A Path to Quality

Compliance with quality regulations that protect patients' safety is a critical requirement for the pharmaceutical industry. Regulatory compliance goes a long way toward proving that a given product's target for quality has been achieved and documented. Pharmaceutical Manufacturing Handbook: Regulations and Quality is intended to help readers understand how to comply with regulations and how to adapt a quality unit's routine activities to facilitate compliance.

In the book's preface, editor Shayne Cox Gad says the book describes "all regulatory aspects and requirements that govern how drugs are produced for evaluation (and, later, sale to and use) in humans." The book's back cover says it contains "everything you need to ensure full compliance and superior quality control."

The book's eight sections cover topics such as good manufacturing practices (GMPs) and other US Food and Drug Administration guidelines, international GMP regulations, quality, process analytical technology (PAT), personnel, contamination and contamination control, drug stability, and validation.