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.
Table of Contents
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.
". . .a valuable compilation of the current situation in regulatory issues as well as some of the technical problems associated with parenteral drug production. "