FDA and American Red Cross Blood Supply Safety & Protectio

1

• FDA and American Red Cross
• Blood Supply Safety
• Protection
• Geoff Withnell, CQE, CQA, CQMgr
• System Design Engineer
• American Red Cross

2
Our Heritage
Henri Dunant Founder of the International Red
Cross and winner of the first Nobel Prize.
3
Our Heritage
Clara Barton Our founder and First President
4
Our Heritage
Dr. Charles Richard Drew helped organize the
first Red Cross Blood Donor Center
5
American Red Cross Biomedical ServicesMISSION

• 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.

1
6
Blood Is Manufactured Into

• Red Blood Cells
• Platelets
• Plasma
• Cryoprecipitate
• More

1
7
Food and Drug Administration (FDA)

• 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.

1
8
History of Laws Regulations for Blood
The Jungle By Upton Sinclair
2
9
History of Laws Regulations for Blood
The early years
Patient Medicine
The Jungle
2
10
History Of Laws Regulations For Blood
Tainted Diphtheria Antitoxin 1902
Elixir Sulfanilamide 1938
Thalidomide 1962
2
11
CGMP Current Good Manufacturing Practice
1
12
CGMP

• A standard for the whole industry
• General requirements
• Require interpretation
• Contains words like
• Adequate
• Suitable

1
13
The Code of Federal Regulations (CFR) contains
the CGMP requirements.
1
14
Drugs (e.g., pain
pills) Parts 210 211 Biologics
(e.g., vaccines)
Parts 606 610 (for blood)
BLOOD
2
15
FDA Regulations and Guidance

• CFR
• Guidelines, Guidance Documents, Compliance Policy
  Guides, and Standard Operating Procedures and
  Policies (provide FDAs current thinking on the
  CGMP requirements)

2
16
SQuIPP

• Safety
• Quality
• Identity
• Potency
• Purity

17
CGMP Focuses On

• Processes
• People
• Materials and Supplies
• Equipment
• Work Environment/Facility.

2
18
CGMP For Our Processes

• 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.

2
19
CGMP for our People

• 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!

2
20
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).
• KEY CGMP BEHAVIOR Use your supplies correctly.

2
21
CGMP For Our Equipment

• KEY CGMP BEHAVIOR Follow procedures and
  schedules for calibrating, maintaining and
  cleaning equipment.
• KEY CGMP BEHAVIOR Use equipment the way it was
  intended.

2
22
CGMP For Work Environment And Facilities

• KEY CGMP BEHAVIOR Keep your work area clean and
  orderly, especially to prevent contamination of
  our products.

2
23
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.

3
24
In Process Reviews Checks

• During the process, we check that we
  have followed the SOP.
• We also do quality checks on some of our
  products.

3
25
Records are important because they

• Show what we did
• Create a manufacturing
• history of our products
• Show whether or not we followed our SOPs.

3
26
Records

• Must be
• Clear, legible
• Permanent
• Concurrent
• Accurate
• Show who, what, when and with which supplies
  and/or equipment.

3
27
CGMP for Record Keeping

• KEY CGMP BEHAVIOR Document accurately what you
  do as soon as you do it.
• KEY CGMP BEHAVIOR Sign for your work and only
  your work.

3
28
Mistakes happen

• The goal of the Problem Management System is to
  correct problems now and prevent their recurrence
  in the future.

3
29
Problem Management System

• Track our mistakes.
• Fix them.
• Plan how not to make the mistake again.
• This is part of continuously improving our
  processes.

3
30
Problem ManagementSystem

• KEY CGMP BEHAVIOR Employees must report
  problems.
• KEY CGMP BEHAVIOR Employees must remain
  compliant despite the pressures of their jobs.

3
31
FDA Expects 5 Systems In Place

• Quality Assurance
• Donor (Suitability) Eligibility System
• Product Testing System
• Quarantine/Inventory Management System
• Production and Processing System

32
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.
• (FDAs Guideline for Quality Assurance in
• Blood Establishments, July 11, 1995)

33
Donor (Suitability) Eligibility System

• the system that protects donor safety,
  determines a donors suitability for blood
  collection (including donor deferral from either
  history screening and/or testing), notifies
  donors of unsuitability for donation and donor
  re-entry.

34
Product Testing System

• the system(s) that tests for communicable
  diseases, blood grouping and typing, and
  crossmatching blood for transfusion.

35
Quarantine/Inventory Management System

• the system(s) pertaining to product storage,
  distribution and retrieval, quarantine and
  distribution (release for use or destruction).

36
Production and Processing System

• process controls in the manufacture of specific
  blood and blood components, and equipment quality
  control, calibration, and maintenance

37
Five Layers Of Safety

• Donor Screening
• Donor Deferral
• Product Testing
• Quarantining
• Monitoring and Investigating Problems

38
Donor Screening

• procedures to identify donors who have defined
  risk factor(s) for communicable disease(s) or who
  are otherwise unsuitable to donate.

39
Donor Deferral

• procedures to identify unsuitable donors and
  prevent the distribution of blood products
  collected from these donors.

40
Product Testing

• procedures to properly test blood for required
  infectious diseases and antigens and antibodies
  that may cause a hemolytic transfusion reaction.

41
Quarantining

• procedures to assure that blood products are
  quarantined until all tests and control
  procedures are acceptable and unsuitable products
  are removed from inventory.

42
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.

43
Audits and Inspections

• Internal audit program
• Inspections by
• FDA
• OSHA
• AABB
• State Local Health Departments
• These all tell us how we are doing in complying
  with regulations.

3
44
FDA Tools of Enforcement

• FDA 483s
• Warning letters
• Injunction
• Seizure of product
• Criminal prosecution
• Suspension/revocation of license
• Closure

4
45
Adulterated ProductFDA Meaning

• A product may be deemed adulterated if it
  isnt made according to CGMP regulations, even if
  it isnt really contaminated.

4
46
FDA Inspections

• 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.

4
47
Inspection Outcomes andFDA Actions

• 483
• Warning Letters
• Consent Decree
• Seizure of Products
• Injunction/Suspension of Operations
• Criminal Proceedings,
• Suspension/revocation of license
• Closure

4
48
Personal Commitments

• 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.

4
49
4