Click to edit Master title style Click to edit Master subtitle style February 2011 1 Regulatory framework for blood and blood components Transfusion Medicine

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1February 2011

Regulatory framework for blood and blood

components

Transfusion MedicineResidency Program

May 31, 2011



2February 2011

What is a Regulatory Framework?

Legislative Acts and Regulations

Non-legislative Policies Guidelines Directives Standards



3February 2011

Regulatory framework for blood and blood components

Legislative

Food and Drugs Act Definition of drugs includes blood and blood

components (Schedule D) Drugs not be to distributed unless safe Enforcement and powers of inspectors Regulation-making authority

Food and Drug Regulations, Part C (Drugs) Division 1 General requirements Division1a Establishment Licensing Division 2 Good Manufacturing Practices Division 4 Preparation from human

sources (pooled blood plasma, pooled blood serum) and plasmapheresis



4February 2011


Non-Legislative (1)

Policies (Interpretations of the purpose and intent of the Food and Drugs Act and Regulations)

The Distinction Between Advertising and Other Activities (2000)

Guidelines (To assist in the interpretation of the policies governing statutes and regulations)

GMP for Schedule D Drugs, Part 2 - Human Blood and Blood Components (1999)

Management of Blood Establishment Submissions (2006) Regulatory Requirements for Blood Establishment

Information Technology Submission (Draft 2008) Directives (Request for action)

Implementation of Prestorage Leukoreduction of Cellular Blood Components (1998)

Donor Exclusion to Address Theoretical Risk of Transmission of vCJD through the Blood Supply (1999, 2000, 2001, 2005)

Simian Foamy Virus (2006)



5February 2011


Non-Legislative (2) Consensus standards

Developed by Standards Development Organizations International Organization for Standardization (ISO) Canadian Standard Association (CSA) American National Standards Institute (ANSI)

Participation is opened to all affected interests (manufacturers, vendors, users, consumer groups, governments, professional and/or research organizations, etc.)

Balanced is maintained among competing interests Due process assures that all views will be considered and that

appeals are possible Are used within a regulatory framework e.g., CSA Standard - Blood and Blood Components (Z902)

Non-consensus standards Association/Industry Standards Representation and review is limited Are not used within a regulatory framework e.g., AABB’s Standards for Blood Banks and Transfusion

Services



6February 2011

Use of consensus standards in a regulatory framework

Reference consensus standard directly in Regulations The standard can not be in conflict with any statute,

regulations, or policies under which the regulator operates;

The standard is national or international in scope and approved by a Standards Development Organizations accredited by the Standards Council of Canada;

e.g., CAN/CSA-ISO 13485:2003 Reference specific clauses/sections of the standard in the

regulations e.g., Safety of Human Cells Tissues and Organs for

Transplantation Regulation and the CSA Standards (Z902)

Write the requirements directly in the Regulations Reference a Health Canada technical document in the

Regulations Recognize or translate, as applicable, the Standard in

Guidelines



7February 2011

Regulatory Oversight

Where does it start and end in relation to the management of the blood system?



8February 2011

Who Are The Regulators? The Big Picture

CBS

HPFBI(Health Canada)

CBER(FDA)

CNSCProvincial

MOH

MDB(Health Canada)

BGTD(Health

Canada)

Medical Laboratory FunctionsIrradiators

Procedures and Labels(Plasma for Fractionation)

InspectionsE/A&PDI ATE

SDE

ProceduralChange

Major/Serious other

TDG

Specimens forconfirmatory testing,

Waste units

Special Access



9February 2011

Scope of processes subject to licence amendments

Donation types

Regulated activities Support processes

Allogeneic Donor suitability assessment

Deviation Management*

Autologous

Collection Recalls*

Designated

Testing Adverse event reporting*

Directed Processing QC testing Walking

donor Transformation – pooling,

irradiation, washing, glyc/deglyc Storage * if criteria changes Transportation (shipping) Importation Collection of recovered

plasma for further manufacturing



10February 2011

Type of changes subject to licence notification

Addition of a new licensed test (Chagas)

Addition of QC testing (hemolysis)

Change in product expiry (5-day Plasma)

New transportation system for raw material

Change to Donor Selection Criteria (Age)



11February 2011

Impact of workload and BGTD’s review times (2009)

Category II Target Review Time - 20 Days

Total: 30

26 (87%) On Time4 (13%) Late

Category III Target Review Time - 45 Days

Total: 7

0 (0%) On Time7 (100%) Late

Category IV Target Review Time - 105 Days

Total: 9

6 (67%) On Time3 (33%) Late



12February 2011

Incident Reporting Requirements

Type of Occurrence Reporting Timeframe(from discovery by CBS)

Errors/Accidents 24 hours if Major/Serious/Critical/may impact safety of blood system

Semi-annually for all non-critical

Post-Donation Information Semi-annual Report

Adverse Transfusion Reaction 24 hours if life-threatening or fatal

15 days for others

Adverse Donor Event 24 hours if life-threatening or fatal

15 days if Donor hospitalized

Quarterly for others



13February 2011

Mandatory Reporting Voluntary Reporting Feedback Link BGTD Biologics & Genetic Therapies Directorate CBS Canadian Blood Services HPFBI Health Products & Foods Branch

Inspectorate MDB Medical Devices Bureau MHPD Marketed Health Products Directorate PHAC Public Health Agency of Canada PDI Post-Donation Information SDE Serious Donor Event TTISS Transfusion Transmitted Injuries

Surveillance System

Reporting of Adverse EventsLegend



14February 2011



15February 2011

Errors, Accidents, Post-Donation Information & Serious

Donor Events

CBS

Centre

Donor

CBS

Head Office

BGTD

PDI or SDE

Hospital CBS Staff

Product Problem

ErrorOr

Accident

HPFBI

E/AReportable

in 24 hr or less



16February 2011

Product Problems

Hospital

CBS

BGTD

Fractionator

Plasma Protein Products Blood & Blood Components

If Problem results from Error or Accident

If Problem results from Error or Accident



17February 2011

Supplier Notifications

Hospital

CBS

Head Office

BGTD

Supplier

MDB

CBS

Centres

If CBS products affected

If CBS products affected

HPFBI



18February 2011

Adverse Reactions to Transfusion

Blood & Blood Components

Hospital

Provincial

Blood Office

TTISS

CBS

BGTD

Fractionator

MHPD

Plasma Protein Products

PHAC



19February 2011

Adverse Events reported to CBS

Between 1 April 2009 and 31 March 2010, 113 adverse events were reported to Canadian Blood Services.

TRALI or suspected TRALI 33Febrile reaction 24TACO 16Anaphylactic 6Suspected bacterial 4Delayed hemolytic 6Allergic 3PTP 1Miscellaneous 20



20February 2011

Regulatory Compliance

Monitor release of new / revised Regulations & Standards

Change Control Process

Work Instructions for staff



21February 2011

Regulatory Compliance

Corporate Audits

Supplier Audits

Inspection by Regulator



22February 2011

In summary

Scope of processes subject to licence notification:

For product related processes, regulatory oversight exercised through the licence notification process

For most of the support processes, regulatory oversight exercised through the audit/inspection process

Type of changes subject to licence notification: Risk based

Reporting requirements: Major, serious or critical



23February 2011



24February 2011

Documents

Click to edit Master title style Click to edit Master subtitle style February 2011 1 Regulatory framework for blood and blood components Transfusion Medicine