Articles

Taking Responsibility for Supplier Purchasing Controls

How to establish clear guidelines, and stay out of trouble, courtesy of compliance consultants, a finished goods manufacturer, and a supplier.
Post Date: 09/13/2010
Author: Braulio Ortiz and Michael Neaves, BioTeknica Consulting

Contract Manufacturing: Orchestrating the Dance

Lean Six Sigma, expertise in microbiology, and shop-floor experience all contribute to running a flexible, efficient contract facility, says DPT’s new director of sterile ops.
Post Date: 08/03/2010
Author: Paul Thomas, Senior Editor

Lean Materials Management: Lessons from Lonza

How Lonza Biologics applied Lean to speed and improve materials processing in Hopkinton, Mass.
Post Date: 07/13/2010
Author: By Fred Greulich, Maxiom Group, and Jason Martin, Lonza Biologics Inc.

Outsourcing Excellence: A Catalyst for Sustainability

DSM Pharmaceutical Products has found that "going green" in its processes is easy to justify from a cost standpoint and gives it a competitive advantage.
Post Date: 05/11/2010
Author:

PharmaView: In India, Is Seeing Believing?

Can a whirlwind trip to India's pharma facilities prove skeptics wrong?
Post Date: 04/12/2010
Author: Paul Thomas, Senior Editor

Master Quality Agreements: Prepare for the Unpredictable

Contract partnerships inevitably have hiccups, and MQA's ensure they're dealt with quickly and systematically, says Pharmaceutics International's Alex McClung.
Post Date: 03/08/2010
Author: Paul Thomas, Senior Editor

Taking the Plunge to Harmonize Pharmaceutical Regulations

Within the past five years, more of world's regulatory agencies and pharmacopeias have gotten on the same wavelength.
Post Date: 03/04/2010
Author: Agnes Shanley, Editor in Chief

Webcast: Outsourced Manufacturing Strategies for Life Sciences: An Eli Lilly Case Study
Outsourcing affords life sciences manufacturers greater flexibility and market responsiveness, and the freedom to focus on core competencies. Outsourcing strategies, however, can vary widely. This webcast will provide an overview of trends and challenges influencing life science companies' outsourced manufacturing ...
Post Date: 02/25/2010
Author:

Putting Particulates on the Map

Contamination mapping isn’t exactly cartography, but it can be an effective troubleshooting tool.
Post Date: 01/06/2010
Author: Paul Thomas, Senior Editor

Novavax’s Robinson: Taking Vaccines to the World

Next Fall, Novavax expects to move to Phase III testing of its seasonal flu vaccine. In the meantime, it’s refining a manufacturing process that uses disposable process equipment to minimize risk, cost and plant footprint. VP Jim Robinson discusses the company’s plans.
Post Date: 12/02/2009
Author: Agnes Shanley, Editor in Chief

Flexible Pharma: Puzzling Out the Plant of the Future

The need to improve agility and reduce financial risk is driving new approaches to plant design and operation, and the use of new technologies. Industry experts look at the future pharmaceutical plant from all angles.
Post Date: 11/30/2009
Author: Agnes Shanley, Editor in Chief, with Paul Thomas, Senior Editor

Xcellerex’s Galliher: The Flexible Factory, Outsourced

Xcellerex offers companies a way to hedge the risk of building new drug facilities.
Post Date: 11/18/2009
Author:

Pushing Quality to Its Breaking Point

Texture analysis has become increasingly important for drug product quality, and is increasingly outsourced.
Post Date: 10/20/2009
Author:

Trust, Outsourcing’s Strategic Advantage

The ability to establish, build, and keep trust has become a strategic concern.
Post Date: 09/28/2009
Author: Kim Black-Washington, Director, Marketing & Strategic Development, Xcelience,...

Compliance Services: Searching for a Bit of Common Sense

enKap seeks to be a community of, by, and for compliance professionals. We talk with Glenn Melvin, and provide sage 21 CFR Part 11 advice.
Post Date: 09/15/2009
Author:

Five Steps to Success: How DPT Uses CAPA as a Hub for Quality Management

Corrective and Preventive Action (CAPA) management is vital to an organization's regulatory compliance initiatives. DPT Labs shares best practices from a recent implementation.
Post Date: 09/15/2009
Author: Ted Strawn, Quality Assurance Systems Analyst, DPT Laboratories

Patheon’s Lean Times

A talk with Paul Garofolo, Executive Vice President & Chief Technology Officer, about the Patheon Advantage Lean Six Sigma program.
Post Date: 07/21/2009
Author:

User-Driven HAPI Manufacturing at Metrics

A formulation development scientist, rather than an engineer, led the rollout of Metrics, Inc.’s new cytotoxic suite and the design of its flexible, but standardized isolator ports. Metrics’ director of potent pharmaceutical development Joe Cascone tells why, and what has resulted.
Post Date: 07/21/2009
Author: Paul Thomas, Senior Editor

Patheon Puts Its Money Where Its Mouth Is

Patheon’s metrics have improved to the point that it is incorporating on-time delivery guarantees and other new wrinkles into its contracts.
Post Date: 07/21/2009
Author: Paul Thomas, Senior Editor

Conquering a Continent: Nycomed Pioneers Foreign Drug Manufacturing in Russia

The Russian Government’s Reluctance to Enforce Manufacturing Standards Means Russian Consumers Turn to Foreign Pharmaceutical Brands They Trust
Post Date: 07/20/2009
Author: Gerhard Symons