1 / 14

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

odessa
Download Presentation

GMP on blood/plasma collection establishments

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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

More Related