Impact of WHO Guidelines on GMP for Blood Establishments

Transcription

1 Impact of WHO Guidelines on GMP for Blood Establishments Christian Schärer, Ph.D. Swissmedic, Swiss Agency for Therapeutic Products, Head Inspectorate International Conference of Drug Regulatory Authorities (ICDRA), Singapore, 30 November 3 December 2010 Swissmedic Swiss Agency for Therapeutic Products Hallerstrasse 7 CH-3000 Bern

2 International Conference of Drug Regulatory Authorities (ICDRA): Recommendations, Bern 2008 Recognizing the worldwide need 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: Take steps to further develop and strengthen national / regional blood regulatory authorities and to promote cooperation Provide harmonized "assessment criteria for blood regulatory systems" (BRN): convene a consultation of NRAs to review draft assessment tools Prioritize development of WHO Guidelines on GMP for Blood Establishments Promote introduction of WHO recommended plasma standards by NRAs 2 2

3 Resolution WHA Availability, safety and quality of blood products (63th World Health Assembly, Geneva, WHO, 2010) Underlines the importance of establishing reliable quality assurance systems covering the whole chain from blood collection, processing and distribution of blood components in blood establishments 3 3

4 New WHO guidelines 4 4

5 Objectives of WHO Guidelines on GMP for blood establishments To provide a guidance document for blood establishments and for NRAs to refer, implement and enforce GMP in blood establishments Complementary to existing WHO GMP standards, taking into account the specifics of blood products and blood establishments To establish a WHO Guideline to support quality assurance activities in blood establishments for the production of blood components at global level 5 5

6 Drafting process Drafting group: J. W. Atkins, NIH Transfusion Medicine Department, USA Dr. C. Schärer, Swissmedic, Switzerland D. Schmidkunz-Eggler, Swissmedic, Switzerland Priv. Doz. Dr. G. Werner, Paul-Ehrlich-Institut, Germany Dr. A. Padilla, Blood Products and related Biologicals, WHO Jan-April 08 Nov 08 July-Sept 09 Oct 09 Draft document WHO Regional Workshop (Teheran) Consultation WHO Blood Regulators Network (BRN) Project presentation to ECBS and ECSPP, release for open consultation 6 6

7 Drafting process (cont.) Jan-April 2010 Open global consultation Blood Establishments and Regulatory Authorities from Member States representing all WHO Regions International professional institutions and associations WHO Member States through WHO formal channels (e.g. Ministries of Health) Aug-Oct 2010 Oct 2010 pending Second consultation ECBS and ECSPP Adoption of new guideline by ECBS and ECSPP Official editing acc. WHO Style Guide and publication in the WHO Technical Report Series 7 7

8 Overall outcome from global consultation 653 constructive comments received 88 comments were for spelling or punctuation edits 565 comments that required minor content edits Most comments were for clarity and further guidance and not challenging the technical concept and content No comments challenged the main structure of the document Document generally well received 8 8

9 Structure of the document Chapters 1 2: Introduction, Glossary/Abbrev. Chapters 3 8: Quality Management Chapter 9: Chapter 10: Chapter 11: Chapter 12: Manufacturing Contract manufacturing, analysis and services Authors and Acknowledgments References 9 9

10 Chapters Quality Management Principles, Product Quality Review, Quality risk management, Change control, Deviation evaluation and reporting, CAPA, Internal audits, Complaints and product recall, Process Improvement, Look back - Personnel Organisation and responsibilities, Training, Personal hygiene - Documentation SOPs and records, Document control 10 10

11 Chapters 3 8 (cont.) - Premises and Equipment Premises, Equipment, Computerized systems - Qualification and Validation Qualification of equipment, Validation of manufacturing processes, Choosing of an appropriate test system, assay performance validation - Management of Materials and Reagents Materials and reagents, Receipt/Quarantine/Release/Storage/ Traceability of material, Supplier/Vendor management 11 11

12 Chapter 9 - Manufacturing - Process-specific guidance Donor registration, Donor selection, Collection, Component preparation, Laboratory testing, Quality monitoring, Labelling, Release, Storage, Distribution, Shipping, Returns - Product characteristics Whole blood, Red cells, Platelets, Plasma for transfusion/fractionation, Cryoprecipitate/CPP - Points to consider for validation of preparation steps Centrifugation, Separation, Freezing, Leukocyte reduction, Irradiation 12 12

13 Good manufacturing practice (GMP) GMP is an integral part of Quality Assurance which ensures that products are consistently produced and controlled to the quality standards GMP principles are based on a long experience to control medicines manufacture GMP is a proactive and reactive manufacturing control model GMP is a risk-based approach EU-PIC/S GMP Annex 20: Quality Risk Management (ICH) 13

14 Quality management from donor to patient plasma Manufacture of plasmaderived medicinal products donors Blood collection and component preparation Treatment of patients Blood Establishment Therapeutic products either for direct transfusion or for further manufacturing Good manufacturing practice for collection and component preparation Industrial manufacturer Therapeutic medicinal products High safety and quality level through specific manufactoring steps Harmonised Good Manufactoring Practice standards Hospital Medical activity No common Good Transfusion Practice 14

15 Impact of WHO Guidelines on GMP in Blood Establishments Improvement of quality related aspects in blood establishments globally. Implementation of GMP:» supports systematic application of donor selection criteria» ensures appropriate testing methods and testing kits, and use of suitable reagents» requires the use of suitable facilities, equipment and materials» reduces errors and technical problems» ensures the existence of validated and robust processes» guarantees the release of products which comply with the safety and quality requirements» ensures adequate documentation and full traceability» strengthens the competence of the personnel» enables continuous improvement Other aspects of implementation of GMP:» economic considerations, e.g. less waste, errors,» increases availability of plasma of assured quality 15

16 Impact of WHO Guidelines for GMP in Blood Establishments (cont.) Influence and support control activities (e.g. inspections) of NRA s Further promotion of document by professional organisations (e.g. ISBT,..) and plasma industry associations Influence on the development or revision of other related international documents, e.g. WHO: Complementary to other documents Council of Europe: Revision of Chapter 1 of the Guide to the preparation, use and quality assurance of blood components EU: Good Practice Guidelines based on Blood Directive 2002/98/EC and the Quality System Requirements (2005/62/EC) (pending) Revision of EU GMP annex 14 for manufacturing of blood products (under revision) PIC/S: Revision of PIC/S GMP annex 14 Revision of PIC/S GMP guide for blood establishments (PE 005-3) 16

17 Impact of WHO Guideline for GMP in Blood Establishments (cont.) A significant volume of plasma collected in developing countries is discarded because of: Lack of appropriate technology and expertise Lack of controls: unmet quality criteria for fractionation Lack of GMP implementation in blood establishments GMP implementation in blood establishments is a key element to Quality and safety of plasma for fractionation Plasma contract fractionation programs 17

18 Conclusion (I) GMP is mandatory for plasma-derived products. GMP principles can easily be applied in non-industrial manufacturing processes. They should also be applied in blood establishments. Strict adherence to GMP principles is a main element for quality and safety of blood products. GMP principles must be designed into the processes and not added afterwards or tested into it. GMP implementation is supporting plasma contract fractionation programs and global access to blood products. 18

19 Conclusion (II) New document provides a new chance for global harmonisation of quality system requirements for blood establishments based on GMP. New document will strengthen national / regional blood regulatory authorities and promote regional cooperation. 19

20 Thank you for your attention! 20