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WHO Regional Workshop on
Good Manufacturing Practices
for Blood Establishments
Dr Ana Padilla,
Blood Products & related Biologicals
Essential Medicines and Pharmaceutical Policies Department
Health Services and Systems Cluster
World Health Organization
Teheran, 1-4 Nov. 08
Good Manufacturing Practices (GMP):
an essential tool for improvement of safety
GMP implementation in Blood/Plasma
Establishments: a key element to
Quality and safety of blood components
Plasma contract fractionation programs
Supporting access to blood plasma products
2 | HSS/EMP/BPB: Teheran, Oct 08
Assuring Blood/Plasma Safety:
“Layers of Safety”
1. Donor selection criteria (epidemiological data)
2. Deferral procedures: national registries to avoid use of
collections from previously unsuitable donors
3. Laboratory testing for infectious disease markers:
selection of kits and validation
4. Implementation of GMPs in blood establishments
3 | HSS/EMP/BPB: Teheran, Oct 08
WORKSHOP OBJECTIVES
1. Facilitate understanding and added value of implementation of
GMP concept in the context of blood establishments
2. Facilitate appropriate communication of blood establishments
and regulatory authorities in the context of GMP
3. Identify countries needs to support GMP implementation
4. Assure input to the proposed WHO Guidelines for GMP in
blood establishments
4 | HSS/EMP/BPB: Teheran, Oct 08
International Conference of Drug Regulatory
Authorities (ICDRA): Recommendations
 Regulation of Blood and Blood-Derived Products: Global Challenges
» Update legal provisions to strengthen blood products regulation
» Facilitate GMP enforcement in blood and plasma establishments
» Promote creation of regional networks of national authorities
involved in the regulation of blood and blood products
» Encourage development of risk-based regulatory strategies
Scope:
Blood Establishments and National Regulatory Authorities
5 | HSS/EMP/BPB: Teheran, Oct 08
International
Conference
of Drugblood
Regulatory
Emerging
Diseases:
regulating
products
Authorities
(ICDRA):
Recommendations,
(ICDRA:
Recommendations,
BernBern
08) 2008
 Recognizing the need worldwide for blood products regulation to
ensure availability of safe blood and blood products in the face of
known and emerging threats, including emerging infectious diseases,
WHO should:
» Prioritize development of Guidelines on GMP for Blood Establishments
» Promote introduction of WHO recommended plasma standards by NRAs
» Take steps to further develop and strengthen national/regional blood regulatory
authorities and to promote cooperation
Scope:
Blood Establishments and National Regulatory Authorities
6 | HSS/EMP/BPB: Teheran, Oct 08
OUTLINE
Overall
Objectives

To promote implementation of GMP by blood
establishments

Facilitate GMP enforcement in blood and plasma
establishments

Common GMP standard: a basis for mutual recognition of
quality standards and inspections results between NRA's

Promote introduction of blood products regulations
7 | HSS/EMP/BPB: Teheran, Oct 08

WHO Regional Workshop on
Good Manufacturing Practices
for Blood Establishments

Teheran 1 – 4 2008

Recommendation

8 | HSS/EMP/BPB: Teheran, Oct 08
Recommendation to WHO
 Representative from Member states request WHO to develop and
adopt WHO GMP guidelines for blood establishments by end 2009.
 Further to the establishment of WHO guide lines, to develop and
implement training courses for inspectors on GMP in blood
establishment at Regional level as required .
 To support cooperation between countries and to foster regional
networks to develop appropriate GMP regulations in blood
establishments.
 To Communicate the outcome of this meeting to MOH and WR
asking for organizing national meeting of blood establishments and
regulatory authorities to develop national situation report regarding
regulation of blood and blood products by medicines regulatory
authority in member states.
9 | HSS/EMP/BPB: Teheran, Oct 08
International Conference of Drug Regulatory
Recommendation
to
MOH
Authorities (ICDRA): Recommendations, Bern 2008
 Recognizing the need worldwide for blood products regulation to ensure availability
and affordability of safe blood and blood products,
 Member States should:
» Update legal provisions to strengthen blood and blood products regulations
including the enforcement of GMP in blood establishments under the umbrella
of the Medicines Regulatory Authorities
» To support implementation of GMP in blood establishments
 Establishment and strengthen of coordinated national blood transfusion services
 Train inspectors within the regulatory frame work independent of blood
establishments
10 | HSS/EMP/BPB: Teheran, Oct 08
Recommendation to Blood establishments
 Assure implementation of GMP including appropriate
training of staff and internal auditors in blood
establishments.
11 | HSS/EMP/BPB: Teheran, Oct 08