Overview

While liquid drugs do not share the compression problems of solid dosage forms, the filling problems of powder dosage forms, or the consistency problems of semisolid dosage forms, they do have their own set of considerations in the formulation and manufacturing stages. Highlights from Liquid Products, Volume Three 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

Full Product Details

Author:   Sarfaraz K. Niazi (Pharmaceutical Scientist Inc., Deerfield, Illinois, USA)
Publisher:   Taylor & Francis Inc
Imprint:   Informa Healthcare
Edition:   2nd New edition
Dimensions:   Width: 21.60cm , Height: 3.00cm , Length: 27.90cm
Weight:   1.452kg
ISBN:  

9781420081237

ISBN 10:   1420081233
Pages:   400
Publication Date:   01 September 2009
Audience:   Professional and scholarly ,  Professional & Vocational ,  Professional & Vocational
Replaced By:   9781138103221
Format:   Hardback
Publisher's Status:   Out of Stock Indefinitely
Availability:   Out of stock  

Table of Contents

REGULATORY AND MANUFACTURING GUIDANCE Manufacturing Practice Considerations in Liquid Formulations Oral Solutions and Suspensions The FDA Drug Product Surveillance Program Changes to Approved NDAs and ANDAs Formulation Considerations of Liquid Products Container Closure Systems Material for Containers Stability Testing of New Drug Substances and Products Stability Testing: Photostability Testing of New Drug Substances and Products Stability Testing for New Dosage Forms Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products Evaluation of Stability Data Stability Data Package for Registration Applications in Climatic Zones III and IV EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use EDQM Certification Impurities: Guideline for Residual Solvents Electronic Records and Signatures (CFR 21 Part 11 Compliance) GMP Audit Template, EU Guidelines Bioequivalence Testing Protocols Dissolution Testing of Liquid Dosage Forms Approved Excipients in Liquid Forms MANUFACTURING FORMULATIONS Manufacturing Formulations

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