ABSTRACT

In recent years there has been increased interest in the possibility of rapid microbiological methods offering enhanced potential error detection capabilities. However, these methods raise a number of questions, such as how to validate new methods, will they be accepted by the pharmacopoeias, and, most importantly, how will the regulators respond?

chapter 1|5 pages

Introduction

chapter 7|17 pages

Impedance

chapter 11|16 pages

Limulus Endotoxin Test

chapter 12|7 pages

A Practical Guide to Validation

chapter 13|8 pages

Regulatory Recognition and Acceptance

chapter 14|10 pages

New Technologies for Microbiological Assays