Buch, Englisch, 400 Seiten, Format (B × H): 228 mm x 287 mm, Gewicht: 2982 g
Volume Three, Liquid Products
Buch, Englisch, 400 Seiten, Format (B × H): 228 mm x 287 mm, Gewicht: 2982 g
ISBN: 978-1-4200-8123-7
Verlag: Taylor & Francis Inc
Highlights from Liquid Products, VolumeThree include:
practical details involved in complying with the current good manufacturing practice requirements in liquid manufacturing
access to what an FDA auditor would be looking for during a liquid manufacturing audit
issues that may arise during a US FDA inspection
the protocols used for stability testing for new drugs and new dosage forms, drawn from the most current ICH guidelines
Zielgruppe
Pharmaceutical manufacturers, and quality assurance and production personnel.
Autoren/Hrsg.
Fachgebiete
Weitere Infos & Material
REGULATORY AND MANUFACTURING GUIDANCEManufacturing Practice Considerations in Liquid FormulationsOral Solutions and Suspensions The FDA Drug Product Surveillance ProgramChanges to Approved NDAs and ANDAsFormulation Considerations of Liquid ProductsContainer Closure SystemsMaterial for ContainersStability Testing of New Drug Substances and ProductsStability Testing: Photostability Testing of New Drug Substances and ProductsStability Testing for New Dosage Forms Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and ProductsEvaluation of Stability DataStability Data Package for Registration Applications in Climatic Zones III and IVEU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary UseEDQM CertificationImpurities: Guideline for Residual SolventsElectronic Records and Signatures (CFR 21 Part 11 Compliance)GMP Audit Template, EU GuidelinesBioequivalence Testing Protocols Dissolution Testing of Liquid Dosage FormsApproved Excipients in Liquid FormsMANUFACTURING FORMULATIONSManufacturing Formulations