With over twenty different official regulatory statements worldwide on Good Manufacturing Practice (GMP) for pharmaceutical, drug, or medicinal products, two stand out as being the most influential and most frequently referenced.
Bridging the gap between U.S. regulations and European Good Manufacturing Practice guidelines, Good Pharmaceuti
Auflage
Sprache
Verlagsort
Verlagsgruppe
Zielgruppe
Für höhere Schule und Studium
Manufacturing and QA personnel, compliance personnel, Pharmaceutical consultants, and drug developers
Illustrationen
39 s/w Abbildungen, 18 s/w Tabellen
39 b/w images and 18 tables
Dateigröße
ISBN-13
978-0-203-48911-6 (9780203489116)
Copyright in bibliographic data and cover images is held by Nielsen Book Services Limited or by the publishers or by their respective licensors: all rights reserved.
Schweitzer Klassifikation
Introduction - StatU.S. and Applicability of U.S. Regulations/E.U. Guidelines - General Quality Issues Personnel, Organization and Training Premises/Buildings and Facilities Contamination and Contamination Control Equipment Materials Control Production and Process Controls Packaging and Labelling Control Holding and Distribution Laboratory Controls Records and Reports Returned and Salvaged Products Sterile Products Other GMP Issues
