PDA TR 67

The purpose of TR 67 is to provide guidance to the nonsterile product manufacturing industry on how to manage the microbial risks associated with manufacturing and storage as well as how to determine what isolates would be deemed an objectionable microorganism in nonsterile products. This document is intended to be globally applicable. When country-specific regulations are cited, they are meant to serve as examples of such and are not binding to the industry stakeholders outside the country's jurisdiction. The absence of a list of objectionable microorganisms from this technical report acknowledges that the manufacturer of the product has all of the variable information, about a product and its intended use, needed to make an informed decision regarding the product's disposition. This belief is consistent with the U.S. cGMP regulations, which assign the responsibility for excluding objectionable microorganisms specifically to the manufacturer.