WHO Technical Report Series, No. 981 - World Health Organization

Annex 3
WHO guidelines on variations to a prequalified product
Introduction 96
1. Background 97
1.1 Objectives 97
1.2 Scope and application 98
2. Guidance for implementation 99
2.1 Reporting types 99
2.1.1 Notifications 100
2.1.2 Minor variation (Vmin) 101
2.1.3 Major variation (Vmaj) 101
2.1.4 New applications and extension applications 101
2.1.5 Labelling information 101
2.2 Conditions to be fulfilled 101
2.3 Documentation required 102
3. Glossary 102
4. Administrative changes 104
1. Change in the name and/or corporate address of the supplier of the FPP 104
2. Change in the name or address of a manufacturer of an API that is not a supplier
of a prequalified API or that is not supported by a CEP 105
3. Change in the name and/or address of a manufacturer of the FPP 105
4. Deletion of a manufacturing site or manufacturer 105
5. Changes to a CEP or to a confirmation of API-prequalification
document 106
5. Submission of a new or updated CEP for an API or starting material or
intermediate used in the manufacturing process of the API 106
6. Submission of a new or updated confirmation of API-prequalification document 107
7. Submission of a new or updated transmissible spongiform encephalopathy
(TSE) CEP for an excipient or API (addition or replacement) 108
6. Quality changes 108
3.2. S Drug substance (or API) 108
3.2. S.2 Manufacture 108
8. Replacement or addition of a new manufacturing site or manufacturer of an API 108
9. Change or addition of a manufacturing block or unit at a currently accepted site
of API manufacture 112
10. Change in the manufacturing process of the API 112
11. Change in the in-process tests or limits applied during the manufacture of the API 114
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