May / June 2020

Organization demographics of survey respondents; n = 25, with 20 unique organizations
Online Exclusives
Knowledge Management Implementation: A Survey of the Biopharmaceutical Industry
Knowledge management (KM) has been a recognized discipline for over 20 years in other industries, although within the biopharmaceutical industry, its discussion and formal implementation have been slow to gain momentum. The topic gained regulatory significance in 2008 when the ICH guidance document...
Happy Birthday, ISPE
InTouch
Happy Birthday, ISPE
Thank you to our Members for supporting ISPE and our mission to ensure the availability of quality medicines worldwide.
Good Engineering Practice in Risk-Based Commissioning & Qualification diagram
Technical
Good Engineering Practice in Risk-Based Commissioning & Qualification
Over the years, the roles and responsibilities of engineering and quality/validation personnel for commissioning and qualification (C&Q) activities have evolved. Now more than ever, commissioning and qualification approaches based on quality risk management (QRM) principles rely heavily on...
Brazil Affiliate
Insights
Benefiting from Growth Opportunities: ISPE Brazil Affiliate
Brazil’s regulatory authority is working hard to make the nation a larger player in the global pharmaceutical market, and these efforts appear to be working: the life sciences industry has expanded in recent years, and market projections are positive. These ongoing developments represent...
Wearable Devices & Biometrics Improving Efficiency in GxP Operations
Features
Wearable Devices & Biometrics Improving Efficiency in GxP Operations
As the old saying goes, “Time is money.” In today’s industrialized world, this adage is profoundly true. Manufacturers can no longer afford to overlook operational excellence. A new production philosophy called “Lean manufacturing” has been developed to save as much time as possible during...
Pam Cheng
Features
Industry Leaders: Mission-Driven Leadership
Pam Cheng is Executive Vice President, Global Operations & Information Technology, at AstraZeneca, a United Kingdom–headquartered pharmaceutical company with more than 60,000 employees. In this role, she combines her expertise as an engineer with business savvy and seeks opportunities to lead her...
A Gamp® Approach to Robotic Process Automation
Features
A GAMP® Approach to Robotic Process Automation
This article introduces the concept of robotic process automation (RPA) and discusses how the technology may be used within a GAMP® framework to support both non-GxP and GxP processes.
Regulators Address Innovations & Harmonization
Features
Regulators Address Innovations & Harmonization
At the 2019 ISPE Global Pharmaceutical Regulatory Summit, regulators updated attendees on approaches to industry innovations and the ongoing work on harmonization and reliance around the world.