Pharma Philics

Sponsored Links

VIRAL ASSAYS!!!

A range of assay methods are used to detect viral contaminants in the raw materials and final finished products. It is obvious that a single viral assay cannot detect the entire viral types present in the sample. So how can we actually determine the viral contaminants. The strategy developed is simple. It mainly focuses on the possible viral contaminant of the source material being used. Also it does not include newly discovered or unknown viral contaminants. Current viral assays falls into 3 categories. 1. Immunoassays 2. Assays based on viral DNA probes

ICH Guidelines!!

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use which we simply refer as ICH is a distinct in getting together the various "regulatory authorities and pharmaceutical industry" of Japan, Europe and US to discuss about various scientific and technical requirements of drug registration.

You May Also Like..