When FDA first announced in 2002 a new initiative, Pharmaceutical Current Good Manufacturing Practices (CGMPs) for the 21st Century, and later issued its report, Pharmaceutical cGMPs for the 21st Century—A Risk-Based Approach, in 2004, it put into motion an effort to enhance product quality and modernize pharmaceutical manufacturing through a science- and risk-based approach under quality-by-design principles (QbD) (1). That effort was further encouraged by the issuance of guidance on process analytical technology (PAT) in 2004 to facilitate the introduction of new technologies that would enhance process understanding and assist in identifying and controlling critical points in a process (2). These technologies include: appropriate measurements devices, which can be placed at-, in-, or on-line; statistical, and information technology tools; and a scientific-systems approach for data analysis to control processes to ensure production of in-process materials and final products of desired quality (3).
So how far has the industry come in advancing PAT and where may future innovation lie? Pharmaceutical Technology conducted an industry roundtable to gain perspective on advances in analytical instrumentation and methods development. Participating are: Tim Freeman, managing director of Freeman Technology and past chair of the Process Analytical Technology Focus Group of the American Association of Pharmaceutical Scientists; Kevin Aumiller, TOC product manager at GE Analytical Instruments; Andy Salamon, senior staff scientist and customer advocate at PerkinElmer; Chris Heil, product specialist, Antaris NIR analyzers at Thermo Fisher Scientific; and Scott Samojla, senior director of PATROL process systems at Waters.
Advances in PATPharmTech: On an industry level, what would you identify as the most significant advances in PAT used in the pharmaceutical industry during the past five years?
This focus on information-gathering and process monitoring is reflected in the technologies that have advanced most during the past five years. The use of on- or in-line systems with a proven track record has increased considerably but so too has the application of at-line methods that provide unique information and insight.