Accreditation and Quality Assurance

, Volume 9, Issue 8, pp 503–506

Method validation and qualification of instruments for atomic spectrometry

Implementation of good manufacturing practice (GMP)—requirements for practical work
Practitioner’s Report

DOI: 10.1007/s00769-004-0784-3

Cite this article as:
Pohl, B. Accred Qual Assur (2004) 9: 503. doi:10.1007/s00769-004-0784-3

Abstract

This work describes the analytical procedures for atomic absorption and inductively coupled plasma (ICP) techniques that have to be used in order to obtain a license to sell drugs in the USA. The qualification of atomic absorption spectrometers and ICP instruments is described. The method validation characteristics, e.g., accuracy, precision, linearity, range, detection limits, and quantification are discussed. The time involved and the quality of documentation are pointed out. The consequences for laboratory personnel and operating costs are also discussed.

Copyright information

© Springer-Verlag 2004

Authors and Affiliations

  1. 1.WeiterstadtGermany