The overall quality of a drug substance or pharmaceutical most often depends on the extent to which the level of impurity in it has been controlled. Unfortunately impurities, suggestive of risks, can rarely be brought down to zero, and efforts can only be made to reduce them to the lowest levels that are reasonably practical. Several international guidelines have been arrived at to aid the drug developers and regulatory agencies to evaluate and control the impurities in drug substances these methods for detecting and controlling the impurities are subject to continuous review and improvement, and the concerned departments need to keep updated by keeping a close watch on the various guidances being issued by the authorities, understanding the rationale and requirements fully.
This workshop will study the current regulatory environment in which the drug developers operate, with a special focus on genotoxic impurities arising in drug substances. Concerns of the small to mid-sized company, possible strategies that could be adopted while dealing with the regulatory authorities, development and validation of analytical methods to manage genotoxic impurities, study of the recent causes of concern vis-a-vis genotoxic impurities etc. will be examined in addition to an overview of the existing official Guidelines and protocols, reporting practices etc.
The workshop is recommended for scientists working in R&D, Regulatory Affairs, Quality Control / Quality Assurance, Toxicology, Manufacturing, Compliance, Preclinical Development etc.
Venue: AIPS, Mumbai
Date: January 23, 2010
For more details: info@aips.ac.in
