Zdrowie i gospodarka · 25.10.2001
Request for Participants at the Process Analytical Technologies Subcommittee of the Advisory Committee for Pharmaceutical Science
The Food and Drug Administration (FDA) is requesting names of qualified persons to participate on the Process Analytical Technologies Subcommittee (the Subcommittee) of the Advisory Committee for Pharmaceutical Science. The Subcommittee will identify and report to the Advisory Committee for Pharmaceutical Science on scientific issues related to application and validation of online process technologies such as near infrared and Raman spectroscopy and imaging methods for application in the manufacture of drug substances and drug products. The Subcommittee will also report on the potential benefits and risks associated with the application of these new technologies to public health and, as part of this analysis, evaluate the feasibility of the parametric release concept. FDA has a special interest in ensuring that women, minority groups, and individuals with disabilities are adequately represented and, therefore encourages recommendations of qualified candidates from these groups. Final selections from among qualified candidates will be based on the expertise demonstrated and previous experience with online process technologies.