Guidelines

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Good Manufacturing Practices for Blood
Establishments (GMP for plasma donations)
Dr A Padilla Blood Products related
Biologicals Quality Assurance and Safety
Medicines World Health Organization
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OUTLINE
OUTLINE

• The GMP concept
• Good Manufacturing Practices for BE
• GMP compliance
• Impact of QA/GMP approach
• Website references

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GMP IN BLOOD ESTABLISHMENTS

• GMP addresses the manufacturing activities
  (collection, testing, process, storage,
  labelling, distribution) of the blood
  establishment
• Implementation of GMP requires to separate
  medical functions from manufacturing activities
  (e.g. plasma) in blood establishments

GMP applies to products and processes
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WHA63.12 "Blood Products" definition
"Any therapeutic substances derived from human
blood, including whole blood, labile blood
components and plasma-derived medicinal products"
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WHAT DO WE NEED TO ACHIEVE THROUGH GMP?

• CONTROL INHERENT BIOLOGICAL VARIABILITY
• CONSISTENCY OF PRODUCTION/PROCESSES
• TRACEABILITY DONOR RECIPIENT

each individual donation is unique
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HOW TO MANAGE THIS?

• To control the high variability, we need proof of
  a robust collection and production process
• To control the process, we need a systematic
  approach (the QA/GMP approach) to ensure
  compliance at all steps involved
• To apply the systematic production approach, each
  intermediate and final product must fulfil
  defined quality requirements pre-defined
  validated specifications

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GMP A TOOL TO CONTROL PROCESS VARIABILITY

• important to understand which characteristics are
  most relevant, and their impact, on products and
  processes
• measurable characteristics
• trend analysis to observe processes
• effective change control mechanisms

human plasma has intrinsic biological
variability
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TRACEABILITY FROM DONOR TO PATIENT
FRACTIONATION VIRAL INACTIVATION
DONOR INFORMATION
COMPONENTS SEPARATION
TREATMENT
Good Manufacturing Practices
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TRACEABILITY FROM DONOR TO PATIENT
Blood/Plasma donation
Blood Components
Patients
Plasma-Derived Medicinal Product
Plasma for Fractionation

• COMPONENTS PREPARATION, e.g.
• production process
• testing
• process control
• release
• storage transport

• DONOR/DONATION
• donor population
• donor registration
• donor selection
• donor protection
• collection process

• FRACTIONATION, e.g.
• fractionation process
• viral inactivation
• QC release
• distribution

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TRACEABILITY IS KEY

• unique donor/donation number
• clear identification of donor, donation, products
• post donation information
• effective information system between blood
  establishment, testing lab, hospital or plasma
  supplier and fractionation plant
• must work in both ways donor-patient-donor

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Plasma Contract Fractionation Programs- Need for
GMP implementation in BE -
GMP- common principles
GMP Licensing
Quality Assurance Program
GMP Licensing
Plasma Contract fractionation
across countries
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FROM DONOR TO PATIENT
FRACTIONATION VIRAL INACTIVATION
COMPONENTS PREPARATION
COLLECTION PROCESS
TREATMENT
TRACEABILITY LOOK BACK SYSTEM
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Good Manufacturing Practices (GMP) for Blood
establishments (BE) Definition
GMP is that part of QUALITY ASSURANCE that
ensures that products are consistently produced
to the quality standards appropriate to their
intended use, as required by predefined
specifications and, if applicable, by the
marketing authorisation. GMP is concerned with
both production and quality control. WHO
Guidelines for Blood Establishments (TRS 961,
Annex 4) http//www.who.int/entity/bloodproducts/
publications/GMP_Bloodestablishments.pdf
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GMP compliance issues specific to the production
of blood components, including plasma for
fractionation
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WHO GMP Guidelines contain...

• .. general GMP topics, e.g. quality management
• .. specific topics to manufacturing of blood
  components, from donor selection through
  distribution of final product
• .. newer GMP concepts, e.g. risk management,
  product quality reviews

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Structure of the Document

• Chapters 1