| Popis: |
This chapter reviews the requirements behind microbiological method validation, it is worth reviewing what critical control points in the microbiology laboratory process itself must be validated and held constant to achieve a valid test result in the first place. Classical microbiological methods based on broth and agar paradigms are inherently variable. Consistent results are dependent upon tightly controlled processes, from the manufacture of the media to its eventual application by the microbiologist. Validation of a microbiologist’s aseptic technique is obvious and is often demonstrated though media fill studies, gowning qualifications, transfer studies, and other means. Microbial variability has significant implications in performance of out of specification investigations. Validation of microbiological methods is a critical component of safe drug delivery. The bioburden of raw materials, efficacy of cleaning and disinfection, and control of viable air particles are just some of the control points that rely on valid microbiological methods to demonstrate they are operating within limits. |
