In this first of a four-part series, the authors provide an introduction to a practical approach for establishing specification equivalence. The regulatory basis and compliance examples from FDA ...

Specifications ensure drug substances/products meet acceptance criteria, forming a foundation for robust control strategies. Validated methods must be fit for purpose, with MODRs providing flexibility ...

A quality practitioner may be interested in assessing whether two process means are statistically equivalent, e.g., whether two processes (an historical process and a new process) produce equivalent ...

What Are the Exit Criteria? Exit criteria are conditions that must be met before closing out one project stage and advancing to the next stage. When project management teams use exit criteria, they ...