plasma quality

GMP IN
BLOOD ESTABLISHMENTS:
A BASIC ELEMENT FOR
PLASMA QUALITY
Dr. Christian Schärer
Swissmedic, Swiss Agency for Therapeutic Products
Inspectorates, Hallerstrasse 7
CH-3000 Bern 9
[email protected]
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PLASMA QUALITY:
WHAT IS THE AIM (I)?
9 Improving the quality and safety of
9plasma for fractionation as starting material
9blood components for transfusion
9 Optimising the use of a blood donation
9Less discarded units
9Increase availability of plasma
9Contract fractionation programs
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PLASMA QUALITY:
WHAT IS THE AIM (II)?
9 Strengthen the NRA’s technical expertise in regulating
blood products
9 Establishment of regional network between
professionals (blood establishments, fractionator)
9 Harmonisation in the regulation of blood and blood
products
9 Facilitate international cooperation between NRA’s
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NEEDS
Î Agreed quality and safety requirements, specifications
and standards for blood/plasma collection, preparation,
testing and distribution activities
Î A harmonised and systematic approach to ensure
compliance at all steps involved
Î Implementation of standards in the blood
establishments
Î Enforcement by competent regulatory authority
Î Building up the necessary technical expertise in NRA
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EXPERIENCE FROM PREVIOUS ACTIVITIES
WHO Workshops on GMP for Blood Establishments
(e.g. WHO/AMRO PAHO, Buenos Aires (ARG) in 2004)
Î Existing GMP standards used as working
documents for training
Î GMP as a common language between blood
establishments and fractionator
Î In blood establishments, the understanding for
need of implementing quality assurance exists
Î Development of GMP standards for blood
establishments needed
Î Harmonisation and collaboration on a regional
level (at least) is important
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IMPLEMENTATION OF GMP IN BLOOD
ESTABLISHMENTS IS IMPORTANT
FOR PLASMA QUALITY
Safety
Quality
Availability
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IMPACT OF GMP IN BLOOD
ESTABLISHMENTS (I)
9 In blood establishments, GMP introduces the
application of quality assurance principles in all steps
involved in the collection, preparation, testing and
distribution activities
9 Benefits for quality and safety of blood components
for transfusion and of plasma for fractionation
Good Manufacturing Practice (GMP):
GMP is that part of Quality Assurance which ensures that products are
consistently produced and controlled to the quality standards appropriate to their
intended use and as required by the marketing authorization or product
specification. GMP is concerned with both production and quality control.
(PIC/S GMP Guide PE 009-7, Ch. 1.3)
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IMPACT OF GMP IN BLOOD
ESTABLISHMENTS (II)
9 GMP supports systematic application of donor
selection criteria for each donation
9 GMP ensures appropriate testing methods and testing
kits, and use of suitable reagents
9 GMP requires the use of suitable facilities, equipment
and materials
9 GMP reduces errors and technical problems in
collection, preparation, testing, and distribution
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IMPACT OF GMP IN BLOOD
ESTABLISHMENTS (III)
9 GMP ensures the existence of validated and robust
processes, e.g.
ƒ Disinfection of puncture site before collection
ƒ Separation process
ƒ Testing methods
ƒ Freezing of plasma
ƒ Transport (-> cold chain)
9 GMP guarantees the release of products which comply
with the safety and quality requirements
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IMPACT OF GMP IN BLOOD
ESTABLISHMENTS (IV)
9 GMP ensures adequate documentation and full
traceability for each collection and product, from
donor to recipient
9 GMP strengthens the competence of the personnel
9 GMP enables continuous improvement in collection,
preparation and testing of starting material
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GMP IN BLOOD ESTABLISHMENTS:
IMPACT ON AVAILABILITY
9 Improvement of quality of plasma
9 Plasma is a precious starting material and could be
used for fractionation if quality is assured.
9 More plasma would be available and less plasma
would be discarded, finally resulting also in an
increase of the availability of blood products.
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SOME ECONOMIC ASPECTS
9 Achieving plasma of high quality and safety is very
demanding
9commitment of all involved parties
9human resources
9financial expenditure
-> approach with maximal benefit
9 Less errors and technical problems, better quality
of plasma
-> less waste of products
-> better use of precious donation
9 Facilitation of Plasma Contract Fractionation
Programs -> availability of blood products
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GMP IN BLOOD ESTABLISHMENTS:
IMPACT ON COOPERATION
9 Building up a common language and confidence for
regional or international cooperation between NRA
in the regulation of blood and blood products
9 Building up a common understanding between
NRA, blood establishments and fractionation
¾Establishment of regional professional network
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What GMP standards?
Existing specific GMP
Guide for Blood
Establishments,
e.g. PIC/S
WHO Recommendations for the
production, control and
regulation of plasma for
fractionation
WHO Technical Report Series 941,
Annex 4. Adopted by the 56th meeting
of the WHO Expert Committee on
Biological Standardization, 24-28
October 2005.
Draft WHO Guideline for GMP
in Blood Establishment
(scheduled for consultation in 2009)
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PROJECT FOR A WHO GMP GUIDELINE
FOR BLOOD ESTABLISHMENTS
Î Responding to an ICDRA recommendation:
-> development of a WHO GMP Guideline for Blood
Establishments
Î Jan-April 08: Draft document prepared by drafting group
(C. Schärer [Switzerland], L. van Loosbroek [The Netherlands],
W. Atkins [US])
Î Revision and finalisation of draft
- after discussions with some experts
- use as working document in training workshop Nov 08
Î Open consultation of document in 2009
Î Presentation for adoption at the ECBS in October 2009
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CONCLUSIONS
9 GMP in blood establishments will be a beneficial
tool to help countries in improving plasma quality.
9 The use of harmonised GMP standards will facilitate
regional collaboration between NRA‘s, and will
serve as a common language between the plasma
supplier and the fractionator.
9The WHO Guideline will help countries in the
implementation of GMP in blood establishments.
9GMP in blood establishments will increase
availability of plasma and is one of the key issues
for a successful plasma contract fractionation
program.
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