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FDA's Analytical Initiative Gathers Steam

Nov. 21, 2003
FDA's PAT Initiative Promises to Be a Long-Running Show. Stay tuned
About 30 process analyzer specialists gathered in Ann Arbor, Mich., in mid-September for the Third Pharmaceuticals Process Analyzer Roundtable (PPAR). Hosted by Pfizer, the meeting drew two dozen analyzer professionals from 10 pharmaceuticals manufacturers, a process measurement specialist from the National Institute of Standards and Technology, and the directors of the two leading process analytical academic centers (Center for Process Analytical Chemistry at University of Washington and Measurement and Control Engineering Center at University of Tennessee-Knoxville).

Clearly the process analytical technology (PAT) initiative within FDA [CONTROL--July 02, p74 and Mar. 03, p70] was at the top of everyones agenda. The formal guidance document was released on September 3 as part of FDAs comprehensive review of the existing regulatory structure for pharmaceuticals manufacturing.

The FDA is attempting to promote a more thorough understanding of pharmaceutical manufacturing processes and, with this understanding, more predictable and efficient manufacturing. Although process analyzers are potentially the vital tool, the PAT initiative has always been about process understanding, predictability, and efficiency, by whatever means can achieve this goal.

One FDA suggestion was to encourage the formation of a PAT vendors association. The pharmaceuticals industry as well as the FDA regulators could then communicate with the vendor community through a formal channel. The PPAR group and/or another analyzer user technical entity and/or the International Forum on Process Analytical Chemistry could facilitate the development of this channel.

The number of organizations interacting on the PAT initiative has become daunting. The roundtable listed 10 without much reflection. USP (officially United States Phamacopeial Convention) has established Team No. 17 to explore how PAT can affect its procedures. The NIR Validation Working Group was cited as an example of how industry expertise provided input to a substantial USP chapter revision.

USP is a non-governmental body that promotes the public health by establishing state-of-the-art standards to ensure the quality of medicines and other healthcare technologies. In 1820, 11 physicians representing various geographical regions met in Baltimore to form the USP to set standards for U.S. medicinal preparations. Anyone who has ever taken a chemistry lab course and has handled reagents has seen the USP certification probably without the slightest understanding of what that meant. I, for one, will own up to that.

The USP Council of Experts is the scientific decision-making and standards-setting body. Its 62 members, elected on the basis of their knowledge and expertise by the convention membership, exert great influence over testing procedures and how they are performed. By tailoring procedures for on-line continuous operation, the USP could give a substantial boost to the PAT initiative.

The roundtable, in exploring a more permanent role as an advisor to the Pharmaceutical Research and Manufacturing Assn. or a similar industry group, cited several roles for expediting the adoption of effective analyzer technologies in the pursuit of the new current good manufacturing practice goals. The roundtable is a large reservoir of experience with this technology in solving real industry problems. A few of the possibilities are embedding this body of experience in specifications and standards, guidance to vendors, focusing on common industry wide requirements

The 226th national meeting of the American Chemical Society, held in New York in early September, addressed the PAT initiative in an afternoon symposium. Speakers included Ron Miller of Bristol Myers Squibb, David Rudd of Glaxo SmithKline (by telephone from London), Rick Cooley of Eli Lilly, Sonja Sekulic of Pfizer Global R&D, and Ajaz Hussain of FDAs Center for Drug Evaluation and Research (CDER).

Cooley described Lillys experience with on-stream high-performance liquid chromatography (HPLC) in biosynthetic insulin production. Process applications of HPLC are notoriously complex. Raman spectroscopy was considered but its accuracy was inadequate at the very low concentrations being measured. The HPLC analysis cycle is 12 minutes and the overall reaction cycle is measured in hours.

Sekulic described experience gained by Pfizer in reaction monitoring with on-stream FTIR, NIR and Raman spectrometers. She cited a tray dryer monitoring application where an on-stream mass spectrometer was able to effect a significant reduction in the units cycle time by controlling to a measurement rather than a fixed time.

IFPAC/2004 will be January 12-15 in Arlington, Va., and will feature four technical sessions on pharmaceutical applications, including three chaired by Ali Afnan and Chris Watts of CDER. A one-day tutorial on PAT and chemometrics will be offered January 11. The Washington-area venue allows FDA greater access to this gathering. Details of the IFPAC/2004 agenda are available at www.ifpac.com or from Executive Director Robert Zutkis ([email protected]). The PAT initiative promises to be a long-running show. Stay tuned.E-mail Terrence at mcma[email protected]

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