WHO Guidelines On GMP For Blood Establishments | Annex 4

WHO Guidelines On Good Manufacturing Practices For Blood Establishments, WHO TRS 961, 2011 Annex 4

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TABLE OF CONTENTS

1. Introduction

2. Glossary and abbreviations

3. Quality management

    3.1 Principles

    3.2 Quality assurance

          3.2.1 Good manufacturing practice in blood establishments

          3.2.2 Quality control

    3.3 Product quality review

    3.4 Quality risk management

    3.5 Change control

    3.6 Deviation evaluation and reporting

    3.7 Corrective and preventive actions

    3.8 Internal audits

    3.9 Complaints and product recall

          3.9.1 Complaints

          3.9.2 Recalls

    3.10 Process improvement

    3.11 Look-back

4. Personnel

    4.1 Organization and responsibilities

    4.2 Training

          4.2.1 Initial training

          4.2.2 Continuous training

          4.2.3 Competency

    4.3 Personal hygiene

5. Documentation

    5.1 Standard operating procedures and records

          5.1.1 Standard operating procedures

          5.1.2 Records

    5.2 Document control

          5.2.1 Document management

          5.2.2 Record retention and archiving

6. Premises and equipment

    6.1 Premises

          6.1.1 Design and construction

          6.1.2 Donor areas

          6.1.3 Production areas

          6.1.4 Storage areas

          6.1.5 Laboratories

          6.1.6 Mobile collection sites

    6.2 Equipment

          6.2.1 Design and construction

          6.2.2 Maintenance

          6.2.3 Cleaning

          6.2.4 Calibration

    6.3 Computerized systems

7. Qualification and validation

    7.1 Qualification of equipment

    7.2 Validation of manufacturing processes

    7.3 Choosing an appropriate test system to screen for infectious disease

    7.4 Assay performance validation

8. Management of materials and reagents

    8.1 Materials and reagents

    8.2 Receipt and quarantine

    8.3 Release of incoming production material and test reagents

    8.4 Storage

    8.5 Traceability of materials and reagents

    8.6 Supplier/vendor management

9. Manufacturing

    9.1 Donor registration

    9.2 Donor selection

          9.2.1 Epidemiological surveillance of the donor population

          9.2.2 Information to donors

          9.2.3 Questionnaire and interview

          9.2.4 Deferral policy and deferral criteria

          9.2.5 Physical examination, donor health criteria and donor acceptance

    9.3 Collection

          9.3.1 Whole blood collection

          9.3.2 Collection by apheresis

          9.3.3 Safety of donors

   9.4 Component preparation

         9.4.1 Starting material

         9.4.2 Methods of production

                  9.4.2.1 Centrifugation

                  9.4.2.2 Separation

                  9.4.2.3 Freezing

                  9.4.2.4 Leukocyte reduction

                  9.4.2.5 Irradiation

         9.4.3 Blood and blood components

                  9.4.3.1 Whole blood

                  9.4.3.2 Red-cell concentrate

                  9.4.3.3 Platelet concentrate

                  9.4.3.4 Plasma for transfusion and Plasma for fractionation

                  9.4.3.5 Cryoprecipitate and Cryo-poor plasma

   9.5 Laboratory testing

         9.5.1 Screening tests for infectious disease markers

                  9.5.1.1 Testing requirements

                  9.5.1.2 Handling of samples and data

                  9.5.1.3 Testing and post-analytical procedures

                  9.5.1.4 Test interpretation and follow-up of reactive results

         9.5.2 Blood group typing

         9.5.3 Retention samples

   9.6 Quality monitoring of blood and blood components

   9.7 Labelling

         9.7.1 Label information

         9.7.2 Product name

         9.7.3 Expiry date

   9.8 Release of product

   9.9 Storage

   9.10 Distribution

   9.11 Shipping

   9.12 Returns

10. Contract manufacturing, analysis and services

11. Authors and acknowledgements

12. References

WHO Guidelines On GMP For Blood Establishments | Annex 4