Infinium’s Quality Department has three key functional units – Quality Control, Quality Assurance and Regulatory Affairs, each with its own responsibilities:
Quality Control establishes procedures for quality control of incoming materials, in the process, intermediates, API and Drug Products. The state of the art quality control laboratories follow all the current guidelines for monitoring the strict quality of our products / analytical services.
Quality Assurance is responsible for implementing and monitoring of Quality Systems throughout the company. Quality Assurance ensures the continued compliance with GMP and regulatory requirements. Quality Assurance controls all the operations starting from the procurement of raw materials to production and shipping of products with scientifically based control systems.
Regulatory Affairs handles both National and International Regulatory Affairs.
- National Regulatory Affairs is responsible for licensing and compliance to all National Regulatory requirements for import, export, manufacturing & testing of products handled at Infinium.
- International Regulatory Affairs is responsible for filing all regulatory documents to various regulatory authorities as per the requirement of the clients and addressing all regulatory queries from clients & authorities.