ABSTRACT
The Food and Drug Administration’s (FDA) pre-approval inspections program is an investigation by the agency to review the adequacy and accuracy of the information provided in a regulatory submission, most frequently the New Drug Application. There are a number of FDA initiatives currently underway that will significantly alter the development, approval, and manufacturing of new pharmaceutical products. One of the FDA initiatives currently underway that will significantly impact the pre-approval inspections program is that of “Pharmaceutical good manufacturing practices for the 21st Century: A Risk-Based Approach”. The FDA Office of New Drug Quality Assessment has proposed the creation of a regulatory agreement between the agency and the sponsoring company. A development quality system defines the important quality requirements that enable the firm to adequately and sufficiently explore the key elements of design space that impact the final quality of the product.
