Delivering Training Solutions for Pharmaceutical Analysis
Mourne Training Services Ltd - Delivering training, consultancy and auditing services for pharmaceutical analysisAnalytical Method Validation training book for Pharmaceutical Analysis from Mourne Training Services (MTS)

Analytical Method Validation Book

Choose your location from the dropdown menu below (price includes shipping)

Shipping information

Postage and packing is FREE to UK and Ireland addresses and is very reasonably priced for other locations at only GBP £3.50 for Europe and GBP £5.50 for the rest of the world. Shipping times depend on your location but are typically less than 14 days from the date of the order.

Click on the book cover for a preview.

Click here for a preview of this book

Cost: GBP £29.00

Author: Oona McPolin

ISBN: 978-0-9561528-1-7

Format: Paperback, 210 x 300mm (A4), 152 pages

Publisher: Mourne Training Services


Methods which are used for the analysis of pharmaceuticals generate critical data and it is essential that the quality of this data is assured. Validation is required to demonstrate that these analytical methods are fit for their intended purpose. Validation data is also required by legislation, it is included in submissions to regulatory authorities all around the world for clinical trial and marketing applications. This book provides guidance on how to carry out a validation study for analytical methods.

Key features include:

Full review of the available regulatory guidelines on validation and in particular, those from the International Conference on Harmonisation (ICH). Sections of the guideline, Q2(R1), have been reproduced in this book with the kind permission of the ICH Secretariat.

Thorough discussion of each of the validation characteristics: Specificity; Linearity; Range; Accuracy; Precision; Detection Limit; Quantitation Limit; Robustness; System Suitability; plus practical tips on how they may be studied.

What to include in a validation protocol, with advice on the experimental procedure to follow and selection of appropriate acceptance criteria.

How to interpret and calculate the results of a validation study, including the use of suitable statistical calculations.

A fully explained case study demonstrating how to plan a validation study, what to include in the protocol, experiments to perform, setting acceptance criteria, interpretation of the results and reporting the study.

“A nicely written handbook on how to perform validation of methods used in pharmaceutical analysis.”

– Chemistry World, May 2010

Click here for a quotation if you would like to purchase multiple copies of the bookClick here for errata