ABSTRACT
This chapter describes the essential elements of a protocol and the necessity to address each phase of the protocol systematically and comprehensively. The traditional notion of assuring a safe and efficacious product by inspecting in quality is being replaced by a quality systems approach where manufacturing processes and materials are rigorously tested to demonstrate their ability to produce a quality product. The secret to a successful validation effort is to provide a clear definition of what needs to be done and to communicate it via the protocol and concurrent training of all involved parties. State the range of the project and any history or supportive testing performed prior to initiation of the validation. Organize teams and give each team all of the information needed to understand the scope of its responsibilities in the validation activity. Provide diagrams, blueprints, process specifications, acceptable material specifications, sample placement diagrams, checklists, and so on that help explain the correct performance of the process.
