Foreward
To say that the pharmaceutical industry is globalized as never before is an understatement. Through partnerships, outsourcing relationships and as a result of economic pressure, the industry now faces unprecedented challenges, not the least of which is how to maintain quality standards and balance different regulatory requirements in today’s globally diversified manufacturing environment.
In this book, Jim Vesper consolidates and correlates the key references from the most important global GMP standards into a cohesive and readable reference. He clearly distinguishes between requirements and expectations across the different standards – US, European, Canadian, World Health Organization and International Conference on Harmonization – and makes both the scientific and business case for a unified global approach to compliance and quality management.
The result is a reference that contains something worthwhile for everyone, from the student of basic GMP principles to the most senior management personnel.
Jim is to be commended for this contribution to the body of GMP knowledge. I am certain readers will find it to be among the most valuable learning and reference tools currently available in GMP literature.
David L. Chesney
Vice President and Practice Lead,
Strategic Compliance Services,
PAREXEL Consulting
Waltham, Massachusetts