[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]
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