Autoclave used to sterilize items that can withstand moisture and high temperature. An autoclave or steam sterilizer is used to sterilize surgical equipment, laboratory instruments, pharmaceutical items, and other materials. Autoclave validation or qualification is mandatory to achieve a high level of sterility or quality of the product. Quality is the primordial intention of the industry and its product manufacturing. As part of the GMP, qualification is mandatory. Each company should identify what qualification work is required to prove the critical aspects of their particular operation control. Autoclaving is the most effective and efficient means of sterilization. Sterilization is a process to remove, kills, or deactivate all the microorganisms such as bacteria and spores. The purpose of this study is to give a systematic approach required for the qualification of the autoclave which contains USR, DQ, IQ, PQ, and OQ and also contains the factor that affects the sterilization and evaluation parameter test.