ABSTRACT

Written by twenty-eight experts, filled with recommendations that can immediately be put into action, this book provides the strategies and tactics required to link and harmonize manufacturing processes with GMP to achieve optimum operability and cost-effective regulatory compliance. Drawn from name brand and generic companies and regulatory and co

chapter 6|28 pages

LABORATORY OPERATIONS: A VITAL LINK

chapter 7|24 pages

VALIDATION: WHERE ARE THE OPPORTUNITIES?

chapter 11|36 pages

PAI PREPARATION: PRESCRIPTION FOR SUCCESS