2nd Edition

Handbook of Pharmaceutical Manufacturing Formulations
Volume Three, Liquid Products



ISBN 9781138113794
Published February 26, 2018 by CRC Press
400 Pages 3 B/W Illustrations

USD $86.95

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Book Description

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

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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