iSpeak Blog

July 13, 2017
On 15 June, ISPE announced the release of their latest publication, ISPE Good Practice Guide: Decommissioning of Pharmaceutical Equipment and Facilities . The Guide is intended to be a “one-stop-shop” for information to be used for decommissioning an...
July 12, 2017
This article presents a consensus standardized extractables testing protocol for single-use systems in biomanufacturing This article was originally published in the November – December 2014 issue of Pharmaceutical Engineering® magazine . Click here f...
July 11, 2017
ISPE Foundation The ISPE International Board of Directors has approved the establishment of an ISPE Foundation. We are currently filing associated legal documents and finalizing the organizational structure for the foundation. We expect these efforts...
July 06, 2017
It’s time for another edition of Reading Roundup featuring the top blog posts of June 2017. Start off your week by catching up on what the pharmaceutical industry was reading in June. Extractables and Leachables: Not the Same – Part 2 As a follow-up...
July 05, 2017
Interactive Discussion on Drug Shortages Prevention François Sallans, Vice President, Quality and Compliance, Chief Quality Officer, Johnson & Johnson, and Chair of the ISPE Drug Shortages Initiative , led the featured session “ Interactive Discussio...
June 27, 2017
Participants gathered for the Women in Pharma (WIP) breakfast on day 2 of the 2017 ISPE/FDA/PQRI Quality Manufacturing Conference , held 5-7 June 2017. Women in Pharma Chair Fran Zipp, President and CEO, Lachman Consultants and ISPE Board member , we...
June 26, 2017
Proactive Approaches to Facility and Life Cycle Quality Management Workshop Jim McGlade, Science Client Leader for BHDP Architecture, led the “Proactive Approaches to Facility and Lifecycle Quality Management” Workshop. “What’s an architect doing in...
June 21, 2017
This article was published in the May-June 2017 edition of Pharmaceutical Engineering ® magazine . Megan was diagnosed with Type 1 diabetes in 2007 when she was five months pregnant with her first child. She began the routine, familiar to many of the...
June 21, 2017
It’s time for another edition of Reading Roundup featuring the top blog posts of May 2017. Start off your week by catching up on what the pharmaceutical industry was reading in May. Celebrate 8 Companies Who Are Advancing Pharmaceutical Manufacturing...
June 20, 2017
Clinically Relevant Specifications (CRS) are a set of criteria and acceptance ranges—such as impurities, dissolution, and in vitro release testing—to which drug products should conform to deliver their therapeutic benefits. Questions remain on establ...