Administering Files, Records, and Grants

Table of Contents

1 Introduction

2 International Biological Reference Preparations

3 Glossary

4 General considerations

4.1 Range of products made from human blood and plasma

4.2 Composition of human plasma

4.3 Pathogens present in blood and plasma

5 Measures to exclude infectious donations

5.1 Appropriate selection of blood/plasma donors

5.2 Screening of blood/plasma donations for infectious markers

5.3 Epidemiological surveillance of donor population

5.4 Strict adherence to Good Manufacturing Practices

5.5 Post-donation events

6 Production of plasma for fractionation

6.1 Methods used to obtain plasma for fractionation

6.2 Characteristics of plasma for fractionation

6.3 Premises and devices for collection of plasma for fractionation

6.4 Blood/plasma collection process

6.5 Separation of plasma

6.6 Freezing of plasma

6.7 Storage of plasma

6.8 Compliance with plasma fractionator requirements

6.9 Release of plasma for fractionation

6.10 Packaging of plasma

6.11 Transportation of plasma

6.12 Recall system

7 Quality assurance system and Good Manufacturing Practices

7.1 Organisation and personnel

7.2 Documentation system

7.3 Premises and equipment

7.4 Materials

7.5 Validation programme

7.6 Quality monitoring data

7.7 Virology safety testing

7.8 Electronic information system

7.9 Storage and transport

7.10 Change control system

7.11 Quality assurance auditing

7.12 Defect reporting system

7.13 Quality agreement between blood establishment and fractionator

7.14 Blood/plasma establishment audit and inspection

8 Regulatory control of plasma for fractionation

8.1 Role of national regulatory authority

8.2 Establishment licence and inspections

8.3 Impact of Good Manufacturing Practices

8.4 Inspections

9 Authors

10 Appendices

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