Using the 'Science of Quality' to Develop a Process Validation Lifecycle Plan for Pharmaceutical Products

• Activity Number: 114
• Type: Topic Contributed
• Date/Time: Monday, August 4, 2014 : 8:30 AM to 10:20 AM
• Sponsor: Biopharmaceutical Section
• Author(s): Helen Strickland*+
• Companies: GlaxoSmithKline
• Keywords: Process Validation ; Product Lifecycle ; Quality ; Statistical ; Scientific Method ; Data Evaluation Strategy

Abstract

In the 2011 Process Validation Guidance, process validation is defined as "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 is divided into three major stages; 1) process design, 2) process qualification and 3) continued process verification; the goal of each stage corresponds to developing, demonstrating and maintaining a process that produces product suitable for patient use and is in a state of control. Justification of the data collection and data evaluation strategy (i.e. number of batches, number of samples, statistical analysis, confidence and acceptance criteria) is required. Application of the scientific method and risk management principles enhance the justifications for product quality assessments performed throughout the product's lifecycle. Utilization of a well defined quality standard in conjunction with a well-structured quality decision framework facilitates development of the sampling schemes and acceptance criteria for the various process validation lifecycle stages.