ABSTRACT

INTRODUCTION Pharmaceutical manufacturing facilities are required to comply with numerous occupational safety and health regulations, codes, guidelines, and best management practices. Therefore, occupational health and safety management and compliance are important concepts that must be addressed during the design of the facility. Occupational health and safety pertains to all personnel who perform work at pharmaceutical finishing facilities: it covers both company and contract employees working during routine, non-routine, and construction activities. It addresses the chemical, physical, and biological hazards that may be handled and or processed at the facility. It does not address the safety of the products, which are addressed through current Good Manufacturing Practices (cGMPs).