Good Manufacturing Practices for Pharmaceuticals

Offering a wide assortment of illustrative examples and 483 expert observations, this Sixth Edition is significantly expanded to reflect the explosion of information and changing practices in cGMP regulation and pharmaceutical manufacturing and control. An essential companion for every pharmaceutical professional, this guide supplies new and must-have information on system audits, electronic records and signatures, PAT applications, failure investigations, FDA enforcement tools, global regulatory changes, contracting and outsourcing, and the latest FDA guidance documents.