[Federal Register Volume 77, Number 149 (Thursday, August 2, 2012)]
[Pages 46096-46097]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-18854]



Food and Drug Administration

[Docket No.FDA-2012-N-0001]

Statistical Process Controls for Blood Establishments; Public 

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.


    The Food and Drug Administration (FDA) is announcing a public 
workshop entitled: ``Statistical Process Controls for Blood 
Establishments.'' The purpose of this public workshop is to discuss the 
implementation of statistical process controls to validate and monitor 
manufacturing processes in blood establishments. The public workshop 
has been planned in partnership with the AABB, America's Blood Centers, 
and the Department of Health and Human Services (HHS) Office of the 
Assistant Secretary for Health. The public workshop will include 
presentations and discussions led by experts from government and 
    Dates and Times: The public workshop will be held on October 19, 
2012, from 8:30 a.m. to 5 p.m.
    Location: The public workshop will be held at the FDA White Oak 
Campus, The Great Room, Bldg. 31, 10903 New Hampshire Ave. Silver 
Spring, MD, 20993. Please visit the following Web site for location, 
parking, security, and travel information: http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. The public workshop will also be available to be viewed 
online via webcast.
    Streaming Webcast of the Public Workshop: For those unable to 
attend in person, FDA will webcast the public workshop. To join the 
web-cast of the public workshop, please go to: https://collaboration.fda.gov/stat101912/.
    If you have never attended a Connect Pro meeting before: Test your 
connection: https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. Get a quick overview: http://www.adobe.com/go/connectpro_overview.
    Contact Person: Jennifer Scharpf, Center for Biologics Evaluation 
and Research (HFM-302), Food and Drug Administration, 1401 Rockville 
Pike, suite 200N, Rockville, MD 20852-1448, 301-827-6128, FAX: 301-827-
2843, email: [email protected].
    Registration: Mail, fax, or email your registration information 
(including name, title, firm name, address, telephone and fax numbers, 
and email address) to Jennifer Scharpf (see Contact Person) by 
September 27, 2012. Please indicate if you will attend the workshop in 
person or if you will participate in the webcast. There is no 
registration fee for the public workshop. Early registration is 
recommended because seating is limited. Those who wish to present at 
the workshop must attend in person. Registration on the day of the 
public workshop will be provided on a space-available basis beginning 
at 7:30 a.m.
    If you need special accommodations due to a disability, please 
contact Jennifer Scharpf (see Contact Person) at least 7 days in 
    Requests for Oral Presentations: Interested persons are invited to 
make presentations relevant to the public workshop topic. Attendees who 
wish to make presentations at the public workshop should notify the 
Contact Person and submit a brief statement of the general nature of 
the presentation before September 27, 2012. Presentations will be 
scheduled on the afternoon of October 19, 2012. Time allotted for each 
presentation may be limited depending on the number of individuals 
requesting to speak.

[[Page 46097]]

SUPPLEMENTARY INFORMATION: Statistical process control is the 
application of statistical methods to the monitoring, or quality 
control, of a manufacturing process. The implementation of acceptable 
statistical process controls ensures that a process performs 
predictably to manufacture a product that meets specific standards. FDA 
monitors manufacturing procedures, validation summaries, and quality 
control data prior to licensure and during periodic inspection of 
    Millions of units of Whole Blood and blood components, including 
those collected by apheresis, are manufactured in the United States 
annually. Blood establishments manufacture these products in accordance 
with specific standards established by FDA regulations and guidance, as 
well as in accordance with specifications established by device 
manufacturers and industry standards. To ensure that product standards 
are met, blood establishments validate manufacturing processes at 
implementation and then monitor these processes on a regular basis, 
using quality control methods.
    Manufacturing biologic products, including Whole Blood and blood 
components, comes with specific challenges due to biologic variability 
and the potential risk to recipients if products are not manufactured 
appropriately. Recognizing these issues, FDA has developed statistical 
plans that are capable of identifying when the manufacturing process 
varies or has a high frequency of nonconformance.
    The goal of the workshop is to educate participants on statistical 
process control theory and options for the implementation of 
scientifically sound sampling plans in blood establishments. The public 
workshop will include presentations and discussions on the following 
topics: (1) The evolution of statistical process control for Whole 
Blood and blood components; (2) statistical methods used for biologic 
product quality control; (3) FDA considerations for sampling plans for 
blood establishments; and (4) industry perspectives and case studies on 
implementing statistical process controls.
    Transcripts: Please be advised that a transcript of the public 
workshop will be posted as soon as possible on the Internet at: http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/TranscriptsMinutes/default.htm. 
Transcripts of the public workshop may also be requested in writing 
from the Division of Freedom of Information (ELEM-1029), Food and Drug 
Administration, 12420 Parklawn Dr., Rockville, MD 20857.

    Dated: July 27, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-18854 Filed 8-1-12; 8:45 am]