Features
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Compliance Challenges for a Global Industry
Cover: Amid the great opportunities that flow from extending their networks of facilities around the globe, pharmaceutical manufacturers are facing compliance challenges in emerging markets—especially culturally distinct ideas about safety, risk, and quality.
The Growing Influence of PIC/S in Asia Pacific
Feature: The Asia Pacific region contains 60% of the world’s population and is the fastest growing region in the world. Of the 24 countries in the region, 19 are being influenced in some way by PIC/S in their regulation of medicine manufacturers.
Sustainability
Special Report: This issue’s special report explores sustainability in the life sciences industry, cleanliness classifications for life science facilities, and the origins of 90 fpm as the standard for cleanroom airflow.
In This Issue
InTouch
There is still a lot of uncertainty on how to effectively structure a corporate data integrity program. It starts with the definition of the scope and often it ends with parallel work between departments who are owners of different systems along the value chain.
Technical
Guidance from ISPE's Investigational Medicinal Products Community of Practice
InTouch
ISPE GAMP® Good Practice Guide: Global Information Systems Control and Compliance (Second Edition)
Features
The Asia Pacific region, which comprises 24 culturally diverse countries, contains 60% of the world's population and is the fastest growing region in the world today
This article describes the growing influence of Pharmaceutical Inspection Co-operation Scheme (PIC/S) in the Asia Pacific region. Of the 24 countries in the Asia Pacific region, 19 are being influenced in some way by...
Technical
What is cleaning validation and where does it fall in the life cycle validation scheme? How can an automated washing system be validated? This article provides insights that may help answer these questions.
InTouch
Hi David, I am trying to make a career change. I want to move into a different area of engineering, and I am not having any luck. How can I be more effective?
