INTRODUCTION

Good manufacturing practices require that objectionable organisms be absent from nonsterile nutritional and dietary products. A microorganism can be considered objectionable if it represents a potential health hazard to the user who is using the product as directed, or if it is capable of growing in the product. Objectionable microorganisms are defined as contaminants that, depending on the microbial species, number of organisms, dosage form, intended use, and patient population, would adversely affect product safety. Additionally, microorganisms may be deemed objectionable if they adversely affect product stability or if they may damage the integrity of the container closure system.