The GMP & ISO9001 new product planning process

This article describes only the first steps in meeting the IS09001/EN46001 standards and FDA Quality Systems regulations. A company must consider additional control systems in order to meet the Design Control requirements listed under design input, design output, design review, design verification, design transfer, design history file and design changes. Generic planning by functional departments is a basis requirement and should be available for individuals participating in product development. In addition, company management must tackle how it will structure itself in order to create new medical products in an orderly and structured manner and provide the team leader and his team with the authority and responsibilities to plan, monitor, evaluate and document a new product.