FDA and American Red Cross FDA and American Red Cross

Blood Supply Safety &Blood Supply Safety &

ProtectionProtection

Geoff Withnell, CQE, CQA, CQMgrGeoff Withnell, CQE, CQA, CQMgr

System Design Engineer System Design Engineer

American Red CrossAmerican Red Cross

Our HeritageOur Heritage

Henri Dunant

Founder of the International Red Cross and winner of the first

Nobel Prize.

Our HeritageOur Heritage

Clara Barton

Our founder and First President

Our HeritageOur Heritage

Dr. Charles Richard Drew helped organize the first Red Cross Blood Donor

Center

American Red Cross Biomedical ServicesAmerican Red Cross Biomedical ServicesMISSIONMISSION

The American Red Cross Biomedical The American Red Cross Biomedical Services will fulfill the needs of the Services will fulfill the needs of the American people, for the safest, most American people, for the safest, most reliable, most cost-effective blood, reliable, most cost-effective blood, plasma, and tissue services through plasma, and tissue services through voluntary donations.voluntary donations.

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Blood Is Manufactured Into:Blood Is Manufactured Into:

Red Blood CellsRed Blood Cells PlateletsPlatelets PlasmaPlasma CryoprecipitateCryoprecipitate MoreMore

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Food and Drug Food and Drug Administration (FDA)Administration (FDA)

Represents the American public.Represents the American public.

Works to protect and promote the health Works to protect and promote the health of the American people.of the American people.

Enforces CGMP.Enforces CGMP.

Shares goal with the Red Cross in seeking Shares goal with the Red Cross in seeking to provide safe blood products.to provide safe blood products.

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The Jungle

By Upton Sinclair

History of Laws & History of Laws & Regulations for BloodRegulations for Blood

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History of Laws & History of Laws & Regulations for BloodRegulations for Blood

The early years

Patient Medicine

The Jungle

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History Of Laws & History Of Laws & Regulations For BloodRegulations For Blood

Tainted

Diphtheria Antitoxin

1902 Elixir

Sulfanilamide

1938Thalidomide

1962

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CGMP =

Current

Good

Manufacturing

Practice1

CGMPCGMP

A standard for the whole industryA standard for the whole industry General requirementsGeneral requirements Require interpretationRequire interpretation Contains words likeContains words like

• AdequateAdequate• SuitableSuitable

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The Code of Federal Regulations The Code of Federal Regulations (CFR) contains the CGMP (CFR) contains the CGMP

requirements.requirements.

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DrugsDrugs (e.g., pain pills)(e.g., pain pills)

Parts 210 & 211Parts 210 & 211

BiologicsBiologics(e.g., vaccines)(e.g., vaccines)

Parts 606 & 610 Parts 606 & 610

(for blood)(for blood)

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BLOOD

FDA Regulations and FDA Regulations and GuidanceGuidance

CFRCFR

Guidelines, Guidance Documents, Guidelines, Guidance Documents, Compliance Policy Guides, and Compliance Policy Guides, and Standard Operating Procedures and Standard Operating Procedures and Policies (provide FDA’s current Policies (provide FDA’s current thinking on the CGMP requirements)thinking on the CGMP requirements)

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SQuIPP =

SSafetyafety

QuQualityality

IIdentitydentity

PPotencyotency

PPurityurity

CGMP Focuses On:CGMP Focuses On:

ProcessesProcesses PeoplePeople Materials and SuppliesMaterials and Supplies EquipmentEquipment Work Environment/Facility.Work Environment/Facility.

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CGMP For Our ProcessesCGMP For Our Processes

We must We must always followalways follow our our SOPs. SOPs. They have been validated They have been validated

or proven to work in our processor proven to work in our process.. When followed When followed exactly as exactly as

writtenwritten they will produce they will produce safe, quality products.safe, quality products.

Always use the Always use the current current versionversion of the SOP. of the SOP.

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CGMP for our PeopleCGMP for our People

KEY CGMP BEHAVIOR:KEY CGMP BEHAVIOR: Take Take your training seriously. your training seriously.

KEY CGMP BEHAVIOR:KEY CGMP BEHAVIOR: If you If you do not feel competent to perform do not feel competent to perform a task/role, stop and speak up!a task/role, stop and speak up!

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CGMP for our Materials CGMP for our Materials and Suppliesand Supplies

KEY CGMP BEHAVIOR:KEY CGMP BEHAVIOR: Make Make sure your supplies are sure your supplies are maintained properly prior to use maintained properly prior to use (e.g., sterile and not expired).(e.g., sterile and not expired).

KEY CGMP BEHAVIOR:KEY CGMP BEHAVIOR: Use Use your supplies correctly.your supplies correctly.

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CGMP For Our EquipmentCGMP For Our Equipment

KEY CGMP BEHAVIOR:KEY CGMP BEHAVIOR: Follow Follow procedures and schedules for procedures and schedules for calibrating, maintaining and cleaning calibrating, maintaining and cleaning equipment.equipment.

KEY CGMP BEHAVIOR:KEY CGMP BEHAVIOR: Use Use equipment the way it was intended.equipment the way it was intended.

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CGMP For Work Environment CGMP For Work Environment And FacilitiesAnd Facilities

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

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How do we know we are How do we know we are meeting the CGMP meeting the CGMP

requirements?requirements?We have We have systemssystems to monitor our to monitor our

effectiveness:effectiveness: In Process Reviews & ChecksIn Process Reviews & Checks Records Management SystemRecords Management System Problem Management System Problem Management System Quality Assurance GroupQuality Assurance Group Internal Audits/External Inspections.Internal Audits/External Inspections.

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In Process Reviews & ChecksIn Process Reviews & Checks

During the process, we check During the process, we check that we have followed the SOP.that we have followed the SOP.

We also do quality checks on We also do quality checks on some of our products.some of our products.

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Records are important Records are important because they…because they…

Show what we did Show what we did

Create a manufacturing Create a manufacturing

history of our productshistory of our products

Show whether or not we followed our Show whether or not we followed our SOPs.SOPs.

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Records…Records…

Must be Must be Clear, legibleClear, legible PermanentPermanent ConcurrentConcurrent AccurateAccurate

Show who, what, when and with Show who, what, when and with which supplies and/or equipment.which supplies and/or equipment.

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CGMP for Record KeepingCGMP for Record Keeping

KEY CGMP BEHAVIOR:KEY CGMP BEHAVIOR: Document accurately what you Document accurately what you do as soon as you do it.do as soon as you do it.

KEY CGMP BEHAVIOR:KEY CGMP BEHAVIOR: Sign for Sign for your work and only your work.your work and only your work.

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Mistakes happen…Mistakes happen…

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

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Problem Management SystemProblem Management System

Track our mistakes.Track our mistakes. Fix them.Fix them. Plan how not to make the mistake Plan how not to make the mistake

again.again.

This is part of This is part of continuouslycontinuously improvingimproving our processes. our processes.

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Problem ManagementProblem ManagementSystemSystem

KEY CGMP BEHAVIOR:KEY CGMP BEHAVIOR: Employees Employees must reportmust report problems problems..

KEY CGMP BEHAVIOR:KEY CGMP BEHAVIOR: Employees Employees must remain compliant must remain compliant despite despite the pressures of their jobs.the pressures of their jobs.

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FDA Expects 5 Systems In PlaceFDA Expects 5 Systems In Place

Quality AssuranceQuality Assurance Donor (Suitability) Eligibility System Donor (Suitability) Eligibility System Product Testing System Product Testing System Quarantine/Inventory Management Quarantine/Inventory Management

System System Production and Processing System Production and Processing System

Quality AssuranceQuality Assurance

The sum of activities planned and The sum of activities planned and performed to provide confidence that all performed to provide confidence that all systems and their elements that influence systems and their elements that influence the quality of the product are functioning the quality of the product are functioning as expected and relied upon. as expected and relied upon.

(FDA’s Guideline for Quality Assurance in (FDA’s Guideline for Quality Assurance in

Blood Establishments, July 11, 1995)Blood Establishments, July 11, 1995)

Donor (Suitability) Eligibility System Donor (Suitability) Eligibility System

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

Product Testing System Product Testing System

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

Quarantine/Inventory Management Quarantine/Inventory Management System System

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

Production and Processing System Production and Processing System

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

Five Layers Of Safety Five Layers Of Safety

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

Problems Problems

Donor Screening Donor Screening

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

Donor Deferral Donor Deferral

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

Product Testing Product Testing

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

Quarantining Quarantining

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

Monitoring and Investigating Monitoring and Investigating Problems Problems

procedures to identify system procedures to identify system problems, biologic product problems, biologic product deviations, and blood donor and deviations, and blood donor and recipient adverse reactions and to recipient adverse reactions and to assure that adequate corrective assure that adequate corrective action is implemented. action is implemented.

Audits and InspectionsAudits and Inspections

Internal audit programInternal audit program Inspections byInspections by

• FDAFDA• OSHAOSHA• AABBAABB• State & Local Health DepartmentsState & Local Health Departments

These all tell us how we are doing in These all tell us how we are doing in complying with regulations.complying with regulations.

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FDA Tools of EnforcementFDA Tools of Enforcement

FDA 483’sFDA 483’s Warning lettersWarning letters InjunctionInjunction Seizure of productSeizure of product Criminal prosecutionCriminal prosecution Suspension/revocation of licenseSuspension/revocation of license ClosureClosure

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Adulterated ProductAdulterated ProductFDA MeaningFDA Meaning

A product may be deemed A product may be deemed “adulterated” if it “adulterated” if it isn’t made isn’t made according to CGMP according to CGMP regulationsregulations, , even if it isn’t even if it isn’t really contaminatedreally contaminated..

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FDA InspectionsFDA Inspections

Usually unannouncedUsually unannounced Presents credentials (Badge), and a Form Presents credentials (Badge), and a Form

FDA 482 or Amended Consent DecreeFDA 482 or Amended Consent Decree May observe proceduresMay observe procedures May examine recordsMay examine records May interview staffMay interview staff Any observations are presented at closing Any observations are presented at closing

meeting and in Form FDA 483.meeting and in Form FDA 483.

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Inspection Outcomes andInspection Outcomes andFDA ActionsFDA Actions

483483 Warning LettersWarning Letters Consent DecreeConsent Decree Seizure of ProductsSeizure of Products Injunction/SuspensionInjunction/Suspension of Operationsof Operations Criminal ProceedingsCriminal Proceedings, , Suspension/revocation of license Suspension/revocation of license ClosureClosure

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Personal CommitmentsPersonal Commitments

Always place donor and patient Always place donor and patient safety first.safety first.

Always understand and follow Always understand and follow SOPs, the CFR, and CGMP.SOPs, the CFR, and CGMP.

Always report any existing or Always report any existing or potential problems.potential problems.

Take ownership of your job, make Take ownership of your job, make it personal.it personal.

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