In Business Since 2001 We accept Paypal
Home for Writers for Publishers Article Directory Article Search
Guides
Article Marketing Secrets
20-Min Article Writing
Author Resource Box
35 Traffic Strategies
Kindle Uploads 101
Fantastic Fiction Decoded


Click Here to
see on Amazon


Site Navigation
Home

Writing Services
+ FAQ

FAQ

+ About Us
+ Blogs
Search Tools
+ Search Our Articles
Article Directory
+ Authors
+ Articles
Other Sites We Own
Writing Puzzle

Professional Book Marketing

Platt Publishing

Marketing Help


 
Article Teaser: The pharmaceutical industry wastes more than $50 billion a year in manufacturing costs according to findings of a study conducted jointly by Olin School of Business at Washington University and McDonough School of Business at Georgetown University. The goal of the study was to understand how the FDA regulates pharmaceutical production and how those regulations may be inhibiting advances in manufacturing. Quality by Design ensures reduced deficiencies, quicker approvals, and improved interaction with FDA. It also allows for continuous improvements in products and manufacturing process, as well as a better understanding of how APIs and excipients affect manufacturing.

Keep reading below...

Quality by Design Streamlines Pharmaceutical Manufacturing

Copyright (c) 2008-2017

The pharmaceutical industry wastes more than $50 billion a year in manufacturing costs, this according to findings of a study on the interplay of pharmaceutical manufacturing and the Food and Drug Administration (FDA). The study, conducted jointly by Olin School of Business at Washington University and McDonough School of Business at Georgetown University, received no funding from either the pharmaceutical industry or the FDA.

The goal of the study was to understand how the FDA regulates pharmaceutical production and how those regulations may be inhibiting advances in manufacturing. The study looked at data collected from 42 manufacturing facilities owned by 19 manufacturers, in particular each company?s manufacturing performance in terms of cycle time, frequency of deviations, reasons for deviations, yield, and improvement rates on key manufacturing metrics.

The outcome identified two factors that could be assisted by Quality-by-Design. First, companies using information technology to electronically track and report on manufacturing and centrally stored all their data displayed superior manufacturing performance relative to those not using such information technology. Second, the ability of employees in lower ranks to make decisions directly correlated to gains in manufacturing performance, particularly regarding deviation management, lot failure, lot review and process validation.

The FDA?s Quality by Design (QbD) initiative has shifted quality control from a static end result to an ongoing, evolving entity?one that tracks a product from inception to creation, rather than looks only at the final product. The QbD initiative, which originated from the Office of Biotechnology Products (OBP), attempts to provide guidance on pharmaceutical development to facilitate design of products and processes that maximizes the product?s efficacy and safety profile while enhancing product manufacturability.

Fundamental to this initiative is the understanding of the relationship between the quality attributes of the product (physicochemical and biological properties) and their impact on the safety and efficacy. This requires knowledge of the relationship between structure and biological functions.

In short, QbD is a scientific, risk-based, holistic and proactive approach to pharmaceutical development, as well as deliberate design effort from product conception through commercialization. QbD offers a full understanding of how product attributes and process relate to product performance.

The initiative benefits everyone by ensuring better design of products with less problems in manufacturing. It also reduces the number of manufacturing supplements required for post market changes, and allows for implementation of new technology to improve manufacturing without regulatory scrutiny, as well as possible reduction in overall costs of manufacturing.

QbD ensures reduced deficiencies, quicker approvals, and improved interaction with FDA. It also allows for continuous improvements in products and manufacturing process, as well as a better understanding of how APIs and excipients affect manufacturing. Lastly, it relates manufacturing to clinical during design, and provides a better overall business model.


About The Author: Shop Amazon - Top Gift Ideas
Norm Howe, Senior Partner at Validation and Compliance Institute, consultants for the pharmaceutical and medical device industries. He got his BS at UC, Berkeley, and a Ph.D. in chemistry at UCLA. He has held many management positions in FDA regulated industries, most at BASF. http://www.vcillc.com

Follow "The Phantom Writers" on Twitter (@phantomwriters)
to be notified when new articles are made available.


VOTE ON THIS ARTICLE
Needs Work >> 0 - 1 - 2 - 3 - 4 - 5 << Excellent Article

Tell our authors what you think about their article.



Top-Level Category: Shopping Articles || Related Categories: Career Articles

10 Most Recent Articles Written by Norm Howe

Where Will FDA Target Next? What IVD Manufacturers Should Know Before Their Next FDA Audit
Written by: Norm Howe | Distributed: 2011-09-12 | Word Count: 706 | Page Views: 537
Medical device manufacturers are always interested in knowing what FDA's next area of focus will be. Well, if you're an In Vitro Diagnostic manufacturer you might review your measurement systems.

How to Evaluate the Quality of a Dietary Supplement
Written by: Norm Howe | Distributed: 2010-11-02 | Word Count: 751 | Page Views: 2822 | Votes: 5 | Rating: 0.80
So, you've found a Dietary Supplement that exactly fits your special need. The information on the supplier's website appears to be consistent with everything that you've read and heard, and now you're ready to buy. But there are questions on your mind. "What is the quality of this product that I'm buying?" you ask. "Can I really trust this supplier?"

Off-Label Use of Medical Devices
Written by: Norm Howe | Distributed: 2010-06-22 | Word Count: 621 | Page Views: 3460 | Votes: 1 | Rating: 4.00
How can a medical practitioner decide whether a medical device that they want to use for one of their patients is legal and approved by the Food and Drug Administration? When a patient comes into a physician's office the patient is looking for the best, most modern care they can get. And a physician certainly wants the same thing.

A New Paradigm to Address the High Cost of Vendor Qualification
Written by: Norm Howe | Distributed: 2010-01-12 | Word Count: 1160 | Page Views: 2189 | Votes: 4 | Rating: 1.50
The assumption today is that a BETTER audit means a LONGER audit. There has to be another way. What's needed is a new paradigm for vendor qualification; a tool that can drill deeply into the vendor's operation at low cost; something that can provide a more lasting measure of the vendor's performance than simply an audit...

FDA's New Process Validation Guidance Recommends Team Approach
Written by: Norm Howe | Distributed: 2009-03-10 | Word Count: 666 | Page Views: 3087 | Votes: 7 | Rating: 0.86
The November 2008 FDA draft guidance for process validation says "We recommend an integrated team approach to process validation that includes expertise from a variety of disciplines..." But when different people from different backgrounds work together, disagreements can stall your team. How do you get your project back on track?

The Myth of the Generic SOP
Written by: Norm Howe | Distributed: 2009-03-03 | Word Count: 687 | Page Views: 2579 | Votes: 6 | Rating: 2.50
What do you do when your boss tells you to write an SOP? Run and hide? Tell her how long it will really take to write one that's any good? If you choose the latter option, be prepared for this "helpful suggestion": "Why don't you just download a generic SOP from the internet?" You would have been better off taking the former option. Here's why.

The Evolution of Process Validation
Written by: Norm Howe | Distributed: 2009-01-27 | Word Count: 471 | Page Views: 4373 | Votes: 13 | Rating: 1.69
In November 2008, the U.S. Food and Drug Administration (FDA) published draft guidance on process validation. Entitled Process Validation: General Principles and Practices, this draft guidance replaces the previous guidance issued in 1987. What does this mean to you?

FDA's New Process Validation Guidance Recommends Team Approach
Written by: Norm Howe | Distributed: 2009-01-21 | Word Count: 665 | Page Views: 4294 | Votes: 7 | Rating: 3.43
The November 2008 FDA draft guidance for process validation says "We recommend an integrated team approach to process validation that includes expertise from a variety of disciplines..." But when different people from different backgrounds work together, disagreements can stall your team. How do you get your project back on track?

Proposed FDA Compliance Guide to Assist Small Dietary Supplement Manufacturers
Written by: Norm Howe | Distributed: 2009-01-05 | Word Count: 440 | Page Views: 2339 | Votes: 6 | Rating: 1.67
How do small Dietary Supplement manufacturers comply with the new Dietary Supplement GMPs? The U.S. Food and Drug Administration (FDA) announced plans to publish a compliance guide that will provide assistance to small dietary supplement manufacturers.

Dietary Supplements Must Be Tested by Scientifically Valid Methods
Written by: Norm Howe | Distributed: 2008-09-03 | Word Count: 424 | Page Views: 3084 | Votes: 6 | Rating: 1.00
Are you a Dietary Supplement manufacturer trying to figure out what FDA means by "Scientifically Valid Method"? Here are some hints.

All of Author's Articles on this site:

Most Recent "Shopping" Articles

From Becoming the Perfect Stranger to the Perfect Partner
Written by: Kandice Skaggs | Distributed: 2013-10-15 | Word Count: 843 | Page Views: 1554 | Votes: 3 | Rating: 0.33
Although we are aware of people who have fostered good relationships out of online dating, it doesn't happen all the time. As a matter of fact, most of them fail because of a slew of reasons. Here are some reminders on how to walk that ground so you can become just the right partner that another has been dying to meet.

Choosing Rainwear
Written by: Rathi Niyogi | Distributed: 2010-11-04 | Word Count: 741 | Page Views: 2778 | Votes: 1 | Rating: 2.00
Rainwear does more than simply keep out rain or snow, it protects from wind, cold, and chemical splashes. Your choice of rainwear depends on the expected weather, the expected temperatures, your planned activities, and your budget. Rainwear materials and designs greatly affect the performance you can expect. There are three major types of rainwear:

Celebrity Perfume Gift Sets Are Always Welcome
Written by: Robert Moore | Distributed: 2010-08-05 | Word Count: 736 | Page Views: 2853 | Votes: 1 | Rating: 5.00
Perfume is one of the best gifts for your loved ones on almost every occasion, whether it is Valentine's Day, Birthday, Wedding Anniversary, or even Christmas Day.

Best Cologne Gift Sets Are A Great Idea For Men
Written by: Robert Moore | Distributed: 2010-07-29 | Word Count: 770 | Page Views: 3076 | Votes: 6 | Rating: 2.50
Hair, clothing and looks are important, but the right cologne transforms a man. Giving him the confidence to know he smells good when approaching beautiful women in a club or giving a presentation for work. When it comes to fragrances for men companies now understand that men want to smell good while attending parties, formal events, the office, on a date or simply while relaxing at home.

Must-See 2010 Summer Music Festivals
Written by: Ryan Hogan | Distributed: 2010-04-28 | Word Count: 885 | Page Views: 2982 | Votes: 3 | Rating: 0.67
One of the best things about summer, at least for music fans, is the plethora of music festivals held all across the country and all though out the season. These festivals bring together dozens of great bands usually for more than one day and usually on more than one stage.

How Does A Blu-ray Disc Work?
Written by: Titus Hoskins | Distributed: 2010-04-27 | Word Count: 444 | Page Views: 3759 | Votes: 7 | Rating: 1.00
Blu-ray Players are all the rage in home entertainment, but how exactly does a Blu-ray disc work and why is it so much better than a regular DVD disc or system? Read this informative article to discover how a Blu-ray disc works.

Understanding Personal Injury Law and Knowing When You Need a Personal Injury Lawyer
Written by: Keith Stachowiak | Distributed: 2010-03-10 | Word Count: 497 | Page Views: 2356
When in an accident caused by someone else's carelessness or deliberate actions, one of the first thoughts that goes through most people's minds after the panic and relief subsides, is whether they should seek out a personal injury lawyer. Before you make this decision, you should know what personal injury law is, whether you even need a personal injury lawyer, and when you should choose one.

Tattoos Have Transformed From Mom To Artwork Of The 21st Century
Written by: Bree Levine | Distributed: 2010-02-25 | Word Count: 554 | Page Views: 3932 | Votes: 4 | Rating: 0.50
You could call it a 21st century art form: people use their bodies as living displays of what they care about in the form of pictorial art. Over time, tattoo artists have become more and more sophisticated, able to create complex and well-executed designs.

The Best Traditions And Advice For The Tattooing Experience
Written by: Eileen Howerton | Distributed: 2010-02-24 | Word Count: 566 | Page Views: 2351 | Votes: 2 | Rating: 0.00
The ritual of tattooing and adorning the body with ink and color has been a tradition for centuries. Tattooing is definitely not a fad, or a practice reserved to any particular element of society. It is a tradition that has been found in all parts of the world, in different sects of society.

Shopping Online to Save Time and Money
Written by: Janet Davis | Distributed: 2009-12-31 | Word Count: 880 | Page Views: 2376 | Votes: 2 | Rating: 2.50
There is a certain convenience in shopping from the comfort of one's own home, a convenience that has been met in the past through mail-order catalogs, shopping television channels, and home-delivered grocery services. With the advent of the Internet and the World Wide Web, this trend has reached its culmination and most elegant expression yet.

Most Viewed "Shopping" Articles

Pearl Necklace Clasps
Written by: Norma Jones | Distributed: 2006-08-04 | Word Count: 1546 | Page Views: 26388 | Votes: 50 | Rating: 2.80
The clasp on a strand of pearls is both the frosting and sugar sprinkles on a cake. In addition to keeping the necklace fastened, the clasp should also complement you and your pearls. As your necklace and bracelet are regularly restrung, you can also update the clasps to meet your changing needs.

Be Prepared - The Pros And Cons of Non-Lethal Self-Defense Weapons
Written by: Brodie Abbot | Distributed: 2006-11-14 | Word Count: 938 | Page Views: 18200 | Votes: 39 | Rating: 2.31
In today's world, there are many means by which people can protect themselves. When thinking about self-defense, many people only consider martial arts or firearms. In truth, these are only two options from an array of self-defense mechanisms available. Through increased use in recent years, the advantages and disadvantages of stun guns, tasers, and pepper spray have become clear. All three items offer non-lethal means of protection, but one of them may be more appropriate than the others in a given situation.

Real and Imitation Pearls
Written by: Norma Jones | Distributed: 2006-06-22 | Word Count: 773 | Page Views: 12419 | Votes: 29 | Rating: 2.97
We are often asked how to tell if pearls are real or imitation. To start, we'll need to look at pearl growth and different types of imitation pearls. Then, we'll look at different pearl tests.

Alberta Angling Tournaments: Spectacular Scenery, Big Purses
Written by: Travel Alberta | Distributed: 2006-10-30 | Word Count: 963 | Page Views: 9171 | Votes: 6 | Rating: 2.83
Alberta's fishing tournaments pit angler against angler in a quest for the biggest shimmering walleye and a slice of the $60,600 (Cdn) in prize money.

How To Choose The Right Mold Testing Firm
Written by: Daryl Watters | Distributed: 2007-07-05 | Word Count: 566 | Page Views: 8553 | Votes: 14 | Rating: 3.00
You may be ill because of mold in your home or place of employment, your property value may fall because of mold that bleach and paint just cannot control. If you have a compromised immune system mold may even grow in you lungs or other parts of your body in the form of a systemic fungal infection. However, no requirements exist for mold inspectors nor mold remediators in most states. When choosing a mold testing firm be sure that the professional is familiar with the following.

Bosses Day: 25 Wallet-Friendly Gift Ideas
Written by: Darlene Arechederra | Distributed: 2006-08-23 | Word Count: 799 | Page Views: 8324 | Votes: 6 | Rating: 3.67
Bosses Day is right around the corner again -- but no need to panic! You still have plenty of time to find a great gift. The good news is that finding the perfect gift for your boss doesn't need to drain your wallet. Read on for some practical and low-cost gift ideas, including gifts for bosses with special circumstances.

Emma Watson Is A Real Sweet Pea
Written by: Wesley Berry, AAF | Distributed: 2008-02-06 | Word Count: 424 | Page Views: 8311 | Votes: 23 | Rating: 2.22
Harry Potter co-star Emma Watson, who plays super-smart Hermione Granger, turned sweet sixteen on April 15, 2006. From all accounts, she's as sweet as any sixteen-year-old can be. So sweet, in fact, that her birth flower is the sweet pea!

Celebrities And Their Favorite Flower Finds
Written by: Wesley Berry, AAF | Distributed: 2007-12-19 | Word Count: 756 | Page Views: 8201 | Votes: 10 | Rating: 2.20
While we all have our own choices of favorite flowers, the top picks for the latest flower trends and bouquets take more than a trip to the local florist.

How To Tell If Your Clothes Are Dirty
Written by: Theresa Bane | Distributed: 2008-05-28 | Word Count: 1984 | Page Views: 6814 | Votes: 18 | Rating: 3.72
If you are the type of person who wears clothes, like, t-shirts for example, than this is an article for you. You may not be aware of it, but your favorite t-shirt that has a clever or funny saying emblazoned across it's width can actually reach a level of funk that requires it to be laundered.

Interior Window Shutters Can Be Affordable
Written by: Brian Wright | Distributed: 2008-07-21 | Word Count: 757 | Page Views: 6691 | Votes: 14 | Rating: 3.14
Avoid spending high dollar for custom-made interior window shutters. You can obtain affordable interior shutter panels, finish, and install them yourself. Find tips on measuring, selecting, and ordering quality stock-size interior shutters.

Highest Ranked "Shopping" Articles

Private Label Bottled Water And School Fund Raising
Written by: Marcus Stout | Distributed: 2007-04-24 | Word Count: 1130 | Page Views: 4331 | Votes: 9 | Rating: 3.89
Like most organizations, schools in the United States are subject to constant budget stress. Important athletic and scholastic programs are subject to budget cuts as demographics change and taxpayers become increasingly budget aware. As a result, schools include fund raising resources in their planning for programs.

Get Peace Of Mind With These 10 Questions For Your Jeweler
Written by: Marc Choyt | Distributed: 2007-09-06 | Word Count: 1039 | Page Views: 2270 | Votes: 7 | Rating: 3.86
Many consumers want to purchase ethically sourced jewelry yet they do not know enough about this emerging product category to even begin to talk to their jewelry. This article provides knowledge and the right questions to empower the consumer interested in purchasing social responsible jewelry.

Paris Hilton's Family Understands The Relaxation Of Flowers
Written by: Wesley Berry, AAF | Distributed: 2008-04-23 | Word Count: 389 | Page Views: 3012 | Votes: 6 | Rating: 3.83
Ask Paris Hilton what she thinks of flowers and she's likely to give her trademark response, "They're hot!" And, I'm certain that if you walk into any hotel in the Hilton line and you're very likely to see some beautiful flowers adorning the lobby and other public areas. That's because people in the decorating and design industry, such as those responsible for the interior design of Hilton hotels, understand that flowers are an excellent way to make people feel welcome and relaxed.

Tea: Ordering Green Tea Online
Written by: Jon M. Stout | Distributed: 2007-06-05 | Word Count: 890 | Page Views: 3774 | Votes: 6 | Rating: 3.83
If you've started to become a green tea enthusiast, no doubt you've realized that there are an overwhelming number of green teas from which to choose. Just the number of green teas varieties in China are too many to list. You may have an interest in trying them all but that will take you quite a while!

Do It Yourself Mold Testing Kits
Written by: Daryl Watters | Distributed: 2007-05-29 | Word Count: 729 | Page Views: 5051 | Votes: 9 | Rating: 3.78
If you feel that you have a mold problem, you can save money on a mold inspection by buying a mold testing kit from your local South Florida building supply store.

Lindsay Lohan's Color Sense
Written by: Wesley Berry, AAF | Distributed: 2008-03-27 | Word Count: 400 | Page Views: 3157 | Votes: 8 | Rating: 3.75
Young movie starlet Lindsay Lohan has recently begun to be noticed for her fashion sense, including her oft-changing hair color. The use of color is certainly important in the fashion industry, but there's another industry where it's perhaps even more important-the floral industry.

How To Tell If Your Clothes Are Dirty
Written by: Theresa Bane | Distributed: 2008-05-28 | Word Count: 1984 | Page Views: 6814 | Votes: 18 | Rating: 3.72
If you are the type of person who wears clothes, like, t-shirts for example, than this is an article for you. You may not be aware of it, but your favorite t-shirt that has a clever or funny saying emblazoned across it's width can actually reach a level of funk that requires it to be laundered.

Odors From Hidden Mold And Your Health
Written by: Daryl Watters | Distributed: 2008-05-14 | Word Count: 1717 | Page Views: 3644 | Votes: 7 | Rating: 3.71
Article on the often overlooked health effects of exposure to microbial volatile organic compounds or mvoc also known as mold odor. How mold odor can cause indoor air quality problems from home owners and building occupants, and how mold inspectors testing for spores often overlook this potential health threat.

Bosses Day: 25 Wallet-Friendly Gift Ideas
Written by: Darlene Arechederra | Distributed: 2006-08-23 | Word Count: 799 | Page Views: 8324 | Votes: 6 | Rating: 3.67
Bosses Day is right around the corner again -- but no need to panic! You still have plenty of time to find a great gift. The good news is that finding the perfect gift for your boss doesn't need to drain your wallet. Read on for some practical and low-cost gift ideas, including gifts for bosses with special circumstances.

Eco Friendly Home Accents Are in Demand
Written by: Kris Bond | Distributed: 2009-03-03 | Word Count: 632 | Page Views: 2641 | Votes: 6 | Rating: 3.67
The Eco Friendly trend continues to grow.... not falling short of entering the home. For the past several years manufacturers of all the different industries and local retail stores have been in search of ways to save the environment - or at least preserve what can be.












Download an eBook today
 
Directory Navigation
Locate By Author

Locate By Category:
ALL Categories
Arts & Crafts
Arts & Entertainment
Automotive
Business - Offline
Business - Online
Career
Computers
Education
Family
Finance
Food & Drink
Health & Wellness
Home & Garden
Humor
Internet
Nature & Pets
Real Estate
Religion
Self Improvement
Shopping
Society
Sports & Recreation
Technology
Travel & Leisure
Uncategorized
World Events
Writing & Speaking

Change Number of Results:
50 - 100 - 200 - 500
Article Reprint Rights
Creative Commons License

This work is
licensed under a
Creative Commons
License


You are not required to show the creative commons license notice when you reprint this work.
Article Publishing Tools
Print Article
Email-to-Blog
HTML Source Code
Text Newsletter Format
Link Back HTML

Blog Publishing Tools

Internal ID: #6141
Article Statistics
Word Count: 453

Total Views: 3265

Article Rating: 2.80 of 5
Votes Cast: 5

More Articles By Author:




Article Title Search:

Widow Search
Right Blinker
Google
Yahoo!
Zuula
Bing
Cuil

Last Distribution Date:
2008-06-24 11:12:00






All Articles are Copyright © 2001-2017 of the Defined Authors.

All other material and images on this site are:
Copyright © 2001-2017, ThePhantomWriters.com