Environmental monitoring in compounding injectable oncology drugs as per current legislation

Abstract

The compounding of injectable oncology drugs is an activity of the pharmaceutical segment of great relevance and complexity. It requires biosafety actions to minimize environmental and occupational contamination, and environmental conditions associated with the aseptic technique for maintaining sterility. They are extemporaneous preparations, exempt from sterility testing, therefore, strict control of the preparation process is necessary. Environmental monitoring in an injectable compounding cleanroom, a requirement of Brazilian legislation that affords good compounding practices, is a tool used to demonstrate that the environment production meets the requirement of  quality standards. However, the national regulations do not establish how to do it or the acceptable standard of compliance. This lack of information allows that methods without reference standards exist, and that the final product may be inadequate for the requirements regarding safety, integrity and reliability. As a conclusion, this debate shows the requirements of international regulations regarding environmental monitoring in compounding injectable drugs, drawing a counterpoint with the main national and international industrial standards and guidelines. Although products manufactured and handled by an aseptic process have to maintain the same sterility characteristic, there are divergences in methods and  acceptable limits of contamination, questioning whether flexibility is    possible in terms of quality  requirements. It is also important to highlight the need for the Brazilian regulatory agency to update the rules for the pharmacy for handling injectable drugs, to assist it in the effective implementation of an environmental monitoring program in order to contribute to the strengthening of the Quality  Management System in Health Services.