Handbook of Pharmaceutical Manufacturing Formulations: Volume Three, Liquid Products, 2nd Edition (Paperback) book cover

Handbook of Pharmaceutical Manufacturing Formulations

Volume Three, Liquid Products, 2nd Edition

By Sarfaraz K. Niazi

CRC Press

400 pages | 3 B/W Illus.

Purchasing Options:$ = USD
Paperback: 9781138113794
pub: 2018-02-26
$79.95
x
Hardback: 9781420081237
pub: 2009-09-21
$220.00
x
eBook (VitalSource) : 9780429145766
pub: 2016-04-19
from $39.98


FREE Standard Shipping!

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

Subject Categories

BISAC Subject Codes/Headings:
MED071000
MEDICAL / Pharmacology