[Federal Register Volume 60, Number 135 (Friday, July 14, 1995)]
[Notices]
[Pages 36290-36291]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-17346]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 91N-0450]
Guideline for Quality Assurance in Blood Establishments;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guideline entitled ``Guideline for Quality Assurance
in Blood Establishments.'' This guideline is intended to assist
manufacturers of blood and blood components, including blood banks,
blood centers, transfusion services, and plasmapheresis centers, in
developing quality assurance (QA) programs that are consistent with
recognized principles of QA and current good manufacturing practice
(CGMP). This guideline revises the draft ``Guideline for Quality
Assurance in Blood Establishments,'' dated June 17, 1993, and provides
general information on procedures and practices that may be useful to
blood establishments in developing and administering a QA program.
DATES: Written comments may be submitted at any time.
ADDRESSES: Submit written requests for single copies of the ``Guideline
for Quality Assurance in Blood Establishments'' to the Congressional
and Consumer Affairs Branch (HFM-12), Center for Biologics Evaluation
and Research, Food and Drug Administration, 1401 Rockville Pike, suite
200 North, Rockville, MD 20852-1448, 301-594-1800. Send two self-
addressed adhesive labels to assist that office in processing your
requests. Persons with access to the INTERNET may request the guideline
be sent by return E-mail by sending a message to ``GDE--
[email protected]''. The guideline may also be obtained through
INTERNET via File Transfer Protocol (FTP). Requestors should connect to
the Center for Drug Evaluation and Research (CDER) FTP using the FTP.
The Center for Biologics Evaluation and Research (CBER) documents are
maintained in a subdirectory called CBER on the server,
``CDV2.CBER.FDA.GOV''. The ``READ.ME'' file in that subdirectory
describes the available documents, which may be available as an ASCII
text file (*.TXT), or a WordPerfect 5.1 document (*.w51), or both. A
sample dialogue for obtaining the READ.ME file with a test based FTP
program would be:
FTP CDV2.CBER.FDA.GOV
LOGIN ANONYMOUS
BINARY
CD CBER
GET READ.ME
EXIT
The guideline may also be obtained by calling the CBER FAX Information
System (FAX--ON--DEMAND) at 301-594-1939 from a FAX machine with a
touch tone phone attached or built-in. Submit written comments on this
guideline to the Dockets Management Branch (HFA-305), Food and Drug
Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857.
Requests and comments should be identified with the docket number found
in brackets in the heading of this document. Two copies of any comments
are to be submitted, except that individuals may submit one copy.
Requests and comments should be identified with the docket number found
in brackets in the heading of this document. The ``Guideline for
Quality Assurance in Blood Establishments'' and received comments are
available for public examination in the Dockets Management Branch
(address above) between 9 a.m. and 4 p.m., Monday through Friday.
FOR FURTHER INFORMATION CONTACT: Sharon A. Carayiannis, Center for
Biologics Evaluation and Research (HFM-635), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-594-3074.
SUPPLEMENTARY INFORMATION: On January 21 through 22, 1992, FDA
sponsored a public workshop on QA in the manufacture of blood and blood
products and provided a background information document on quality
assurance to all registrants. That workshop was announced in the
Federal Register on December 13, 1991 (56 FR 65094). FDA developed the
``Draft Guideline for Quality Assurance in Blood Establishments,''
dated June 17, 1993, following the meeting, after considering the
discussions at the workshop and comments received. FDA announced the
availability of the draft guideline in the Federal Register on July 2,
1993 (58 FR 35959), and solicited comments. FDA has revised the draft
guideline in response to public comment. The revisions are minor and
intended to clarify the document. This guideline, dated July 14, 1995,
provides general information on procedures and practices and may be
useful to blood establishments in developing and administering a QA
program.
To ensure the continued safety of the nation's blood supply, it is
essential that blood establishments implement effective control over
manufacturing processes and systems. FDA believes that this can be
accomplished by each blood establishment developing a well planned,
written, and managed QA program designed to recognize and prevent the
causes of recurrent deficiencies in blood establishment performance.
The emphasis of such a QA program is on preventing errors rather than
detecting them retrospectively. The potential public health
consequences require that all establishments, regardless of size,
invest in QA.
The guideline includes discussions of the following: (1) The
general concepts of a quality control/assurance program; (2) the
function and reporting responsibilities of the QA unit; (3) the
responsibilities of the QA unit in such areas as standard operating
procedures, training and education, competency evaluation, proficiency
testing, validation, equipment, error/accident reports, records
management, lot release procedures and QA audits; and (4) the
[[Page 36291]]
biological product and CGMP regulations for blood and blood components
in 21 CFR parts 600 through 680, and the CGMP regulations in 21 CFR
parts 210 through 211. In addition, the guideline contains a glossary,
a reference page, and an appendix that provides examples of the
regulations in 21 CFR parts 210, 211, and 21 CFR parts 600 through 680
supplementing each other.
This document is not being issued under the authority of 21 CFR
10.90(b) because FDA is in the process of revising this section. This
document, although called a guideline, does not bind the agency and
does not create or confer any rights, privileges, or benefits for or on
any person. Blood establishments may follow the guideline or may choose
to use alternative procedures not provided in the guideline. If a blood
establishment chooses to use alternative procedures, the establishment
may wish to discuss the matter further with the agency to prevent
expenditure of resources on activities that may be unacceptable to FDA.
Interested persons may, at any time, submit written comments to
the Dockets Management Branch (address above) regarding this guideline.
Two copies of any comments are to be submitted, except that individuals
may submit one copy. Comments are to be identified with the docket
number found in brackets in the heading of this document. Continued
comment by the blood industry is encouraged, and comments will be
continuously accepted by the Dockets Management Branch.
FDA periodically will review written comments on the guideline to
determine whether future revisions to the guideline are warranted.
Dated: July 11, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-17346 Filed 7-13-95; 8:45 am]
BILLING CODE 4160-01-F
