fda and american red cross blood supply safety & protection geoff withnell, cqe, cqa, cqmgr...
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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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