Global Regulations and Inspections - Research Quality Assurance

Table of Contents

Table of  Contents  3

  Abbreviations  4

1  Coursework Assignment Section 4 Global Regulations and Inspections  5

2  Selection of Title  5

3  Introduction  6

4  Purpose of government inspections for GCP  6

5  Preparation programme for inspections  7

5.1  Permanent preparation programme for inspections  7

5.2  Specifics for preparation prior to an announced inspection  7

5.3  Specifics to immediate preparation for an for cause inspection  8

6  Improvements  9

7  Summary  10

8  References  11

  MSc Quality Management (RSR D) Page 3 of  11

Abbreviations

BfArM Bundesinstitut für Arzneimittel und Medizinprodukte

(German Regulatory Authority)

CRO Clinical Research Organisation

EMEA European Medicines Agency

EU European Union

FDA Food and Drug Administration

GCP Good Clinical Practice

GXP Good Clinical/Manufacturing/Laboratory Practice

ICH International Conference on Harmonisation

MHRA The Medicines and Healthcare products Regulatory Agency

QA Quality Assurance

QC Quality Control

QM Quality Management

SOP Standard Operating Procedure

UK United Kingdom

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1 Coursework Assignment / Section 4 Global Regulations and Inspections

Choice of one from two titles

Ø Discuss the purpose of government inspection for one of the GXPs. Describe your/an organisation’s preparation programme for such inspection and propose improvements in line with current expectations.

Ø Has global harmonisation of Regulations contributed to efficient management of the audit process in your particular organisation? Discuss.

2 Selection of Title

The first title was chosen:

Ø Discuss the purpose of government inspection for one of the GXPs. Describe your/an organisation’s preparation programme for such inspection and propose improvements in line with current expectations.

The issue was discussed on the basis of Good Clinical Practice (GCP) with special focus on a Clinical Research Organisation (CRO).

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