WHO TRS (Technical Report Series) 961, 2011 Annex 4
WHO Guidelines On Good Manufacturing Practices
For Blood Establishments
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TABLE OF CONTENTS
3.2.1 Good manufacturing practice in blood establishments
3.6 Deviation evaluation and reporting
3.7 Corrective and preventive actions
3.9 Complaints and product recall
4.1 Organization and responsibilities
5.1 Standard operating procedures and records
5.1.1 Standard operating procedures
5.2.2 Record retention and archiving
7. Qualification and validation
7.1 Qualification of equipment
7.2 Validation of manufacturing processes
7.3 Choosing an appropriate test system to screen for infectious disease
7.4 Assay performance validation
8. Management of materials and reagents
8.3 Release of incoming production material and test reagents
8.5 Traceability of materials and reagents
8.6 Supplier/vendor management
9.2.1 Epidemiological surveillance of the donor population
9.2.3 Questionnaire and interview
9.2.4 Deferral policy and deferral criteria
9.2.5 Physical examination, donor health criteria and donor acceptance
9.4.3 Blood and blood components
9.4.3.4 Plasma for transfusion and Plasma for fractionation
9.4.3.5 Cryoprecipitate and Cryo-poor plasma
9.5.1 Screening tests for infectious disease markers
9.5.1.2 Handling of samples and data
9.5.1.3 Testing and post-analytical procedures
9.5.1.4 Test interpretation and follow-up of reactive results
9.6 Quality monitoring of blood and blood components
10. Contract manufacturing, analysis and services
11. Authors and acknowledgements
WHO TRS (Technical Report Series) 961, 2011 Annex 4