|
CPS
Master File
The purpose
of the CPS Master File is to describe the critical procedures, policies,
and systems related to the facility, operations, and quality
management of the DTM Cell Processing Section (CPS). The information
contained in the Master File serves as a summary that can be cross-referenced
by NIH investigators and other parties submitting Investigational
New Drug (IND) applications that involve products manufactured by
CPS.
This PDF is
a controlled document and represents the current version on file
at the U.S.Food and Drug Administration (FDA). It can not be copied
or printed. Questions, comments or concerns about this Master File
may be addressed to:
J. Wade Atkins
Quality Assurance Officer
National Institutes of Health
Clinical Center, Department of Transfusion Medicine
10 Center Drive
Bldg. 10/Rm. 1C-711 (MSC 1184)
Bethesda, MD 20892-1184
301-402-1704
-or-
Wade Atkins (jatkins@mail.cc.nih.gov)
By selecting
the Accept option below, I agree to not re-distribute this
document. By selecting Decline, I understand that I will
be returned to
the CPS homepage and will not be allowed to view the document.
I Accept the condition above
I Decline the condition above
|