Method Validation in Pharmaceutical Analysis : A Guide to Best Practice

✍ Scribed by Joachim Ermer (Editor), John H. McB. Miller (Editor)

Year: 2005
Tongue: English
Leaves: 411
Edition: 1
Category: Library

No coin nor oath required. For personal study only.

✦ Synopsis

Adopting a practical approach, the authors provide a detailed interpretation of the existing regulations (GMP, ICH), while also discussing the appropriate calculations, parameters and tests. The book thus allows readers to validate the analysis of pharmaceutical compounds while complying with both the regulations as well as the industry demands for robustness and cost effectiveness.Following an introduction to the basic parameters and tests in pharmaceutical validation, including specificity, linearity, range, precision, accuracy, detection and quantitation limits, the text focuses on a life-cycle approach to validation and the integration of validation into the whole analytical quality assurance system. The whole is rounded off with a look at future trends.With its first-hand knowledge of the industry as well as regulating bodies, this is an invaluable reference for analytical chemists, the pharmaceutical industry, pharmaceutists, QA officers, and public authorities.

📜 SIMILAR VOLUMES

Method validation in pharmaceutical anal

📁 Method validation in pharmaceutical analysis : a guide to best practice

✍ Joachim Ermer; John H McB Miller 📂 Library 📅 2005 🏛 Wiley-VCH 🌐 English

Method Validation in Pharmaceutical Anal

📁 Method Validation in Pharmaceutical Analysis: A Guide to Best Practice

✍ Joachim Ermer, Phil W. Nethercote 📂 Library 📅 2014 🏛 Wiley-VCH 🌐 English

This second edition of a global best-seller has been completely redesigned and extensively rewritten to take into account the new Quality by Design (QbD) concept in pharmaceutical manufacturing. <br>As in the first edition, the analytical requirements during the entire product lifecycle are covered,

Validating chromatographic methods : a p

📁 Validating chromatographic methods : a practical guide

✍ David M Bliesner 📂 Library 📅 2006 🏛 Wiley 🌐 English

Validating Chromatographic Methods: A Pr

📁 Validating Chromatographic Methods: A Practical Guide

✍ David M. Bliesner 📂 Library 📅 2006 🏛 Wiley-Interscience 🌐 English

All the information and tools needed to set up a successful method validation systemValidating Chromatographic Methods brings order and Current Good Manufacturing Practices to the often chaotic process of chromatographic method validation. It provides readers with both the practical information and

The Design Analysis Handbook: A Practica

📁 The Design Analysis Handbook: A Practical Guide to Design Validation

✍ N. Edward Walker 📂 Library 📅 1998 🌐 English

"...A book that should be on the shelf of every digital or analog electronic-system designer." - Frank Goodenough, Electronic DesignThis Handbook offers design engineers and managers immediately useful, meat-and-potatoes techniques for achieving design validation by analysis in an easy-to-read style

The Design Analysis Handbook A Practical

📁 The Design Analysis Handbook A Practical Guide to Design Validation

✍ N. Edward Walker 📂 Library 📅 1998 🏛 Newnes 🌐 English

"...A book that should be on the shelf of every digital or analog electronic-system designer." - Frank Goodenough, Electronic Design This Handbook offers design engineers and managers immediately useful, meat-and-potatoes techniques for achieving design validation by analysis in an easy-to-read styl