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The Lead

The Path to Optimized Drug Production

August 14, 2014 8:36 am | by Nancy Berg, President and CEO of the International Society for Pharmaceutical Engineering (ISPE) | Blogs | Comments

Scaling up can be a challenge; know the processes and tools for a successful transition.                                              

ISPE Hires Healthcare Association Exec as CEO

July 29, 2014 3:47 pm | News | Comments

ISPE has hired John Bournas as President and CEO, succeeding Nancy Berg who announced plans to...

Processes for the Inspection of Cleaned Equipment in the Pharmaceutical Industry to Evolve

July 25, 2014 9:06 am | by The ISPE Cleaning Process Development and Validation Guide Task Team | Articles | Comments

When it comes to the inspection of cleaned equipment of pharmaceutical manufacturing equipment,...

Small Workstations, Large Benefits

April 30, 2014 3:06 pm | by Julie Ackerman, Senior Director PR and Communications, PMMI, The Association for Packaging and Processing Technologies | Blogs | Comments

Regardless of which stage a product is entering the pharmaceutical production line, keeping the...

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ISPE Announces Development of New Drug Shortages Prevention Plan for the Pharmaceutical Industry

April 28, 2014 11:03 am | News | Comments

ISPE, the International Society for Pharmaceutical Engineering, announced today that it will work with stakeholders world-wide to produce a Drug Shortages Prevention Plan to guide the pharmaceutical and biopharmaceutical industry in establishing reliable, robust and resilient supply chains that provide quality medicines to patients without interruption.

ISPE to Conduct Quality Metrics Pilot Program with FDA

March 13, 2014 11:36 am | News | Comments

ISPE will conduct the industry's first Quality Metrics Pilot Program designed to define and operationalize standard metrics reporting to the U.S. Food and Drug Administration.            

ISPE Announces Next Steps as Nancy Berg Completes Term as CEO

January 30, 2014 1:33 pm | News | Comments

ISPE announced today that CEO Nancy Berg will leave the Society when her three year contract is completed at the end of 2014.                    


All Signs Point to Pharma EXPO’s Successful Debut

October 18, 2013 10:39 am | News | Comments

PMMI, The Association for Packaging and Processing Technologies, reports a groundswell of positive response to Pharma EXPO 2014, which debuts in Chicago, co-located with PACK EXPO International 2014 (Nov. 2–5; McCormick Place). Pharma EXPO is a joint venture between PMMI, owner and producer of PACK EXPO International,  and the International Society for Pharmaceutical Engineering (ISPE).

ISPE Announces 2013-2014 Board of Directors Election Results

October 15, 2013 8:17 am | News | Comments

ISPE has announced the results of its 2013-2014 International Board of Directors election, revealing a slate of strategic leaders who represent a variety of pharmaceutical industry sectors. The Board will be responsible for the governance and strategic direction of the Society and will assume their elected positions at the 2013 ISPE Annual Meeting.

ISPE Announces Nancy Berg as New President and CEO Succeeding Bob Best

December 20, 2011 8:31 am | News | Comments

ISPE, the International Society for Pharmaceutical Engineering, today announced the appointment of Nancy S. Berg as President and CEO, effective 1 January 2012.

Supply Chain Security: A Comprehensive and Practical Approach

September 16, 2010 10:36 am | White Papers

Supply chain security is a chief concern throughout the pharmaceutical industry. ISPE's “Supply Chain Security: A Comprehensive and Practical Approach” illustrates how an integrated approach can help address pharmaceutical supply chain security concerns, such as preventing and detecting adulteration, counterfeiting, illegal diversion, and theft.

Former FDA Director Joins ISPE As Regulatory Affairs Advisor

January 8, 2010 5:10 am | News | Comments

ISPE, a global not-for-profit association of 24,000 technical professionals working in the manufacturing and drug development sectors of the pharmaceutical industry, has named Anthony Celeste as its North America Regulatory Affairs Advisor, effective immediately. In this role, Mr.


ISPE Announces 2009 Membership Award Winners at Global Annual Meeting

November 24, 2009 9:17 am | News | Comments

ISPE, a global not-for-profit association of 24,000 technical professionals working in the manufacturing and drug development sectors of the pharmaceutical industry, announced its 2009 award winners and recognized their contributions to the pharmaceutical industry and the Society. Robert P.

Roche Basel's MAB95 Facility Named 2009 Facility of the Year Award Overall Winner

November 9, 2009 7:13 am | News | Comments

ISPE, a global not-for-profit association of 24,000 technical professionals working in the

ISPE Announces 2009-2010 Board of Directors Election Results

October 8, 2009 10:46 am | News | Comments

ISPE, a global not-for-profit association of 24,000 pharmaceutical science and manufacturing professionals, has announced the results of its 2009-2010 International Board of Directors election, revealing a slate of representatives that hail from nearly every corner of the globe.

Excellence In A Small Space: Centocor Schaffhausen Creates An Advanced Fill Finish Pilot Plant Facility In A Tight Spot

June 8, 2009 7:52 am | Articles | Comments

Several years ago, after determining it would not have enough manufacturing capacity to meet the future needs of its growing pipeline, Centocor in Switzerland embarked on an ambitious plan to design and build a new vial and syringe filling facility at its Schaffhausen campus.

Laboratory Compliance: Making The Grade

June 1, 2009 11:13 am | Articles | Comments

What is "laboratory compliance"? It is a general term used by many people, but which means different things to different people. There is no definitive answer or even one in Wikipedia the "on-line" encyclopedia!


Elegantly Simple: Aseptic Technologies' process revolutionizes closed vial filling

May 7, 2009 11:53 am | Articles | Comments

In 2002 Aseptic Technologies saw the need to develop and launch a completely revolutionary way of manufacturing and filling closed vials. At the time of the facility's conception there was still much room for improvement of aseptic operations; as several accidents were being recorded each year due to injection of contaminated products.

Ultra-Fast Track Approach, Combined With An Integrated And Highly Motivated Project Team Leads To Award Recognition

September 16, 2008 11:41 am | Articles | Comments

F. Hoffman La Roche’s BioIV Facility Wins The 2008 Facility of the Year Award For Project Execution An ultra-fast track schedule in combination with a dedicated and highly experienced team of engineers has resulted in F.

Metrics VP Adds Pharm.D. To Professional Credentials

September 2, 2008 6:42 am | News | Comments

Dr. Michael D. Ruff, vice president of pharmaceutical development atMetrics Inc., has received his clinical doctor of pharmacy degree from the Shenandoah University Bernard J. Dunn College of Pharmacy. Ruff completed his Pharm.D.

Innovative Facilities Invited to Submit for 2009 Facility of the Year Awards

August 18, 2008 12:48 pm | News | Comments

ISPE, together with INTERPHEX and Pharmaceutical Processing magazine — have announced a call for global pharmaceutical manufacturing organizations to submit details of newly constructed or renovated facilities for the 2009 Facility of the Year Awards (FOYA) program.

Use of Disposables in Final Filling Operations Converting to disposable filling components can result in significant benefits - no matter what product you are processing

August 5, 2008 6:00 am | Articles | Comments

Single use technology continues to gain popularity in pharmaceutical and biopharmaceutical operations. One area where single use technology would be very beneficial is in product final filling.

Reed Exhibitions And ISPE Announce Partnership In Canada

April 2, 2008 12:47 pm | News | Comments

Reed Exhibitions, a leading organizer of trade and consumer events and producers of the global INTERPHEX brand, is partnering with the ISPE, the world’s largest not-for-profit society serving pharmaceutical manufacturing professionals, to create INTERPHEX Canada.

ISPE and AAPS Host Life Sciences Job Fair During INTERPHEX2008

March 24, 2008 5:08 am | News | Comments

ISPE and the American Association of Pharmaceutical Scientists (AAPS) are hosting the second annual Life Sciences Job Fair at INTERPHEX2008, in collaboration with Reed Exhibitions.

Qualifying Vendors of HVAC Environmental Control Solutions

March 11, 2008 10:35 am | Articles | Comments

How to carefully select suppliers for validating automation products and supporting services By Walfried Laibacher HBS EMEA Validation Services Lead To maximize the market life of a patented drug, pharmaceutical companies must quickly move products from conception to market.

2008 Facility of the Year Awards (FOYA) Winners Announced

February 6, 2008 10:15 am | News | Comments

Five pharmaceutical manufacturing facilities constructed by companies located in Germany, Switzerland, and the United States have been selected as Category Winners in the fourth annual Facility of the Year Awards program sponsored by ISPE, INTERPHEX, and Pharmaceutical Processing magazine.

Vetter’s New RVS Facility Targets Outsized Growth in Aseptic Prefilled Administration Devices

October 9, 2007 11:11 am | Articles | Comments

New plant maximizes automation while increasing both capacity and capability in manufacturing Automation to the maximum was uppermost on the drawing boards at Vetter Pharma-Fertigung GmbH & Co.

Constant Kaizen Delivers Major Win for Taiyo Yakuhin

September 4, 2007 12:21 pm | Articles | Comments

First to make and fill glass syringes in-house, Taiyo's success recognized with Facility of the Year Award Major Process Equipment Suppliers Primary Works Plastic Forming Line Daiichi Jitsugyou K.K. Preparation System Itochu Foodec K.K./Clean Mechanical K.K.

Cook Pharmica Targets Growing Outsourcing in Biopharmaceutical Industry

August 7, 2007 7:14 am | Articles | Comments

Goal to deliver innovative analytical, development and manufacturing services with an emphasis on

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