FDA and American Red Cross
Blood Supply Safety &
Protection
Geoff Withnell, CQE, CQA, CQMgr
System Design Engineer
American Red Cross
Our Heritage
Henri Dunant
Founder of the
International Red Cross
and winner of the first
Nobel Prize.
Our Heritage
Clara Barton
Our founder
and First
President
Our Heritage
Dr. Charles Richard Drew
helped organize the first
Red Cross Blood Donor
Center
American Red Cross Biomedical Services
MISSION
The American Red Cross Biomedical
Services will fulfill the needs of the
American people, for the safest,
most reliable, most cost-effective
blood, plasma, and tissue services
through voluntary donations.
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Blood Is Manufactured Into:
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Red Blood Cells
Platelets
Plasma
Cryoprecipitate
More
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Food and Drug
Administration (FDA)
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Represents the American public.
Works to protect and promote the health
of the American people.
Enforces CGMP.
Shares goal with the Red Cross in seeking
to provide safe blood products.
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History of Laws &
Regulations for Blood
The Jungle
By Upton Sinclair
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History of Laws &
Regulations for Blood
The early years
Patient Medicine
The Jungle
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History Of Laws &
Regulations For Blood
Tainted
Diphtheria Antitoxin
Elixir
1902
Sulfanilamide
1938
Thalidomide
1962
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CGMP =
Current
Good
Manufacturing
Practice
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CGMP
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A standard for the whole industry
General requirements
Require interpretation
Contains words like
• Adequate
• Suitable
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The Code of Federal Regulations
(CFR) contains the CGMP
requirements.
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Drugs
(e.g., pain pills)
Parts 210 & 211
BLOOD
Biologics
(e.g., vaccines)
Parts 606 & 610
(for blood)
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FDA Regulations and
Guidance
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CFR
Guidelines, Guidance Documents,
Compliance Policy Guides, and
Standard Operating Procedures and
Policies (provide FDA’s current
thinking on the CGMP requirements)
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SQuIPP =
Safety
Quality
Identity
Potency
Purity
CGMP Focuses On:
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Processes
People
Materials and Supplies
Equipment
Work Environment/Facility.
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CGMP For Our Processes
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We must always follow our
SOPs. They have been validated
or proven to work in our process.
When followed exactly as
written they will produce
safe, quality products.
Always use the current
version of the SOP.
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CGMP for our People
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KEY CGMP BEHAVIOR: Take
your training seriously.
KEY CGMP BEHAVIOR: If you
do not feel competent to perform
a task/role, stop and speak up!
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CGMP for our Materials
and Supplies
KEY CGMP BEHAVIOR: Make
sure your supplies are
maintained properly prior to
use (e.g., sterile and not
expired).
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KEY CGMP BEHAVIOR: Use
your supplies correctly.
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CGMP For Our Equipment
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KEY CGMP BEHAVIOR: Follow
procedures and schedules for
calibrating, maintaining and cleaning
equipment.
KEY CGMP BEHAVIOR: Use
equipment the way it was intended.
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CGMP For Work Environment
And Facilities
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KEY CGMP BEHAVIOR: Keep your
work area clean and orderly, especially
to prevent contamination of our
products.
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How do we know we are
meeting the CGMP
requirements?
We have systems to monitor our
effectiveness:
 In Process Reviews & Checks
 Records Management System
 Problem Management System
 Quality Assurance Group
 Internal Audits/External Inspections.
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In Process Reviews & Checks
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During the process, we check
that we have followed the SOP.
We also do quality checks on
some of our products.
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Records are important
because they…
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Show what we did
Create a manufacturing
history of our products
Show whether or not we followed our
SOPs.
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Records…
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Must be
Clear, legible
 Permanent
 Concurrent
 Accurate
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Show who, what, when and with
which supplies and/or equipment.
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CGMP for Record Keeping
KEY CGMP BEHAVIOR:
Document accurately what you
do as soon as you do it.
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KEY CGMP BEHAVIOR: Sign
for your work and only your
work.
Mistakes happen…
The goal of the
Problem Management
System is to correct
problems now and
prevent their
recurrence in the
future.
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Problem Management System
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Track our mistakes.
Fix them.
Plan how not to make the mistake
again.
This is part of continuously
improving our processes.
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Problem Management
System
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KEY CGMP BEHAVIOR: Employees
must report problems.
KEY CGMP BEHAVIOR: Employees
must remain compliant despite
the pressures of their jobs.
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FDA Expects 5 Systems In Place
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Quality Assurance
Donor (Suitability) Eligibility System
Product Testing System
Quarantine/Inventory Management
System
Production and Processing System
Quality Assurance
The sum of activities planned and
performed to provide confidence that all
systems and their elements that influence
the quality of the product are functioning
as expected and relied upon.
(FDA’s Guideline for Quality Assurance in
Blood Establishments, July 11, 1995)
Donor (Suitability) Eligibility System
the system that protects donor
safety, determines a donor’s
suitability for blood collection
(including donor deferral from either
history screening and/or testing),
notifies donors of unsuitability for
donation and donor re-entry.
Product Testing System
the system(s) that tests for
communicable diseases, blood
grouping and typing, and
crossmatching blood for transfusion.
Quarantine/Inventory Management
System
the system(s) pertaining to product
storage, distribution and retrieval,
quarantine and distribution (release
for use or destruction).
Production and Processing System
process controls in the manufacture
of specific blood and blood
components, and equipment quality
control, calibration, and maintenance
Five Layers Of Safety
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Donor Screening
Donor Deferral
Product Testing
Quarantining
Monitoring and Investigating
Problems
Donor Screening
procedures to identify donors who
have defined risk factor(s) for
communicable disease(s) or who are
otherwise unsuitable to donate.
Donor Deferral
procedures to identify unsuitable
donors and prevent the distribution
of blood products collected from
these donors.
Product Testing
procedures to properly test blood for
required infectious diseases and
antigens and antibodies that may
cause a hemolytic transfusion
reaction.
Quarantining
procedures to assure that blood
products are quarantined until all
tests and control procedures are
acceptable and unsuitable products
are removed from inventory.
Monitoring and Investigating
Problems
procedures to identify system
problems, biologic product
deviations, and blood donor and
recipient adverse reactions and to
assure that adequate corrective
action is implemented.
Audits and Inspections
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Internal audit program
Inspections by
• FDA
• OSHA
• AABB
• State & Local Health Departments
These all tell us how we are doing in
complying with regulations.
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FDA Tools of Enforcement
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FDA 483’s
Warning letters
Injunction
Seizure of product
Criminal prosecution
Suspension/revocation of license
Closure
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Adulterated Product
FDA Meaning
A product may be deemed
“adulterated” if it isn’t made
according to CGMP
regulations, even if it isn’t
really contaminated.
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FDA Inspections
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Usually unannounced
Presents credentials (Badge), and a Form
FDA 482 or Amended Consent Decree
May observe procedures
May examine records
May interview staff
Any observations are presented at closing
meeting and in Form FDA 483.
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Inspection Outcomes and
FDA Actions
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483
Warning Letters
Consent Decree
Seizure of Products
Injunction/Suspension of Operations
Criminal Proceedings,
Suspension/revocation of license
Closure
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Personal Commitments
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Always place donor and patient
safety first.
Always understand and follow
SOPs, the CFR, and CGMP.
Always report any existing or
potential problems.
Take ownership of your job, make
it personal.
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