Method VaIidation/Verification: How Important is it in Your QC Microbiology Laboratory?

摘要

Method Validation/Verification? The ever so daunting words in any Good Manufacturing Practice (GMP) Quality Control (QC) Microbiology Laboratory. If you are a new lab manager and/or analyst just starting in the pharmaceutical industry, various questions come to mind when you think of these terms: Method Validation and Method Verification. As these questions start forming, you may ask yourself "Why do we need to do method validation or verification? Which methods do I use when validating my product? When do I validate my laboratories methods? Where do I even begin? Who is requiring me to execute these in my lab? What is required to have a successful validation?"