Despite
much discussion about the subject over the past 3 years, in particular, data integrity
issues remain a common feature on 483 letters issued by the USA Food and Drug Administration
(FDA) and data handling matters are also a focus of enforcement actions (as
well as inspection findings from other regulatory agencies). It is perhaps for this
reason that the FDA has issued a new guidance document entitled Data Integrity and
Compliance with Drug cGMP: Questions and Answers – Guidance for Industry.
In
relation to this topic, Tim Sandle has written an article for GMP Review:
This
article reviews the new FDA data integrity guidance document and draws out some
items of interest for the pharmaceutical and healthcare sectors. The aim here
is not to overly repeat what is in the document (since the reader could and
should be doing this for themselves), but to note the differences between the
final document and the earlier draft and to draw out the key themes within the
document.
The
reference is:
For a copy, please contact Tim Sandle
Posted by Dr. Tim Sandle, Pharmaceutical Microbiology
Hi Tim.
ReplyDeleteCould I please be sent a copy of your article in GMP Review? tiffanyh@coriumintl.com
Thank you