Pharmaceutical Dosage Forms: Parenteral Medications, Volume 3

Completely updated and enlarged to three volumes, the second edition of Pharmaceutical Dosage Forms: Parenteral Medications examines every important aspect of sterile drug products. Volume 3 offers comprehensive coverage of medical devices, quality assurance, and regulatory issues. It discusses regulatory requirements in record-keeping, places special emphasis on methods of detecting, counting and sizing particles, and offers new perspectives on contemporary validation concepts and how they affect the validation process. It also explains current FDA enforcement activities, the voluntary compliance policy, select court cases, and how these relate to parenterals.