The Science of Quality from a Product Lifecycle Perspective
*Helen Strickland, GlaxoSmithKline 


As defined in the January 2011, FDA’s Guidance for Industry Process Validation: General Principles and Practices, process validation is “the collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product.” Process validation has been divided into three major stages; 1) process design, 2) process qualification and 3) continued process verification where the goal of each stage corresponds to developing, to demonstrating and to maintaining a process that produces product that is suitable for patient use and that is in a state of control, respectively. Justification of the data collection and data evaluation strategy (i.e. the number of batches, the number of samples, sample locations, statistical analysis, statistical confidence and the acceptance criteria) is required. This justification necessitates applying the scientific method and risk management principles to the drug product quality assessments performed throughout the product’s lifecycle. The purpose of this talk is to demonstrate that utilization of a well defined quality standard in conjunction with a well-structured quality decision framework will facilitate the development of demonstration tests (sample size and sample acceptance criteria) that can be used achieve the goals of the various process validation lifecycle stages.