PDA TR 13-2

TR-13-2 focuses on environmental controls and monitoring programs for classified areas where manufacturing processes are required to ensure a low bioburden level of the material being produced. Although a comprehensive EM program addresses both viable and nonviable aspects of the facility, this addendum concentrates primarily on the viable aspects as these parameters have a greater potential to impact product and process quality related to bioburden. This document is not intended to address EM programs for traditional aseptic or sterile manufacturing, which are covered in TR-13, nor does it address traditional nonsterile dosage forms.