Views expressed in this paper are those of the author and are not necessarily endorsed by his employer.
A qualitative examination of FDA warning letters - what can we learn from GCP inspections?
Article first published online: 6 AUG 2002
Copyright © 2002 John Wiley & Sons, Ltd.
The Quality Assurance Journal
Volume 6, Issue 3, pages 143–157, September 2002
How to Cite
Wilsher, C. R. (2002), A qualitative examination of FDA warning letters - what can we learn from GCP inspections?. Qual. Assur. J., 6: 143–157. doi: 10.1002/qaj.186
- Issue published online: 6 AUG 2002
- Article first published online: 6 AUG 2002
- warning letters
Good clinical practice (GCP) inspections are now a global reality and it may be timely to review the outcome of the largest set of detailed information (warning letters) from the foremost GCP inspectors (the Food and Drug Administration (FDA). Looking at qualitative information, it provides us with a detailed insight into the workings of GCP inspections. From this information, we can learn what ‘pitfalls’ to avoid and how to pro-actively build safeguards to prevent future problems. This review particularly highlights the fact that FDA inspectors do not limit themselves solely to traditional clinical records when verifying submitted data. Locating these ‘other’ sources and ensuring consistency is vital to pre-inspection readiness. Sponsors, CROs and investigators must ensure that adequate procedures are in place and that staff are well trained on these procedures. Copyright © 2002 John Wiley & Sons, Ltd.