Process Validation: General Principles and Practices U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) …

What is a process? “Process” can be defined as a “set of interrelated or interacting activities, which transforms inputs into outputs”. These activities require allocation of resources such as …

Flowchart A flowchart — also known as a “process map” — is a visual representation of the sequence of steps in a process. Understanding the process as it currently operates is an …

APQC’s Process Classification Framework (PCF)® creates a common language to discuss, benchmark, and organize the work that businesses perform. In this article, you will learn: how …

The tools the team needs to select the process to work on and establish the process improvement objective are described in the following modules of the Basic Tools for Process Improvement:

The process approach can be applied to any organization and any management system regardless of type, size or complexity. What is the process approach?

This guidance document on pharmaceutical development defines procedures for linking product and process development planning to the final commercial process control strategy and quality …