Medical Device and Pharmaceutical Manufacturing

Section 211.3707  Medical Device and Pharmaceutical Manufacturing "Medical Device and Pharmaceutical Manufacturing" means, for purposes of 35 Ill. Adm. Code 218.187 and 219.187, the collection of equipment and activities to prepare, utilize, maintain, and repair work areas, in order to accomplish one or more steps in preparing a medical device or pharmaceutical for its intended use.  Manufacturing is typically, but not always, conducted in accordance with criteria and procedures established to meet requirements of the United States Food and Drug Administration and/or other applicable regulatory agencies with authority over manufacturing operations for global sales of medical devices and/or pharmaceuticals.  Work areas and equipment shall include all machinery, tools, equipment, rooms, tables, countertops, and facilities for maintaining employee health and safety that are subject to such criteria and procedures.