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The Pharmaceutical Impurities focus group benefits pharmaceutical scientists by providing a single, broad forum to discuss technical and regulatory topics associated with impurities in an effort to better understand, at the grass-roots level, practices, approaches, and trends across the industry. The group will focus on impurities at all levels for both small molecule and biologic medicines.

Pharmaceutical Impurities are classified as organic impurities (e.g., “standard”/non-alerting and genotoxic impurities), inorganic/metal impurities, residual solvents, leachables/extractables, and excipient-related impurities. The toxicities of impurities can be very dangerous to humans. The side effects could be noticed immediately or over a period of extended use of the drug. In the cases where the impurities are qualified, there is still an expectation that they are controlled to reasonably low levels to ensure the quality of the product.

Regulatory agencies are increasingly concerned with impurities, especially trace impurities such as low-level genotoxic and heavy metal impurities in drug substances, which require manufacturers to deliver innovative approaches for their analysis and control. The need to control most impurities to a trace level relative to the active pharmaceutical ingredient poses significant challenges to analytical, process development, and toxicology. Impurities that are reactive and/or labile in nature pose further challenges. 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 Impurities focus group provides an added benefit to pharmaceutical scientists by providing a single, all-encompassing forum to discuss technical and regulatory topics associated with the development of pharmaceuticals with respect to impurity control. The group will effectively communicate to establish dialogues among industry, academia, and regulatory groups to discuss technical advances and to understand and apply changes in regulatory viewpoint on 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. 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. 

  • Establish a core group of interested scientists to explore diverse areas of impurities; discuss technical (analytical, process and toxicology) and regulatory issues pertinent to impurities. 
  • Define and address technical and regulatory impurities issues related to development of pharmaceuticals for both small molecule and biological medicines. 
  • Provide a forum to discuss scientific issues relating to impurities and exchange ideas/best practices. 
  • Organize quality programs for the AAPS Annual Meeting and Exposition and conduct workshops on current International Conference on Harmonisation, Food and Drug Administration, and global requirements. 
  • Provide an avenue for training of new guidances on impurity related 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 


2017 AAPS Annual Meeting and Exposition
November 12–15, 2017
San Diego Convention Center, San Diego

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