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Drug Substance

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Drug Substance
An active ingredient intended to furnish pharmacologic activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the body; it does not include intermediates used in the synthesis of such an ingredient


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Experts suggest that if a drug substance is produced in non GMP facility it can carry harmful toxic materials due to contaminations introduced through the processing in non clean air or low quality water or the cross contamination of different chemicals used in the facility or can carry harmful bacteria or viruses which can be introduced from any source even the operators working in the manufacturing facility can be source of contamination if they carry disease.
Experts suggest that if a drug substance is produced in non GMP facility it can carry harmful toxic materials due to contaminations introduced through the processing in non clean air or low quality water or the cross contamination of different chemicals used in the facility or can carry harmful bacteria or viruses which can be introduced from any source even the operators working in the manufacturing facility can be source of contamination if they carry disease.
It facilitates continual improvement, he said, and also applies to drug substance and drug product throughout he the product lifecycle.
 
 
 
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