Guidance for Industry
Errors and Accidents Regarding Saline Dilution of Samples Used for Viral Marker Testing
[PDF version of this document]
Comments and suggestions regarding this document may be submitted
at anytime to Stephen Ripley, Center for Biologics Evaluation and
Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike,
Rockville, MD 20852-1448. For questions regarding this document,
contact Sharon O'Callaghan, CBER, Office of Compliance and Biologics
Quality, Division of Inspections and Surveillance
(HFM-650), (301) 827-6220.
Additional copies are available from the Office of Communication,
Training and Manufacturers Assistance (HFM-40), 1401 Rockville Pike
Rockville, MD 20852-1448, or by calling 1-800-835-4709 or 301-827-1800,
or from the Internet at http://www.fda.gov/cber/guidelines.htm
U. S. Department of Health and Human Services
Food and Drug Administration
Center for Biologics Evaluation and Research (CBER)
June 1998
Guidance for Industry1
Errors and Accidents Regarding Saline Dilution of Samples Used
for Viral Marker Testing
Inspections by Food and Drug Administration (FDA) personnel have
identified instances in which the integrity of samples intended to
be used for viral marker testing has been compromised by saline during
collection of blood and blood components with automated pheresis
instruments when the saline reinfusion protocol was utilized. FDA
has noted instances where samples for testing were diluted by saline
as a result of three separate problems. These problems involved
inadvertent keypad entries that caused the tubing to be rinsed with
saline during sample collection, improper installation of tubing
into a valve clamp, or failure to clamp the saline line that caused
saline to be added to the collection bag during collection. The use
of saline diluted samples is potentially significant in that it could
contribute to obtaining false negative results for viral marker
testing, and result in the transfusion or further manufacture of
potentially infectious blood and blood products.
Title 21, Code of Federal Regulations, Section 600.14(a), states
that the Director, Office of Compliance and Biologics Quality
(formerly Office of Compliance), Center for Biologics Evaluation
and Research (CBER), shall be promptly notified of errors or accidents
in the manufacture of biological products that may affect the safety,
purity, or potency of the product. Additional guidance was issued to
blood establishments by memorandum dated March 20, 1991, advising
that notification is necessary when the unsuitable product has been
distributed or made available for distribution.
Any unexplained discrepancy or failure of a unit, lot, or batch to
meet any of its specifications shall be thoroughly investigated,
including identification of associated products that may also be
affected, regardless of whether or not product was distributed.
A written record of the investigation must be made including the
conclusions and follow-up (See 21 CFR 606.100(c), 606.160(b)(7)(iii),
211.192, and 211.198).
CBER is issuing this document to notify blood and plasma
establishments that saline dilution of samples intended for viral
marker testing should be reported as an error or accident if the
products are made available for distribution or the product has
been distributed. In this context, available for distribution
means that the blood product/component has been determined to
meet all release criteria and is being held for distribution, and
that no additional review of release criteria will be performed.
Questions concerning errors and accidents in the manufacture of
biological products should be directed to Sharon O'Callaghan, CBER,
Office of Compliance and Biologics Quality, Division of Inspections
and Surveillance (HFM-650) at (301) 827-6220.
1
This guidance document represents the Agency's current thinking on
the need for reporting errors and accidents related to saline dilution
of samples used for the viral marker testing of blood and blood
components. It does not create or confer any rights for or on any
person and does not operate to bind FDA or the public. An alternate
approach may be used if such approach satisfies the requirements of
the applicable statute, regulations, or both.
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