Pharmaceutical Manufacturers Urged to Adopt Lean Six Sigma - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Pharmaceutical Manufacturers Urged to Adopt Lean Six Sigma


ePT--the Electronic Newsletter of Pharmaceutical Technology

Untitled Document

Philadelphia, PA (July 24)—Adopting Lean Six Sigma practices in manufacturing and clinical development can help pharmaceutical companies cut costs and bring products to market faster, according to Carmen Medina, principal of Tunnell Consulting (King of Prussia, PA). Medina gave a keynote address titled “Can Lean Six Sigma Really Help?” on the opening day of the Pharmaceutical Technology Annual Conference this year*.

The best-known ways that Lean Six Sigma aids companies, according to Medina, are by improving their yield and increasing their capacity. She detailed various other gains that the practices bring, including increased patient safety, reduced supplier variability, and enhanced business practices relating to quality assurance (QA).

Six Sigma practices are active rather than reactive, Medina said, and they therefore facilitate continuous improvement. Six Sigma changes the way companies think about their operations and sets the stage for process analysis and improvement. Medina advised that companies should take an active approach to QA. She urged companies to go beyond mere adherence to good manufacturing practices and to actively adopt lean practices for process development and manufacturing. Lean practices and Six Sigma are part of a broader approach that also includes the US Food and Drug Administration’s Process Analytical Technology and Quality by Design initiatives.

Risk assessment and management are major focuses of Lean Six Sigma, Medina noted. She underscored these topics’ importance by observing that FDA has released more guidances for risk assessment and management than for any other subject, including cleaning and validation. Because risk increases throughout the commercialization process, companies must seek continuous improvement and develop quality initiatives, Medina advised.

*The 2007 Pharmaceutical Technology Annual Conference was held in Philadelphia, Pennsylvania July 24–26. Read more.

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

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

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerTargeting Different Off-Shore Destinations
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
New FDA Team to Spur Modern Drug Manufacturing
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here