1. GMP on blood/plasma collection establishments Group 2

2. Outlines  Inspected site  General observation.  Major issues  Summary

3. Blood collection unit  Flow system: starting materials – donor starting materials – donor finished product -- collected blood bag finished product -- collected blood bag Aims uncontaminated identified Aims uncontaminated identified blood bags. blood bags.

4. Identification  Educational materials.  Valid ID  Centrally computerized network Donation number Donation number Unique number Unique number Traceability Traceability  Ethical issues: pre donation counseling pre donation counseling consent consent confidentiality confidentiality notification of results notification of results

5. Premise and equipment  Control access.  Facility suit operation. Apparatus Apparatus Storage area Storage area  Surface permit effective cleaning. floor, walls, and ceiling floor, walls, and ceiling  Qualification and validation. Apparatus. Calibration Apparatus. Calibration procedure e.g. work technique, cleaning, etc procedure e.g. work technique, cleaning, etc

6. Quality assurance  Carried out independently.  Irregularly.

7. Documentation  Qualification  Validation

8.  Personnel.  Risk management.

9. Transportation  Packaging (ice box).  Three time a day.

10. Observation Emergency exist. Emergency exist. Back up power supply Back up power supply Small layout. Small layout. Fire extinguisher Fire extinguisher Absence of privacy Absence of privacy Post donation care Post donation care Bag ceiling Bag ceiling

11. Laboratory (blood bank)  Premises and equipment. ( flow system, storage area, qualifications, validation, calibration, automated and semi automated.  Receiving of sample.  Personnel.  QA  Risk management  Documentation A. Testing area

12. Observation  Receiving of the sample.  Doing RPR in the receiving  Expiry kits in the refrigerator.  Visual validation for some test.

13.  Premises and equipment. (flow system, storage area, qualifications, validation, calibration,  Release of test results. (authorization,  Personnel (qualification, training, medical check up,  Transportation (qualified, validated,  QA  Risk management  Documentation B. preparation area

14. Summary Establishments and improvement of blood transfusion establishment. Establishments and improvement of blood transfusion establishment. GMP GMP Regulatory system. Regulatory system. Fractionation plasma Fractionation plasma