Naresh Gorle

Background

About Naresh Gorle

Prepared documents for DCGI, CDSCO / DCA submissions and involved in DCGI audit. Involved in getting approval for Coagulation Factor IX, Factor and Fibrin Sealant Kit from NIB. Method Development and analytical method validations of finish product testings as per EP and IP. Involving in finish product release testings as per EP and IP. For Human IVIG, Human Albumin, Coagulation Factor IX, Coagulation Factor and Fibrin Sealant Kit Involved in preparation of product characterization document for Human Albumin and Human IgG for regulatory compliance. Developed Sodium Caprylate Quantification by RP HPLC in finished product Development and Qualification of Quantitative analysis of HBs Ag Abs, in IVIG and Hep B Immunoglobulin. Planning, Execution, documentation & trending of stability studies for IVIG, HAS and FIX as per ICH Guidelines Calibration of HPLC, UV-Visible Spectrophotometer, pH meter, weighing balance and Micropipettes. Responsible for new analytical instrument and equipment qualifications. And trouble shooting of HPLC, Kjeldahl Instruments. IQ,OQ & PQ Qualifications : Involved in Qualifications of Various Instruments like HPLC, Kjeldahl, UV Spec, Osmometer, ELISA Reader, Weighing balance, pH Meter, Nephelometer, Coagulometer, Centrifuge (Eppendorf), SDS & Western Blot. Performed AT activity assay by Chromogenic method and Heparin binding fraction assay (EP 7.0).