Secure your pharma QC results by secondary standards

At the Ahmedabad Pharma Summit 2025, Dr Shankar Varaganti, Commercial Marketing Manager, Merck, delivered a presentation on advancing pharma quality control (QC) through robust reference material solutions. His session, titled ‘Secure Your Pharma QC,’ began by outlining the complexities of pharma drug development. He stressed that accurate analytical testing is a vital pillar of this process. He highlighted key challenges in pharma QC analysis, including the detection of impurities, extractables, leachables, nitrosamines, heavy metals, and residual solvents.

He explained the essential role of reference standards in every stage of the analytical workflow, from sample collection to quantification and reporting. Drawing attention to the resource investment required for companies to develop in-house working standards, he presented Merck’s Pharma Secondary Certified Reference Materials (CRMs) as an efficient and globally recognised alternative. He informed that these CRMs offer full traceability, regulatory compliance, and consistent performance, reducing the burden on pharma companies.

A significant focus of his session was the concept of metrological traceability, emphasising the importance of standards that are linked to internationally accepted measurements, such as those maintained by National Metrology Institutes (NMIs) and pharmacopeial bodies like USP and EP. Dr Varaganti explained the traceability pyramid, which ensures the highest levels of accuracy and confidence in QC results.

He also elaborated on Merck’s innovative approach of providing dual traceability — linking both to pharmacopeial primary standards and SI units via mass balance or quantitative NMR methods. This dual validation gives companies a powerful assurance of quality and compliance during audits and regulatory reviews.

Additionally, Dr Varaganti showcased Merck’s expanding portfolio of over 3,000 secondary pharma standards, covering a wide range of APIs and related compounds.

In conclusion, he highlighted that Merck’s Pharma Secondary Standards not only save time and resources but also help pharma companies achieve excellence in their QC practices, paving the way for safer, more effective medicines.