WHO Regional Workshop on Good Manufacturing Practices for Blood Establishments Dr Ana Padilla, Blood Products & related Biologicals Essential Medicines.

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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

HSS/EMP/BPB: Teheran, Oct 08 2 |2 | 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 Good Manufacturing Practices (GMP): an essential tool for improvement of safety

HSS/EMP/BPB: Teheran, Oct 08 3 |3 | 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 Assuring Blood/Plasma Safety : “Layers of Safety”

HSS/EMP/BPB: Teheran, Oct 08 4 |4 | 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 WORKSHOP OBJECTIVES

HSS/EMP/BPB: Teheran, Oct 08 5 |5 | International Conference of Drug Regulatory Authorities 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

HSS/EMP/BPB: Teheran, Oct 08 6 |6 | International Conference of Drug Regulatory Authorities International Conference of Drug Regulatory Authorities (ICDRA): Recommendations, Bern 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 Emerging Diseases: regulating blood products (ICDRA: Recommendations, Bern 08) Scope: Blood Establishments and National Regulatory Authorities

HSS/EMP/BPB: Teheran, Oct 08 7 |7 | OUTLINE  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 Overall Objectives

HSS/EMP/BPB: Teheran, Oct 08 8 |8 | WHO Regional Workshop on Good Manufacturing Practices for Blood Establishments WHO Regional Workshop on Good Manufacturing Practices for Blood Establishments Teheran 1 – Teheran 1 – Recommendation Recommendation

HSS/EMP/BPB: Teheran, Oct 08 9 |9 | Recommendation to WHO Representative from Member states request WHO to develop and adopt WHO GMP guidelines for blood establishments by end ‏ 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.

HSS/EMP/BPB: Teheran, Oct | International Conference of Drug Regulatory Authorities International Conference of Drug Regulatory 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 Recommendation to MOH

HSS/EMP/BPB: Teheran, Oct | Recommendation to Blood establishments Assure implementation of GMP including appropriate training of staff and internal auditors in blood establishments.