spacer
home > pmps > autumn 2008 > lean machine
PUBLICATIONS
Pharmaceutical Manufacturing and Packing Sourcer

Lean Machine

Pharmaceutical manufacturing costs the industry approximately $90 billion each year and represents twice the expenditure of R&D (1). A 2001 study conducted by the MIT Pharmaceutical Manufacturing Initiative (PHARMI) indicated that significant time was spent conducting quality control (QC) testing and documenting QC results during the manufacturing process (2). Eroding profit margins from stiff competition, increasing product defects, and the FDA’s focus on a ‘quality by design model’ has led the industry to reevaluate manufacturing efficiency (1,3). The industry has recently begun adopting both lean manufacturing and Six Sigma to achieve the efficiency and quality gains achieved by other industries (4-6). IT solutions will play a significant role in managing QC standard operating procedure (SOP) documentation during the focus on lean and Six Sigma to eliminate waste, improve...

Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer
Chris Stumpf joined Waters in 2001 after earning his PhD in Analytical Chemistry and Mass Spectrometry from Purdue University in 2000, and held a post doctoral position at the University of Cincinnati Medical School conducting proteomics research. During his doctorate and post-doctorate education, he became keenly interested in informatics solutions to manage and mine analytical data.

Phil Kilby joined Waters in 1998. He received a degree in Chemistry from Greenwich University while working in drug metabolism at Rhone Poulenc in London. He is now responsible for worldwide business and partnership development of Waters’ suite of informatics solutions. Email: phil_kilby@waters.com

spacer
Chris Stumpf
spacer
spacer
spacer
Phil Kilby
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

The renewed Turkish Cargo Web Portal now offers you many conveniences with its new name ‘TK GO’

Turkish Cargo, the fastest-growing brand of the global air cargo industry, updated its web portal; a functional and user-friendly interface on Internet facilitating monitoring of all actions and providing the agents with customized solutions and facilitations.
More info >>

White Papers

Orthogonal Approaches for the Analysis of Protein Sequence and Post Translational Modifications of a Monoclonal Antibody

RSSL

Monoclonal antibodies are an important class of biopharmaceuticals. They are expressed from living cells and therefore, are subject to complex biochemical pathways. Not all of these pathways are fully understood and many are known to be sensitive to subtle environmental changes during production. These changes may affect the final biopharmaceutical sequence, structure and post-translational modifications. This is in addition to any changes that may occur during subsequent purification. This means that the final product from one batch may be subtly different from another batch. Furthermore, each batch is a heterogeneous mix of similar molecules. Analysis of the degree of batch-tobatch variation, and batch heterogeneity, is therefore, very important to establish in order to be confident that the drug is safe and effective for medicinal use.
More info >>

 
Industry Events

Pharmapack Europe 2020

5-6 February 2020, Paris Expo, Porte de Versailles - Hall 7.2 | Paris, France


More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement