GMP on blood/plasma collection establishments

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