iSpeak Blog

February 25, 2014
Co Authors: Eric Bohn, AIA, and Magdalena Nogalski Krapf AIA, LEED AP BD+C with Jacobs Wyper Architects ( website | LinkedIn ) Managers of legacy pharmaceutical manufacturing facilities continually struggle against aging infrastructure, improvements...
February 14, 2014
By Wendy Haines, PhD and Lindsay Jewett Have you read Roger Nosal’s article in the latest edition of Pharmaceutical Engineering ? If you’ve even glanced through your copy, you probably couldn’t help but notice it – it was the article whose headline c...
February 13, 2014
The submissions are in. The judges are preparing to meet. That can only mean one thing: the 2014 Facility of the Year Awards (FOYA) Category Winners will soon be announced, kicking off our year-long celebration of industry’s dedication to excellence...
January 29, 2014
By Mark von Stwolinski The first edition of the ISPE Biopharmaceutical Manufacturing Facilities Baseline Guide was issued in June 2004. Its concepts have been phased-in over the past several years. Since 2004, the Industry, processing technology and...
January 22, 2014
How do you build the quality that is essential to all processes and products? Training auditors to conduct good audits is one way. These are some critical skills auditors must know to conduct successful audits: Using audit trails and checklists to pr...
January 16, 2014
This post is another a series of reports on the many regulatory-related activities your fellow ISPE Members are undertaking, and how you can add your voice to these impactful initiatives. Members Represent ISPE at Prestigious EMA Events Presentation...
January 09, 2014
by Nissan Cohen Rouge development due to the usage of high temperature water in piping and vessels is a continuing issue in the pharmaceutical industry. Many SOPs and directives are developed and instituted at individual biopharmaceutical and traditi...
December 13, 2013
Our Member Spotlight is Francois Sallans, Vice President and Chief Quality Officer for Johnson & Johnson (Janssen) in Belgium. In this role, he is responsible for the quality and compliance activities in J&J Pharma's sector, including supply chain qu...
November 15, 2013
It’s hard to believe an entire week has gone by since the conclusion of the 2013 ISPE Annual Meeting. The event was incredibly powerful, bringing together over 1,600 industry and regulatory attendees to discuss some of pharma’s biggest challenges and...
November 15, 2013
Complete separation of process and products from each other within a biopharmaceutical manufacturing facility is an operational and regulatory imperative. But does that necessarily mean physical separation? Or can separation be achieved in common spa...