Following on from the release of our guide to using HPLC for the analysis of pharmaceuticals, Mourne Training Services is pleased to announce a guide for the validation of analytical methods. It is based on our popular training course Validation of Analytical Methods for Pharmaceutical Analysis, which deals with applying the available regulatory guidelines on method validation, such as ICH and FDA, to methods used for the chemical analysis of pharmaceuticals.
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 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 of the new guide include:
- Full review of the available regulatory guidelines on validation, 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 the validation characteristics specificity, linearity, range, accuracy, precision, detection limit, quantitation limit, robustness and 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 case study demonstrating how to plan a validation study, what to include in the protocol, which experiments to perform, how to set acceptance criteria and how to interpret the results and report the study.
Validation of Analytical Methods for Pharmaceutical Analysis by Oona McPolin is published by Mourne Training Services. It costs £29.90 and can be previewed and purchased on the Mourne Training Services website.