INTRODUCTION

The raw materials, pharmaceutical ingredients, and active ingredients used in the manufacture of nutritional and dietary articles may range from chemically synthesized vitamins to plant extracts and animal byproducts, and these ingredients are typically not sterile. Considerable experience has accrued with these highly refined plant- and animal-derived pharmaceutical ingredients, such as microcrystalline cellulose, modified starch, lactose, and magnesium stearate, and their microbiological attributes are well established. Botanicals may be microbiologically contaminated at any point during cultivation, harvesting, processing, packing, and distribution. Major sources of microbial contamination are associated with human or animal feces used as plant manure; contaminated irrigation water and/or process water; and poor worker hygiene and sanitation practices during harvesting, sorting, processing, packaging, and transportation. Furthermore, it is essential that microbiological contamination be minimized during the manufacture of nonsterile dietary supplements. To achieve this, Good Manufacturing Practices are employed and adequate microbiological specifications are established.