Implications and Opportunities of Applying QbD Principles to Analytical Measurements - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe
Implications and Opportunities of Applying QbD Principles to Analytical Measurements
Feb 1, 2010
By: Mark Schweitzer, Matthias Pohl, Melissa Hanna-Brown, Phil Nethercote, Phil Borman, Gordon Hansen, Kevin Smith (Cephalon), Jaqueline Larew
Pharmaceutical Technology Europe
Volume 22, Issue 2

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.

Click here to read the full article

ADVERTISEMENT

blog comments powered by Disqus
About the Author

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). Articles by Mark Schweitzer

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. Articles by Matthias Pohl

Melissa Hanna-Brown

is with Pfizer. Articles by Melissa Hanna-Brown

Phil Nethercote

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

Phil Borman


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

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 Articles by Gordon Hansen

Kevin Smith (Cephalon)

is with Cephalon Articles by Kevin Smith (Cephalon)

Jaqueline Larew

is with Eli Lilly. Articles by Jaqueline Larew
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
How does your company apply quality-by-design (QbD) principles to manufacturing processes?
To all processes for both new and legacy products
To all process for new products only
To select process for new products only
To select processes for both new and legacy products
Do not use QbD
To all processes for both new and legacy products
18%
To all process for new products only
14%
To select process for new products only
23%
To select processes for both new and legacy products
20%
Do not use QbD
25%
View Results
UPCOMING CONFERENCES

Programs for Investigational and Pre-Launch Drugs
Philadelphia, PA
July 17-18, 2013
Request Brochure

Strategic Pipeline Planning & Portfolio Valuation
Philadelphia, PA
August 13-14, 2013
Request Brochure

MES 2013 - Forum on Manufacturing Execution Systems
Philadelphia, PA
August 14-15, 2013
Request Brochure

Mobile Innovation for the Life Sciences Industry
Philadelphia, PA
August 20-21, 2013
Request Brochure

See All Conferences >>
Eric Langer Outsourcing Outlook Eric LangerOutsourcing's Modest Role as a Cost-Containment Strategy
Patricia Van Arnum Ingredients Insider Patricia Van ArnumIntellectual Property Battles in Solid-State Chemistry
Nathan Jessop Industry Insider Nathan Jessop Campaign Against Counterfeit Drugs Continues
Lynn Torbeck Statistical Solutions Lynn D. TorbeckCompositing Samples and the Risk to Product Quality
 More
Inadequate Access to Medicines Puts EU at Risk
FDA Offers Insight on QbD for Modified-Release Products
Global Biosimilars Market to Reach $2.445 Billion in 2013
Adapting to Change
AstraZeneca and Exco InTouch Collaborate to Augment Current COPD Pathways
FindPharma Custom Search
Featured Jobs

More Jobs
Source: Pharmaceutical Technology Europe, 2/1/2010
 Click here