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Good Manufacturing Practices for Blood Establishments (GMP for plasma donations)

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. OUTLINE. OUTLINE. The GMP concept Good Manufacturing Practices for BE GMP compliance

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Good Manufacturing Practices for Blood Establishments (GMP for plasma donations)

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  1. 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

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

  3. 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

  4. WHA63.12: "Blood Products" definition "Any therapeutic substances derived from human blood, including whole blood, labile blood components and plasma-derived medicinal products"

  5. WHAT DO WE NEED TO ACHIEVE THROUGH GMP? • CONTROL INHERENT BIOLOGICAL VARIABILITY* • CONSISTENCY OF PRODUCTION/PROCESSES • TRACEABILITY DONOR RECIPIENT * each individual donation is unique

  6. 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

  7. 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

  8. TRACEABILITYFROM DONOR TO PATIENT Blood donation Blood Components Patients Plasma-Derived Medicinal Product Plasma for Fractionation FRACTIONATION VIRAL INACTIVATION DONOR INFORMATION COMPONENTS SEPARATION TREATMENT Good Manufacturing Practices

  9. TRACEABILITYFROM 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

  10. 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

  11. Plasma Contract Fractionation Programs- Need for GMP implementation in BE - Nat.Reg. Authority Nat.Reg. Authority PLASMA SUPPLIER FRACTIONATOR GMP- common principles GMP Licensing Quality Assurance Program GMP Licensing Plasma Contract fractionation across countries

  12. FROM DONOR TO PATIENT Blood/Plasma donation Blood Components Patients Plasma-Derived Medicinal Product Plasma for Fractionation FRACTIONATION VIRAL INACTIVATION COLLECTION PROCESS COMPONENTS PREPARATION TREATMENT TRACEABILITY LOOK BACK SYSTEM

  13. Good Manufacturing Practices (GMP) for Blood establishments (BE): Definition GMP is that part of QUALITY ASSURANCE that ensures that products are consistently producedto the quality standards appropriate to their intendeduse, as requiredby predefined specifications and, if applicable, by the marketing authorisation. GMP is concerned with bothproduction and quality control. WHO Guidelines for Blood Establishments (TRS 961, Annex 4): http://www.who.int/entity/bloodproducts/publications/GMP_Bloodestablishments.pdf

  14. GMP compliance: issues specific to the production of blood components, including plasma for fractionation

  15. 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

  16. Structure of the Document Chapters 1 – 2: Introduction, Glossary/Abbrev. Chapters 3 – 8: Quality Management Chapter 9:Manufacturing Chapters 10: Contract manufacturing, analysis and services Chapters 11 - 12: Acknowledgements/References

  17. Chapters 3 – 8 • Quality Management • Principles, Product Quality Review, Quality risk management, Change control, Deviation evaluation and reporting, Corrective and preventive actions, Internal audits, Complaints and product recall, Process Improvement, Look back • Personnel • Organisation and responsibilities, Training, Personal hygiene • Documentation • SOP and records, Documentation control

  18. Chapters 3 – 8 (cont.) • Premises and Equipement • Premises, Equipment, Computerized-systems • Qualification and Validation • Qualification of equipment, Validation of manufacturing processes, selection of an appropriate test system, Assay performence validation • Management of Materials and Reagents • Materials and reagents, Receipt/Quarantine/Release/Storage/Traceability of material, Supplier/Vendor management

  19. Chapter 9: Manufacturing • Process-specific guidance • Donor registration, Donor selection, Collection, Component preparation, Laboratory testing, Quality control, Labelling, Release, Dispatch, Shipping, Returns • Product characteristics • Whole blood, Red cells, Platelets, plasma for transfusion, plasma for fractionation, Cryoprecipitate/CPP • Points to consider for validation of production steps • Centrifugation, Separation, Freezing, Leukocyte reduction, Irradiation

  20. GMP compliance....... the principle • The production process must • Be validated • Be reproducible • Be clearly specified and documented • Be in accordance with the licensed process (at all times) • Change must be managed • Planned change(s) should be controlled • Unplanned changes (deviations) should be • Recorded • Reviewed for impact on product Safety, Quality and Efficacy

  21. GMP compliance…… plasma variability • A robust (standardized) process required • Knowledge of the production process competence needed: • Knowledge of the plasma characteristics • Knowledge of impact on processes and products • Process optimization for those characteristics • Process documentation: change control to manage modifications • Trend analysis to monitor the process (behaviour over time)

  22. GMP compliance …the culture inside the organization The culture of the organisation should encourage: • respect for the defined process • respect for the planned change mechanism • openness in timely reporting of deviations • commitment to determine variation cause • recognition of the benefits of trend analysis • determination to learn from past mistakes

  23. SUMMARY Suitability of plasma depends on meeting production standards for blood collection and component manufacturing control of processes end-to-end required for production of all blood components

  24. IMPACT OF GMP IN BLOOD ESTABLISHMENTS (I) • In blood establishments, GMP introduces the application ofquality assurance principles in all stepsinvolved in the collection, production and testing of blood components • GMP supports systematic application of donor selectioncriteria for each donation • GMP reduces errors and technical problems in collection, production, testing, and distribution

  25. IMPACT OF GMP IN BLOOD ESTABLISHMENTS (III) • Implementation of GMP in blood establishments has shown to be a beneficial tool to help countries in improving plasma quality • GMP in blood establishments will increase availability of plasma and is one of the key issues for a successful plasma contract fractionation program and/or domestic fractionation

  26. WHO guidance documents: website addressed www.who.int/bloodproducts • Reference on GMP for blood establishments (2011): http://www.who.int/entity/bloodproducts/publications/GMP_Bloodestablishments.pdf • Reference on production, control and regulation of plasma for fractionation (2007): http://www.who.int/entity/bloodproducts/publications/TRS941Annex4blood.pdf • Reference on viral inactivation and removal procedures (2005): http://www.who.int/entity/bloodproducts/publications/GMP_Bloodestablishments.pdf • Catalogue of blood products and blood safety related reference materials: http://www.who.int/bloodproducts/catalogue/en/index.html

  27. http:// www.who.int/bloodproducts

  28. Web site addresses http://www.who.int/bloodproducts http://www.who.int/bloodproducts/catalogue

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