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YEMEN |
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Authority |
Ministry of Public Health |
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website |
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if any |
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DOSSIER REQUIRMENTS |
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INDEX |
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S.No |
Documents |
Page no |
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1. |
Composition formula both qualitative and quantitative |
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2. |
Specifications of all raw materials |
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3. |
Methods of testing |
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4. |
Brief description of product development |
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5. |
Brief description of manufacturing procedure including validation |
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6. |
Critical in-process control methods |
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7. |
Finished product specifications |
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8. |
Methods of testing of finished product |
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9. |
Assay method validation |
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10. |
Stability studies including accelerated at 400C/75%RH for 6 months and long-term at 300C/65%RH covering the proposed shelf-life on 3 batches. |
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11. |
Specifications of packaging materials |
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12. |
Samples of the finished products (to be given later) |
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13. |
Certifacte of analysis of products ( of the submitted samples) |
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14. |
Certificate of CPP as per the WHO format |
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15. |
Certificate of freedom from SPE (cow madness) as applicable |
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Toc for yemen, toc formate for dossier
