ABSTRACT

Protocols for microbiological monitoring and control of manufacturing have been established for categories of products regulated by the U.S. Food and Drug Administration (FDA). They are designated the hazard analysis and critical control point (HACCP) protocols (1). Considerable documentation describes appropriate environmental sampling and control of manufacturing systems for drugs (2 , 3), but cosmetics are not as precisely regulated as foods and drugs. Although guidelines covering cosmetic manufacture exist (4), they do not include functional details for protocols specific to the cosmetics industry. Such details are essential because cosmetics indeed constitute the most unique group of consumer products.