Ethical manufacturing key to medicine quality: GITAM Pharmacy Principal

The quality of medicines cannot be judged by end users and depends entirely on ethical manufacturing practices and strong lifecycle management, said Prof. L. Srinivas, Principal of the School of Pharmacy at GITAM Deemed to be University, at an awareness programme held on Wednesday. The programme, organised in collaboration with Chromachemie Laboratory Private Limited, focused on the role of the United States Pharmacopeia (USP) in setting global quality standards for medicines, dietary supplements, and foods.

Prof. Srinivas highlighted that USP had established the first quality system for medicines much before the formation of the U.S. Food and Drug Administration in 1906. He noted that current quality standards extend beyond drug content to include purity, impurity profiling, process-related impurities, stability, metabolomics, and genotoxicity.

Ms. Varsha Gowal, Senior Director (Regional Program Operations), USP, delivered a special session on “USP Vision and Commitment 2030”, outlining USP’s strategic roadmap and its commitment to strengthening global pharmaceutical quality and public health. The programme highlighted evolving international quality standards and the importance of science-based approaches in ensuring safe and effective medicines.

Mr. Ajey S. Rao, Managing Director of Chromachemie Laboratory Private Limited, spoke on the growth of the pharmaceutical sector and outlined emerging opportunities. The programme saw active participation from students and faculty, who benefited from sessions on impurity identification, quantification, and regulatory reporting.