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Quality Control Laboratory is
responsible for establishing procedures for assuring that
vaccines or biological products are of adequate safety and
efficacy. |
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Quality Control Laboratory is
responsible for the quality and integrity of the analytical
results and the associated reliability. |
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Sampling and testing of Raw
Materials, Packaging Materials. |
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Analysis of bulk and finished
products of vaccines, sera and ORS (Nimkol). |
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Sampling and testing of raw
water, purified water and WFI. |
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Tissue Culture maintenance and
preparation for testing of vaccines. |
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Preparation of Batch Analysis
Record (BAR) for Lot release of products from National
Regulatory Authorities (NRA). |
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Microbiological environmental
monitoring. |
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Calibration of instruments and
glassware's. |
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Validation of analytical
methods. |
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Reference sample collection,
preservation and destruction. |
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In House Reference standard
preparation and standardization |
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QC testing in laboratory
animals. |
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Stability study of vaccines. |
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Collaboration with national and
International organizations such as WHO, JICA etc. |
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Tetanus
Toxoid (Bulk & Final) |
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Allergy
Vaccine |
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TAB & TC
vaccine |
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Rabies
Vaccine (Bulk & Final) |
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Measles
vaccine (Basic, Bulk & Final) |
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Anti Rabies
Serum |
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Anti Snake
Venom Serum |
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Oral
Rehydration Salt (ORS) |
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Water For
Injection (WFI) |
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Raw material
(Chemicals) |
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Raw material
(Packaging Material) |
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GLP –
compliant equipments. |
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Well defined
Quality Systems with adequate controls.
|
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Independent
Quality Control laboratory to perform physical, chemical and
microbiological testing, fully equipped with
sophisticated instruments like : |
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Biohazard Safety Cabinet |
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CO2 Incubator |
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Karl Fisher Instrument |
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UV-Visible Spectrophotometer |
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Water Distillation Plant |
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Astell Horizontal Autoclave |
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Inverted Microscope |
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Cell Bank |
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Pyrogen Testing System |
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TOC Analyzer |
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Flame Photometer |
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In order to improve the
technical capabilities of QCL project is going on with JICA
collaboration; under this project 04 technical experts have
been trained in various areas of QC testing.
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QCL is working under the
following Programmes and Projects in collaborating with WHO
and JICA;