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| Our products are available in
blister packs and aluminium foil strips. All our
products undergo strict quality control procedures before they are released in the market.
Testing of RM, PM, BULK, WFI, Inprocess & Finished products are carried out by:
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Chemical Analysis |
|
Instrumental Analysis – includes
Spectrophotometry, Polarimetry, Chromatography (TLC, HPLC etc.) |
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Physical Analysis |
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Microbiological Analysis |
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Pharmacological Analysis |
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Biochemical Analysis |
Special Testing
procedures include:
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Lal Testing (Bacterial Endotoxin Test) |
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Sterility Testing |
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Implantation Testing |
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HPLC – High Performance Liquid
Chromatography Testing |
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Liquid Borne Particulate Matter-Counting
/ Sizing on special imported instrument |
Quality,
the main criteria of a product mainly depends on:
|
Selection and control of drug component
– RM/PM |
|
For parental products quality –
special processing of water system is required including demineralization / multistage
distillation to get high quality WFI. |
|
Manufacturing environmental control
– giving special class room facilities – class 100 for filling and critical
areas. Class 10,000 for other operations – to control of air borne particulate matter
and micro organizms. |
|
Proper selection of filtration system
– to control liquid borne particulate matter. |
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Selection and control of sterilization
methods – to control viable micro organisms. |
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Selection of proper labelling and
packaging – to meet drug regulation / market acceptance. |
Till date we have
achieved:
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Certificate of good manufacturing
practices as per world health organization. |
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ISO 9002
certification from SGS Yarsley U.K. |
|
Certification of good
manufacturing practices for large volume parentals in plastic containers and in glass
containers according to rules of Eudratex from National Institute of Pharmacy, Hungary. |
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