[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] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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 ANONYMOUSBINARY 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