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GMP on blood/plasma collection establishments

GMP on blood/plasma collection establishments . Group 2. Outlines . Inspected site General observation. Major issues Summary . Blood collection unit. Flow system: starting materials – donor finished product -- collected blood bag

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GMP on blood/plasma collection establishments

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  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 finished product -- collected blood bag • Aims uncontaminated identified blood bags.

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

  5. Premise and equipment • Control access. • Facility suit operation. Apparatus Storage area • Surface permit effective cleaning. floor, walls, and ceiling • Qualification and validation. Apparatus. Calibration 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. • Back up power supply • Small layout. • Fire extinguisher • Absence of privacy • Post donation care • Bag ceiling

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

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

  13. B. preparation area • 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

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

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