Clinical Supplies Manufacture

Abstract The process of new drug discovery research, development, and commercialization is long, complex, and costly. It can take more than 10 years and cost $1 billion or more on average to bring a new chemical entity to the market. The new drug development process can be characterized into different phases including Phases I, II, III, and IV. The objective for each phase is described in Table 24.1. From Phase I to Phase III, clinical investigation is one of the most important activities to prove the safety and efficacy of a new drug. Successful supply of clinical materials is key to assure that clinical studies are conducted as planned at the correct time with the correct dose and correct amount of materials. Manufacturing batch sizes of clinical supplies change with demand, availability of drug substances, and study phases. A strategy clearly must be developed to effectively manage the complex clinical supplies manufacturing process. This includes planning, collaborative communication among the cross-functional team, lean manufacturing, effective training programs, and application of new technologies to facilitate the manufacture of clinical supplies. A cleaning verification and/or a cleaning validation program is a key component of the cGMP controls and quality system and an essential part of any pharmaceutical manufacturing facility. It must be demonstrated either through cleaning-validation effort that the cleaning process is under control, or through cleaning verification after each manufacture so that there is no cross-contamination from one lot to the next and the safety of product users is assured.