Explain the regulatory/technical reasons for developing this chapter. Describe the content of the chapter based in ICH Q3A/B. Provide examples of different levels of implementation and guidelines for use for regulatory alignment. Expected implementation timeline.
Who should participate:
Users of chemically synthesized DS and/or DP Monographs, Analytical Chemists, Laboratory managers QA/QC staff/managers, Managers, Directors, Production Managers, Compliance managers, Compendial affairs personnel, All pharmaceutical professionals/academicians interested in organic impurities in DS and Drug Products