Important elements in evaluating contract manufacturing organizations in the handling of 'potent' active pharmaceutical ingredients and products

摘要

It is a universal truth that research,development manufacture and formulation of potent active pharmaceutical ingredients(APIs)and products requires both "hardware"(facilities,equipment and engineering controls)and "software"(programs,practices and procedures)to adequately protect personnel and the environment.When employing third party contracting organizations,there is a need to evaluate safe processing with the same rigor as other aspects of drug development,such as quality assurance.