ABSTRACT
I. INTRODUCTION The focus for this chapter is on a basket of environmental issues important to a bulk drug manufacturing facility staying in compliance with its environmental regulations and understanding its expectations from the emerging global framework called sustainability. The first group of issues discussed can be thought of as management tools serving as a type of scaffolding supporting the facility’s compliance efforts. The issues associated with management tools are license to operate, management systems, environmental scoping, project schedules, environmental profiles, and environmental dossier. The second group of issues is directly related to environmental compliance and is associated with applicable regulatory requirements, control equipment plans, operational flexibility, and management of change. Finally, the last group of issues addresses the emerging topics of sustainability and green chemistry initiatives within the pharmaceutical industry. The topic treatment is overview in nature but hopefully gives enough to the inexperienced and veteran practitioners for them to utilize the references for more depth and follow-up.
