"IIIM Jammu is in the process of creating a State-of-Art National Facility for small and medium scale manufacturers from north India and the state of J&K in particular to get their products manufactured under GMP/GLP conditions besides its use for research in IIIM" ...

About cGMP


IIIM Jammu has created a State-of-the-Art National Facility for small and medium scale manufacturers from north India and the state of J&K in particular to get their products manufactured under GMP/GLP conditions besides its use for research in IIIM. In 2007, CSIR-IIIM started a project to set up cGMP Herbal Drugs extraction unit with the financial assistance of CSIR under Network project. The infrastructure for setting up the facility involved the existing building site at IIIM Jammu.

The plant was designed by Chemical Engineering Division of IIIM and fabrication and installation work was carried out by M/s Bio-Chem Engineers- Pune on turnkey basis. Before the completion of the project, it was thought desirable to also include Formulation and Packaging unit.

A new project was framed under National Facility project under Drugs and Pharmaceuticals Research Programme (DPRP) of Department of Science and Technology (DST, Govt of India) entitled 'cGMP pilot plant for Extraction, Formulation and Packaging of Traditional (ISM) Herbal Medicinal Formulations" , with DST, AYUSH and CSIR/IIIM as the funding agencies. The necessity to have such a project was found compulsory so as to generate sufficient data for effective regulation and control of herbal / traditional medicines moving into international commerce with standardized authentic materials.

The facility is to cater to the needs of IIIM in terms of preparation of extracts, their formulations in the form of a tablet/capsule/liquid, for pre-clinical and clinical trials of the NCEs derived from botanicals and also other probable NCEs that are being evaluated for IND potential.

The cGMP, facility having the capacity to produce 30,000 tablets & capsules per hour, and 500 litres of liquid per batch on pilot scale basis.

 

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