Establishing A CGMP Laboratory Audit System (eBook)

The first systematic, hands-on auditing guide for today's
pharmaceutical laboratories

In today's litigious environment, pharmaceutical laboratories are
subject to ever stricter operational guidelines as mandated by the
FDA, and must be able to establish and demonstrate sustainable
operational practices that ensure compliance with the current good
manufacturing practice (CGMP) regulations. David Bliesner's
Establishing a CGMP Laboratory Audit System: A Practical Guide is
designed to provide laboratory supervisors and personnel with a
step-by-step, hands-on audit system that they can rely on to ensure
their facility remains compliant with all current and future
requirements. Focusing on a "team approach," the author uses
detailed flowcharts, checklists, and descriptions of the auditing
process to help readers develop a new audit system or upgrade their
current system in order to:

* Improve current compliance

* Demonstrate sustainable compliance

* Produce data for federal inspections

* Avoid regulatory action

Enhanced with detailed checklists and a wealth of practical and
flexible auditing tools on CD-ROM, this book provides an ideal
resource for new and future laboratory personnel, and an excellent
means for keeping existing industry practitioners up to date on the
nuances of operating a consistently compliant pharmaceutical
laboratory.