WHO TRS 986, 2014 Annex 3

WHO TRS (Technical Report Series) 986, 2014 Annex 3

Model quality assurance system for procurement agencies

Click on the any titles below for complete guidelines

TABLE OF CONTENTS

Glossary 

Module I

 

General requirements for procurement agencies 

I.1 Introduction 

I.2 Physical resources 

I.2.1 Premises 

I.2.2 Equipment 

I.2.3 Vehicles and transport 

I.2.4 Financial systems 

I.2.5 Human resources 

I.3 Documentation of policies and standards 

I.3.1 Quality manual 

I.3.2 Standard operating procedures 

I.3.3 Change control policy and handling of variations 

I.3.4 Code of conduct 

I.3.5 Guidelines on conflict of interest 

I.3.6 List of prequalified products, manufacturers and suppliers 

I.3.7 Maintenance of records 

I.3.8 Contract arrangements 

Module II 

Prequalification 

II.1 Introduction 

II.2 Principles for prequalification

II.2.1 WHO Model List of essential medicines 

II.2.2 Standards for prequalification 

II.2.3 Key persons and responsibilities 

II.2.3.1 Staff responsible for prequalification 

II.2.3.2 Staff responsible for evaluation of product information 

II.2.3.3 Staff responsible for inspection of manufacturing sites 

II.2.4 Key steps in prequalification 

II.2.4.1 Step 1: Soliciting information 

II.2.4.2 Step 2: Receive product information 

II.2.4.3 Step 3: Screen product information 

II.2.4.4 Step 4: Evaluate product information 

II.2.4.5 Step 5: Plan, prepare and perform inspections 

II.2.4.6 Step 6: Finalize assessment process 

II.2.5 Requalification and monitoring 

II.2.6 Monitoring of complaints 

II.2.7 Cost recovery 

II.3 List of suggested SOPs 

Module III 

Purchasing 

III.1 Introduction 

III.2 Procurement strategies 

III.3 Procurement methods 

III.3.1 Restricted tender 

III.3.2 Competitive negotiation 

III.3.3 Direct procurement 

III.3.4 Open tender 

III.4 Quality assurance in purchasing 

III.5 Key activities in purchasing 

III.5.1 Develop a list 

III.5.2 Quantification 

III.5.3 Procurement method 

III.6 Organization and responsibilities 

III.7 Monitoring of performance of prequalified manufacturers 

III.8 Country legislation 

III.9 Donations 

III.10 List of suggested SOPs 

Module IV 

Receipt and storage of purchased products 

IV.1 Introduction 

IV.2 Pre-shipment quality control 

IV.3 Receipt of stock 

IV.4 Post-procurement quality control 

IV.4.1 Sampling 

IV.4.2 Rejected materials 

IV.5 Storage of materials and products 

IV.5.1 Staff 

IV.5.2 Storage areas 

IV.5.3 Storage conditions 

IV.5.4 Repacking and relabeling 

IV.5.5 Miscellaneous and hazardous materials 

IV.5.6 Stock control 

IV.5.7 Documentation: written instructions and records 

IV.6 List of suggested SOPs 

Module V 

Distribution 

V.1 Introduction 

V.2 Transport conditions 

V.3 Cold chain 

V.4 Temperature monitoring and records 

V.5 Delivery order 

V.6 Dispatch procedures and policies 

V.7 Dispatch containers 

V.8 Dispatch records 

V.9 Traceability 

V.10 Port of entry 

V.11 List of suggested SOPs 

Module VI 

Reassessment 

VI.1 Introduction 

VI.2 Reevaluation of manufacturers 

VI.3 Reevaluation of products 

VI.4 Monitoring of contracted services 

VI.5 List of suggested SOPs 

References 

Appendix 1. Example of a code of conduct 

Appendix 2. Example of a guideline on confidentiality 

Appendix 3. Example of a guideline on conflict of interest 

Appendix 4. Example of a standard operating procedure (SOP) for writing an SOP 

Appendix 5. Example of an invitation for expression of interest 

Appendix 6. Interagency finished pharmaceutical product questionnaire based on the model quality assurance system for procurement agencies 

Appendix 7. Example of a standard operating procedure for screening and assessing product information 

Appendix 8. Quality systems recommendations for pharmaceutical inspectorates 

Appendix 9. Technical questionnaire for pharmaceutical manufacturers 

Appendix 10. Example of a standard operating procedure for planning of inspections 

Appendix 11. Example of a standard operating procedure for preparing for an inspection 

Appendix 12. Example of a standard operating procedure for performing an inspection 

Appendix 13. Example of a checklist for good manufacturing practices 

Appendix 14. Guidance on good manufacturing practices: model inspection report 

Appendix 15. Good storage practices 

Appendix 16. Good trade and distribution practices

WHO TRS (Technical Report Series) 986, 2014 Annex 3: