13 Quality Assurance, Quality

Control and Audit

Rita Hattemer-Apostel

The aim of this chapter is to describe the general
framework for quality management (QM) in clin-
ical trials. Quality assurance (QA), including audits,
and quality control (QC) are components of QM,
and their contribution to quality and integrity of
clinical data is widely recognized, in particular, in
clinical research conducted according to good clin-
ical practice (GCP). As it is difficult to cover all
aspects of quality and auditing in one chapter, the
particular emphasis of this chapter is on approaches
to QM and general procedures for QA, QC and
audit. This should allow the readers to develop
QM systems for clinical trials which are tailored
to their specific environment and organization.

13.1 Introduction

QM is not a new discipline in industry, but the
concepts evolved and were refined over many dec-
ades and have been implemented in nearly all
areas, in manufacturing industries, service provi-
ders as well as nonprofit organizations. It, there-
fore, comes as no surprise that QM found its way
into pharmaceutical medicine, in particular, in
clinical research and GCP.
Research and development of pharmaceuticals
is a time-consuming and complex process,

demanding a good understanding of medical and

regulatory requirements paired with the ability to

manage sophisticated clinical trials which are often

to be conducted within an ambitious time schedule.

Competition is fierce and time-to-market often

dictates the ‘pulse’ of drug development. Over

the years, clinical studies have become increas-

ingly difficult because of heightened requirements

stipulated be regulatory agencies, development

and evolution of GCP guidelines and regulations

and technical advancements in data and document

management.

The need for outsourcing parts or even all drug

development activities to contract research organi-

zations (CROs) and specialized external providers

contributes to the complexity of developing new

pharmaceuticals.

Clinical research is a global business and multi-

national trials with globally dispersed investigator

sites are one sign of it. Local, national and interna-

tional requirements for conducting clinical studies

must be respected and, because of the variety of

countries and languages involved, familiarization

with those requirements is not always an easy

undertaking, but essential. And, to add to the

above, regulatory frameworks are subject to con-

tinuous refinement and revision. Monitoring of

these changes is mandatory and requires regular

Principles and Practice of Pharmaceutical Medicine, 2nd Edition Edited by L. D. Edwards, A. J. Fletcher, A. W. Fox and P. D. Stonier
#2007 John Wiley & Sons, Ltd ISBN: 978-0-470-09313-9