Implications and Opportunities of Applying QbD Principles to Analytical Measurements

February 1, 2010
Kevin Smith (Cephalon)

is with Cephalon

,
Matthias Pohl

is head of TechOps QA at Novartis in Basel, Switzerland, and a member of the European Federation of Pharmaceutical Industries (ADS) topic team.

,
Mark Schweitzer

is global director of global analytical R&D at Abbott Laboratories in Abbott park, IL, and a member of the Pharmaceutical Research and Manufacturers of America (PhRMA) Analytical Technical Group (ATG).

,
Jaqueline Larew

is with Eli Lilly.

,
Melissa Hanna-Brown

is with Pfizer.

,
Gordon Hansen

is vice-president of Analytical Sciences at Boehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury Rd., PO Box 368, Ridgefield, CT 06877-0368, tel. 203.798.5701

,
Phil Nethercote

Phil Nethercote is a director in New Product Support, Global Manufacturing Supply at GlaxoSmithKline (Ayrshire, UK).

,
Phil Borman

Phil Borman, is a manager in Analytical Sciences, chemical development, at GlaxoSmithKline in the UK.

Pharmaceutical Technology Europe

Pharmaceutical Technology Europe, Pharmaceutical Technology Europe-02-01-2010, Volume 22, Issue 2

The authors present two concepts to improve robustness and facilitate continuous improvement in analytical methods.

The authors present two concepts to improve robustness and facilitate continuous improvement in analytical methods.

The merits of applying quality by design (QbD) to pharmaceutical products and processes is a topic of significant mutual interest to both pharmaceutical manufacturers and regulatory agencies. The pharmaceutical industry is currently embracing QbD concepts to help improve the robustness of manufacturing processes and to facilitate continuous improvement strategies to shape and enhance product quality and manufacturing productivity. As such, both industry and regulators recognize the benefits of adopting a QbD approach to drug-product development and manufacture, with key concepts described in International Conference on Harmonization (ICH) guidelines Q8(R1) Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality System.

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