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SCRUTINY OF PROTOCOLS:
1. SUMMARY OF THE FINISHED DIAGNOSTIC KIT:
1.1 |
Name of the Diagnostic Kit
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1.2 |
Name and address of manufacturer / Telephone/ Fax No., e-mail ID |
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1.3 |
Name and address of supplier/ Telephone/ Fax No., e-mail ID |
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1.4 |
Details of Batch manufactured
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1.5 |
Date of manufacturing
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1.6 |
Date of Expiry |
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1.7 |
Storage temperature |
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1.8 |
Details Manufacturing/ Import
license issued valid up to
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1.9 |
Detail of the component of the kit and configuration of the kit |
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2. DETAILS OF MATERIALS:
2.1
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Source of Individual components
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2.2 |
Composition of Individual components
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2.3 |
Characterization record of Ag/Ab
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2.4 |
Record of Process Control of Coating of Antigen / Antibody on the matrix |
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2.5 |
Record of in process QC
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2.6 |
Record of in house evaluation of Sensitivity, Specificity and Stability data |
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2.7 |
Name of the three countries where they are being marketed
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2.8 |
QC report of all component of kit |
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2.9 |
Batch Release certificates from NRA (NRA- National Regulatory Authority)
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3.0 |
Specific processing like safe handling, material control, material safetydata sheet, area control, storage at quarantine stage and finish stage. |
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Certificate
The information submitted above is true to best of my knowledge and belief.
Place: Signature of the manufacture Date: Seal/Stamp
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