When it comes to quality assurance in a pharmaceutical company, students may think mainly of the business content of product quality control, pharmaceutical affairs, and quality assurance. In reality, there are several steps in the drug development activities of pharmaceutical companies, and each step must be dealt with from the perspective of quality assurance. For example, when conducting a pharmacological experiment using cells or animals, a study plan to be prepared before the experiment, information on the source of cells or animals used in the experiment, acquisition records and usage records of reagents to be used, storage of raw data and guarantee of accuracy of processed data after analysis, appropriate tatistical analysis method, study report containing the above information are required to guarantee the study results. For studies other than pharmacological studies, not only study plan and study report are required, but also studies are required to be conducted under the conditions stipulated by the Ordinance of the Ministry of Health, Labor and Welfare. Non-clinical toxicological studies and pharmacokinetic studies are conducted under GLP (Good Laboratory Practice), clinical studies are conducted under GCP (Good Clinical Practice), and product manufacturing control is conducted under GMP (Good Manufacturing Practice). Efforts are underway to protect patient’s health and safety.