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.
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.
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.
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.
Guidance from ISPE's Investigational Medicinal Products Community of Practice
ISPE GAMP® Good Practice Guide: Global Information Systems Control and Compliance (Second Edition)
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...
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.
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