Corporate Quality Assurance and Regulatory Affairs ::

The primary function includes assuring compliance with GLP, GCP and GMP requirements, implementation of quality systems, inspections and checks during the design and development of pharmaceutical products. International regulatory operations including compilation of dossiers for abridged ANDA - Abbreviated New Drug Application/DMF - Drug Master File/NDA - New Drug application and submissions.

Torrent quality is mandated and supported by Executive Management and coordinated by an independent Corporate Quality Assurance (CQA) Department.

Major Functions ::

CQA ensures quality in Research & Development, Production, and Quality Control & Distribution of Torrent Pharmaceutical products. It assures that quality is built into Torrent products from their development in R&D. Also provides continued support by product design and modification of both, API & Formulations, ensuring that R&D processes comply with the latest guidelines of GLP, GMP & GCP.

Corporate Quality Assurance is also responsible for ensuring the quality of all input materials. For this, regular audits and follow up is done on Raw & Packaging Materials suppliers. Regular employees training on GLP, GMP & GCP is coordinated by CQA.

Regulatory Affairs Division of CQA is responsible for registration of products in different countries. It keeps up to date with requirements of various countries and coordinates development of data for registration requirements for both, regulated and non-regulated countries.