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It is with utmost pride that Microbioz India annou
Mumbai, June 05, 2025
For some time now,
In our cover story, we shine a spotlight on “ The Magazine
Like almost everything else, the COVID-19 worldwide health emergency changed the competitive dynamics of the pharmaceutical industry in regard to the speed at which lifesaving drugs are developed and brought to market. Now, companies need to balance moving faster than competitors while still being able to meet quality control (QC) thresholds.
As the pharmaceutical industry moves towards developing complex biologics and precision medicine, the demand for quality-control processes that are both efficient and fast is rising.
Drug research and clinical trials tend to be very agile these days, particularly in comparison to QC verification processes. In most cases, QC involves manual testing processes and data silos which leads to a large loss of time. With this inefficiency comes a loss in regulatory compliance trust as well, leading to a reputation for tardiness. Each of these deficiencies combined results in constricted QC processes that take longer and longer to execute.
“Speed is no longer a luxury—it’s the norm,” Asha Mehra, a renowned pharmaceutical scientist, remarked.
“But modern QC systems have to be in place, otherwise modern speed could be a safety risk. That’s a sacrifice we can’t afford.”
Emergence: QC that is data-driven, digitized, and decentralized
What we can foresee now is real time, risk-based QC, more proactive than reactive.
PAT enables quality-critical attributes to be evaluated while production is active, delivering right first time execution, in contrast to traditional methods which require waiting until a batch is complete.
Many QC laboratories have implemented algorithms that monitor compliance and anticipate variations proactively, eliminating traditional reactive models that rely on triggering events.
In high throughput laboratories, human sampling is being replaced by robotic arms equipped with sensors, resulting in greater reproducibility and decreased contamination risk.
Laboratory Information Management Systems (LIMS) now interface with the entire organization, eliminating delays in traceability or audit preparation and enabling collaborative work from any location.
With an increasing number of companies transitioning from batch processes to continuous workflows, QC must evolve to include in-line testing and real-time release protocols.
Compliance From Guidelines To Real-Time Compliance Regulatory bodies like the FDA, EMA, and CDSCO not only accept these changes and transformations but also intend to drive them forward.
They have placed emphasis on the adoption of modern QC tools as well as the adoption of a digital quality systems. Numerous guidances also advocate for QbD (Quality by Design), RTRT (Real Time Release Testing), and best practices for data integrity.
Even in India, there is some movement in the country’s pharmaceutical regulatory landscape. The CDSCO has been advocating for transparency in compliance and the use of remote audits, which indicates movement towards a globally unified QC framework.
As test automation increases along with artificial intelligence, QC staff are now shifting into more advanced roles such as knowledge workers that include system management and analysis of complex data sets as well as the digital systems themselves, controlling and prompting ongoing process improvement programs.
Prashant Kulkarni, Head of Digital Quality in one of the big pharma companies, states: “Tomorrow’s QC analyst is a hybrid,” They will require self-sufficient capability, technological literacy, regulatory comprehension, and most importantly, strong analytic capabilities. No longer merely ticking checkboxes, but exercising executive functions on quality leadership.”
In the context of accelerated pharma, QC is transforming from a requisite for compliance to a strategic innovation. Companies adopting next generation QC technologies are the ones leading the market, building trust, lowering recalls, and creating sustainable operations.
As we reassess QC under financial constraints, one fact stands out: Precision, in this case, is not a restraint; it is a forward thrust.
