Quality & Regulatory

Current Good Manufacturing Practices (cGMP)

SM BIOMED GMP vertical has three key functional units — Quality control (QC), Quality assurance (QA) and Regulatory affairs (RA), each with its own responsibilities.

Quality Control

Quality control establishes procedures for incoming materials, in process, intermediates and APIs. Our quality control laboratories follow all the current guidelines for monitoring high standards of all our products.

Quality Assurance

Quality assurance is responsible for implementing and monitoring quality systems throughout the company. It ensures continual compliance with cGMP and regulatory requirements. The Quality Management System (QMS) is updated regularly based on new regulations and evolving compliance requirements to guarantee that operations comply with Current Good Manufacturing Practices (cGMP).

It also controls all operations starting from procurement of raw materials to production and shipping of products.

Regulatory affairs (RA)

The Regulatory affairs department is responsible for obtaining the necessary drug regulatory licenses as well as accreditations wherever required. RA authors the dossiers and prepares regulatory communications as and when required.