ABSTRACT
The chapter provides insight into the background, intent, and content of the current 2011 guidance, based in part on responses to the 2008 draft guidance, Parenteral Drug Association (PDA) sponsored workshops, and related discussions, as well as discussions and updates since the issuance of the guidance. The approach presented in the FDA guidance is largely consistent with global regulatory guidance and expectations that followed. A lifecycle approach is based on the need to fully understand the relationship of product attributes, process requirements, process variables, and process controls. Knowing the background of validation is helpful to understand the evolution of modern process validation. Validation efforts in the 1970s focused on contamination control, specifically sterility assurance and sterilization. In 2006, the industry began to hear that the FDA was going to revise its 1987 Guidance on the Principles of Process Validation.
