TR 67的目的是为非无菌产品制造业提供指导，指导其如何管理与生产和储存相关的微生物风险，以及如何确定哪些菌株会被视为非无菌产品中的不良微生物。本文件旨在全球适用。当引用特定国家的法规时，这些法规旨在作为此类法规的示例，对该国管辖范围外的行业利益相关者不具有约束力。本技术报告中没有不良微生物列表，这表明产品制造商拥有关于产品及其预期用途的所有可变信息，以便就产品的处置做出明智的决定。 这一观点与美国cGMP法规一致，该法规将排除有害微生物的责任明确指定给制造商。

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.