AAMI GMP1.5

Completely revised for meeting today's FDA GMP and other international quality system requirements. This timesaving guide leads you step-by-step through documenting, implementing, and directing quality systems from design concept through purchasing, manufacturing, inspection and testing, distributing, installing, and servicing according to current regulatory and legal requirements. Includes FDA's new GMP Quality System regulation and copies of official guidance documents to manufacturers, distributors, service organizations, and FDA inspectors. William Cotliar, PE, and Lawrence Bauer, PhD, are fellows of the American Society for Quality Control and have served as examiners on the Malcolm Baldrige National Quality Awards.