In this review, we organize the concept of insoluble particulate matters in injections, and report the research results conducted by the Aseptic Product GMP Committee of the Japan PDA Pharmaceutical Society and the background, overview and prospects regarding the newly established program.
Although the requirements for visual inspection in JP, USP and EP are harmonized, all are qualitative expressions only, and there are no specific criteria for insoluble particulate matter size or probability of detection. For this reason, visual inspection depends on the ability of inspectors, and a framework for objective evaluation and ability maintenance related to inspectors is important. In order to standardize and visualize the “visible” capability of inspectors, the Aseptic Product GMP Committee prepared a standard ampoule kit and conducted a comparative study between different manufacturing sites.
In addition, based on the unification of education level that differs among companies and the necessity of supervisors, a training program consisting of two courses for visual inspectors and supervisors was established. In particular, a training program for certified supervisors is meaningful to ensure the qualification of education and evaluation for inspectors, and systematic preparation of educational materials is the first attempt. We expect this training program to standardize the visible capability of inspectors between different manufacturing sites and reduce risks for insoluble particulate matters.
