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 PAT
PharmTech: 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?
Industry roundtable participants, from left to right: Tim Freeman, managing director of Freeman Technology and past chair
of the AAPS Process Analytical Technology Focus Group; Kevin Aumiller, TOC product manager, GE Analytical Instruments; Andy
Salamon, senior staff scientist and customer advocate at PerkinElmer; Scott Samojla, senior director of Patrol process systems,
Waters; and Chris Heil (not pictured), product specialist, Antaris NIR analyzers, Thermo Fisher Scientific
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Freeman (Freeman Technology): Before focusing on specific technologies, I'd like to highlight what I believe is an important shift in the perception of
PAT over the last five years. Initially introduced by the regulators in 2004 to support efficiency in development, manufacturing,
and quality assurance, PAT has, in the intervening years, progressively proven its potential value. Collective and individual
experience has led to a widespread appreciation of the integral role that PAT will play in achieving new levels of manufacturing
efficiency and product quality, and as a result, the uptake of PAT is now increasing significantly, most notably for the information-gathering
needed to support the development of more efficient processes.
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.
