GMP on blood/plasma GMP on blood/plasma collection establishments collection establishments

Group 2Group 2

Outlines Outlines

Inspected siteInspected site General observation.General observation. Major issues Major issues Summary Summary

Blood collection unitBlood collection unit

Flow system:Flow system: starting materials – donorstarting materials – donor finished product -- collected blood bagfinished product -- collected blood bag

Aims uncontaminated identified Aims uncontaminated identified blood bags.blood bags.

Identification Identification Educational materials. Educational materials. Valid IDValid ID Centrally computerized networkCentrally computerized network Donation numberDonation number

Unique numberUnique number TraceabilityTraceability Ethical issues:Ethical issues: pre donation counselingpre donation counseling consentconsent confidentiality confidentiality notification of results notification of results

Premise and equipment Premise and equipment

Control access. Control access. Facility suit operation.Facility suit operation.

Apparatus Apparatus

Storage areaStorage area Surface permit effective cleaning.Surface permit effective cleaning.

floor, walls, and ceiling floor, walls, and ceiling Qualification and validation.Qualification and validation.

Apparatus. Calibration Apparatus. Calibration

procedure e.g. work technique, cleaning, etc procedure e.g. work technique, cleaning, etc

Quality Quality assurance assurance

Carried out independently.Carried out independently. Irregularly. Irregularly.

DocumentatiDocumentation on QualificationQualification Validation Validation

Personnel. Personnel.

Risk management. Risk management.

Transportation Transportation

Packaging (ice box). Packaging (ice box). Three time a day.Three time a day.

Observation Observation

• Emergency exist.Emergency exist.

• Back up power supplyBack up power supply

• Small layout.Small layout.

• Fire extinguisher Fire extinguisher

• Absence of privacy Absence of privacy

• Post donation carePost donation care

• Bag ceiling Bag ceiling

LaboratoryLaboratory(blood bank) (blood bank)

Premises and equipment. (Premises and equipment. (flow system, storage area, flow system, storage area, qualifications, validation, calibration, automated and semi qualifications, validation, calibration, automated and semi automated. automated.

Receiving of sample. Receiving of sample.

Personnel.Personnel. QAQA Risk managementRisk management Documentation Documentation

A. Testing area

Observation Observation

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

Premises and equipment. (flow system, Premises and equipment. (flow system, storage area, qualifications, validation, storage area, qualifications, validation, calibration, calibration,

Release of test results. (authorization, Release of test results. (authorization,

Personnel (qualification, training, medical Personnel (qualification, training, medical check up, check up,

Transportation (qualified, validated, Transportation (qualified, validated, QAQA Risk managementRisk management DocumentationDocumentation

B. preparation area

Summary Summary

• Establishments and improvement of Establishments and improvement of blood transfusion establishment. blood transfusion establishment.

• GMP GMP

• Regulatory system.Regulatory system.

• Fractionation plasma Fractionation plasma