GMPs for OTC and Cosmetic Products - US and Global Requirements 2016

Key Topics

• FDA Guidance Documents for OTC`s and Cosmetics
• Can OTC medicines be marketed without pre-approval from FDA?
• FDA`s review of OTC drugs is primarily handled by CDER`s Office of Drug Evaluation IV
• OTC Drug Products for existing Monographs
• CGMP regulations for OTC products contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product
• FDA ensures the quality of drug products by carefully monitoring drug manufacturers` compliance with its Current Good Manufacturing Practice (CGMP) regulations
• Good manufacturing practice (GMP) is an important factor in helping to assure that your cosmetic and OTC products are neither adulterated nor misbranded
• What are the requirements for manufacturing OTC drug products and cosmetics?

Who should Attend

Attendees from personal care, cosmetic, chemical application and pharmaceutical industries involved in:

• Technology, Formulation and Product Development
• Research & Development
• Regulatory Affairs
• Marketing & Technical Sales
• QA / QC
• Manufacturing