pharmaceutical magazine

Quality Progress - June 2008

Far-Sighted

In the first year nonprofit organizations could apply for the honor, Coral Springs became the first local government to take home a Baldrige award by proving it didn't emphasize the present at the expense of the future....

Customer Servicemen

Customer Feedback is a key component of improvement. The challenge has always been finding the most effective way of procuring it....

Incredible Journey

In response to personnel’s safety concerns and rising workers’ compensation costs, a team at Boeing’s C-17 site developed a solution to thwart injury and save money....

Two Are Better Than One

Management need and my personal curiosity recently led me to take a closer look at the Sarbanes-Oxley Act (SOX). My work pointed out similarities and differences between SOX and ISO 9001....

The True Test of Loyalty

The customer loyalty field has experienced much technological innovation, such as automated reporting portals and integration of attitudinal and behavioral data in customer relationship management applications, over the past decade....

Who's Keeping Score?

There’s one tool you won’t find for sale at Sears. One of the retail giant’s divisions has started using a quality management tool extensively to maintain and improve its own quality management system....

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Quality Progress - February 2008

Sharpen Your Auditing Skills

Effective audits require effective audit planning. One of the best tools to help guide both the planning and execution of an audit is the audit checklist....

Efficiency Gets a New Identity

This article demonstrates the impact RFID will have on existing supply chain processes and the improvements RFID implementation will bring by comparing the benefits of RFID with those of barcode for various supply chain entities. The increases in data cap..

Educating Engineers

Statistics is an indispensable tool for solving engineering problems. But many engineers are not exposed to problems that require the use of statistical methods until they start their professional careers....

Good Vibrations

Modern quality management principles define quality as customer satisfaction with product and service. SCGC has a web page where guitar owners can have questions about their guitars answered by Hoover or Roberts. With employee empowerment accompanying goo...

Launch to Quality

After using different quality methods with limited success, the Naval Surface Warfare Center, Indian Head Division, implemented lean Six Sigma in 2004. Through all of this, leadership demonstrated a steadfast commitment to fully implementing lean Six Sigm...

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Quality Progress - March 2008

A Framework for Business Ethics

Profit maximization is, of course, the main and foremost objective for any commercial organization. Most modern organizations realize that to survive in today’s competitive arena, customers have to be satisfied....

A Gold Medal Solution

Additionally, the production team's performance wasn't meeting its organizational goals—including quality, timeliness, efficiency and cycle time—for continuous improvement. Internal stakeholders included those from in-plant manufacturing, safety, and prod...

The Remedy for a Data Dilemma

In 1994, Bellin Health volunteered for a pilot assessment managed jointly by the Baldrige National Quality Program and the Joint Commission. This assessment helped Bellin focus on developing an integrated measurement system....

Strong Foundation, Solid Future

In the wake of the scandals five years ago that shook consumer confidence in business leaders and the economy, I co-wrote an article about the resurgence of social responsibility on the corporate landscape and increased public awareness on the topic....

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Controlled Environments - November 2008

BIOLOGICAL SAFETY CABINETS: CONTROLLING CONTAMINATION David Phillips 16

ACHIEVING TRUE EH&S IN CONTROLLED ENVIRONMENTS

Matt Kopecky

CLEANROOM FACILITY CONSTRUCTION OPTIONS

REGULATORY FORUM:

PREDICTING THE FUTURE
Bikash Chatterjee

CONTAMINATION CONTROL IN AND OUT OF THE CLEANROOM

THINKING OUTSIDE THE BOX (OR AT LEAST OUTSIDE THE SEM)
Barbara Kanegsberg and Ed Kanegsberg

C4: CRITICAL CLEANING FOR CONTAMINATION CONTROL

MAYBE HEISENBERG WAS WRONG, AND EINSTEIN RIGHT?
John Durkee, Ph.D., P.E 9 EDITOR’S LETTER 25 PRODUCT FOCUS:

INSTRUMENTATION
BUSINESS MARKETPLACE

PENCIL IT IN

ADVERTISER INDEX
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CleanRooms - Magazines (Jan 08 to Oct 08)

Magazine of contamination control and clean manufacturing for clean room professionals in the semiconductor, biotechnology, life sciences, and cosmetic manufacturing.

The entire package of the year 2008 from January to September.
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Regulatory Focus - September 2008


Where is our profession headed?

A Seat at the Table:Regulatory in Corporate Health care

Managing Global Business Risk:The New Role of Regulatory Leaders

Mergers, Acquisitions and Operational Risk

The Regulatory Professional:A Jack of All Trades

Regulating Nanotechnology in the US & EU


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Powder and Bulk Engineering International Sep/Oct-2008

Powder and Bulk Engineering International [ISSN 1098-6480] is pub -lished six times a year in January, March, May, July, September, and November by CSC Publishing, Inc., 1155 Northland Drive, St. Paul, MN 55120. After several years of not being published, Powder and Bulk Engineering International is back!

ARTICLES:

Basic criteria for selecting a bagging system Walter Kersting
Case History: FFS bagging adds flexibility at feed plant
Case History: Conveyor dryers increase capacity, ensure quality at
Thai Luxe
A preview of new products on display at POWTECH 2008
POWTECH 2008 exhibitor list

DEPARTMENTS:

Industry news
Engineering literature: Bin Dischargers
Equipment feature: Bagging and Packaging
Equipment feature: Drying
Engineering literature: Rotary Airlocks
Product update
Supplier news
People news
Events
Advertiser index
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Pharmaceutical Engineering - July/August 2008

Table of Contents: Articles
Increased Process Understanding Through Monitoring and Scale-Down Models: Case Study of a Cell Culture Harvest Fluid Titration and Filtration Process
by Kurt Yanagimachi, Corey Dodge, and Marisa Hewitt
This article presents a case study demonstrating the use of detailed process monitoring and scale-down modeling in determining the root causes of yield losses in the manufacture of a therapeutic enzyme and identifying alternative technologies to improve the manufacturing process.
Case Study: Parenteral Facility Upgrade Project with Fill Line Install
by Keith Weseli and Michael DiGiovanni
This article presents a case study illustrating project management and commissioning and qualification processes that allowed for accelerated completion of a renovation project.
Integrating Industrial Engineering and Lean Techniques at a Contract Pharmaceutical Manufacturer
by Valerie Maier-Speredelozzi, Cyrus Agarabi, Thomas Needham, and Sirine A. Saleem
This article presents the application of industrial engineering and lean techniques to a contract pharmaceutical manufacturing facility.
Retrofitting CIP into API Plants
by Nigel A. Fletcher
This article describes the physical modifications and additions retrofitted into existing plants to incorporate CIP technology and some of the techniques that can be used to ‘stretch’ the existing CIP systems for best effect.
Solving the Terminology Conundrum
by Robert Adamson, Nuala Calnan, Robert E. Chew, and Steven J. Wisniewski
This article discusses the terms “commissioning,” “qualification,” and “verification.” Do the terms refer to the same or different ideas? How should the pharmaceutical and biotechnology industries use these terms in a consistent and meaningful way? This article provides a compilation of how these terms are used in regulations and by various industries, and provides a proposal for clear definitions to be used as ISPE updates and creates Baseline® Guides.

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Pharmaceutical Engineering - May/June 2008

Table of Contents
Articles

A Risk-Based Approach to Cleaning Validation using Visible Residue Limits
by Richard J. Forsyth and Jeffrey L. Hartman
This article describes the development of a Visible Residue Limits (VRL) program in a pharmaceutical manufacturing facility, including sample and viewing parameters. Opportunities for VRL implementation were identified in both pilot plant and manufacturing settings.
GAMP 5 Quality Risk Management Approach
by Kevin C. Martin and Dr. Arthur (Randy) Perez
This article describes how the GAMP 5 quality risk management strategy offers a pragmatic approach to computer systems compliance.
Creating Quality by Design/Process Analytical Technology (QbD/PAT) Management Awareness

by Christian Woelbeling and the Regional PAT COP from ISPE DACH Affiliate
This article summarizes the first four chapters of the PAT awareness document created by the PAT COP and explains how QbD/PAT management awareness can be created.
Industry Interview Series: Ruediger Dorn, Managing Director, Worldwide Pharmaceutical Industry, Microsoft
In this interview, Ruediger Dorn discusses Microsoft’s focus on the life sciences and the evolving relationship between plant operations and IT. Speaking from experience in auto manufacturing, he gives his thoughts on current challenges in the pharmaceutical industry.
Domain Methodology for Computer System Specification and Verification Applied to Manufacturing Execution Systems (MES)
by Joseph F. deSpautz and Gregory Ruklic
This article summarizes the domain methodology described in the GAMP® Good Practice Guide on Manufacturing Execution Systems currently under development.
Corrective Action Preventive Action (CAPA): A Risk Mitigating Quality System
by Gamal Amer
This article identifies ways to mitigate the risk associated with the manufacture of drug products.
On-line Exclusive Articles

Barrier Isolation History and Trends – 2006 Data
by Jack Lysfjord and Michael Porter
This article provides history and trends for automated fill finish for injectable drugs utilizing isolator technology.
GAMP 5 Debuts to a Record Breaking European Audience
by Gail Evans, ISPE Technical Documents Writer/Editor
Introduction to ICH: Essential Background to PQLI
by Dr. Kate E. McCormick, ISPE European Education Advisor
Global Regulatory News

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Controlled Environments May 2008


Controlled Environments - a monthly magazine focused on clean room requirements for aspectic/sterile pharmaceutical & microelectronics manufacturing detailing latest developments in the technology, vista on the scientific background and much more.

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