VALIDATOR WHITE PAPER - Quality by Design (QBD) for Process Validation
The Pharmaceutical industry is a heavily regulated industry. It is most evident during the New Drug and Abbrievated Drug Application Process. The large amount of documentation required during this submission phase consumes a considerable amount of time and resources to prepare.
21 cfr Part 11 has been become a very large concern in the pharmaceutical industry as of late due to pressure from regulatory bodies enforcing compliance for GxP systems. Due to this, more and more organizations are realizing the criticality of employing or ramping up existing system to meet these requirements.