Pharmaceutical Dosage Forms Parenteral Medications

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.

Completely updated and enlarged to three volumes (originally published as two volumes), the Second Edition of Pharmaceutical Dosage Forms: Parenteral Medications examines every important aspect of sterile drug products. This volume (3) offers comprehensive coverage of medical devices, quality assurance and regulatory issues.;This in-depth reference and text: discusses regulatory requirements in record-keeping based on the US Food and Drug Administration's (FDA) Current Good Manufacturing Practices; places special emphasis on methods of detecting, counting and sizing particles; offers new perspectives on contemporary validation concepts and how they affect the validation process; explains current FDA enforcement activities, the voluntary compliance policy, select court cases, and how these relate to parenterals; provides recent materials on the use of audits as a means of verifying the efficacy of manufacturing control systems; highlights new US regulations for medical devices; and examines quality assurance, including new information on biological control tests for medical device materials.;With the contributions of leading experts, volume 3 of Pharmaceutical Dosage Forms: Parenteral Medications is intended as a day-to-day reference for pharmacists, medical device manufacturers, quality control and regulatory personnel, chemists and drug patent and litigation attorneys, as well as a text for upper-level undergraduate, graduate and continuing-education students in the pharmaceutical sciences.

Quality assurance, Samir A. Hanna; records and reports, David C. Fry and Karl L. Hofmann; particulate matter, Patrick P. DeLuca and Julius Z. Knapp; validation of sterilization processes and sterile products, James Agalloco and James Akers; federal regulation of parenterals, Jonas L. Bassen et al; systematic audits of parenteral drug good manufacturing practices, Ronald F. Tetzlaff; medical devices - design, manufacture, and quality control, David H. Wayt; quality assurance for medical devices, Carl W. Bruch; regulatory and GMP considerations for medical devices, Larry R. Pilot.