抄録
In recent years, highly potent pharmaceutical products, such as anticancer drugs, have been developed or are about to be developed one after another, even if they are superior against specific diseases, and even if only a very small amount is accidentally carried over, it can cause irreversible health problems. On the other hand, the production scale of pharmaceuticals is smaller than that of general chemical products, and many of them have been manufactured in shared facilities efficiently. Until now, due to the high risk of cross-contamination in the production of highly potent ones, inspection authorities had recommended that they be manufactured in self-contained and dedicated facilities. This has led to a dilemma in which production is not efficient enough to meet the production volume, and the increased compliance costs are reflected in the cost of the drug, which in turn disadvantages the patient. With those dilemmas, the inspection authorities advocated the application of a risk-based approach to inspections, which identifies the risk of cross-contamination and scientifically assesses the risk from the standpoint of patient protection, thus paving the way for allowing highly active drugs to be manufactured in shared facilities. It should be noted that these policy changes were supported by the development of technologies such as containment and single-use technologies. Although a comprehensive revision of GMP based on a risk-based approach was underway, GMP does not clearly state how to identify risks and how to work on reducing them. We consider cross-contamination risk to be a function of “the inherent potential toxicity of a substance” and “exposure from the manufacturing process”. With this concept, based on the data of exposure measurements at pharmaceutical manufacturing sites and the literature reporting the results of exposure measurements, we have assumed the degree of “exposure” and selected the containment function. In this article, the selection method of the containment equipment （primary barrier） is introduced.
