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Nandita Vijayasimha, Bengaluru May 23 , 2025
Indian pharma has noted that to offset hidden inefficiencies in pharmaceutical labs, automation is the way forward. This is because shortfalls in lab infrastructure and processes can slow down innovation, inflate R&D costs, and delay time-to-market for crucial drugs.

According to Chandrachur Datta, partner, Vector Consulting Group, for years pharmaceutical labs have struggled with human errors leading to invalid OOS (Out of Specification) results and lab incidents. Despite extensive training and checklists, the problem persisted, affecting productivity and compliance. There are several hidden inefficiencies in pharma labs and traditional fixes do not work.

Quality control plays a crucial role in the pharmaceutical industry. With human lives at stake, anything that comes into or goes out of pharmaceutical manufacturing must adhere to stringent quality criteria, and any drug must be continuously monitored to assure quality throughout its life, he added.

The majority of these tests are conducted manually. This means every pharma company is dependent on a significant number of analysts to provide tested material at various stages, like for instance raw material, in-process, semi-finished, finished, and stability stage, Datta told Pharmabiz in an email.

Testing includes numerous steps. Each analyst is assigned to one or more tests for the day, which must be completed before the end of the shift. Resources are mostly shared, triggering long queues and the race to capture the ‘right’ resources. Some uncertainties make resources unavailable even during the shift. Complexity gets aggravated when there is a lack of clarity in the given testing protocol, or the method requires elaborate steps, he said.

To make up for the loss of time, analysts try to complete the remainder of the work either in a rush or by multitasking which could lead to miss even the simplest things before one's eyes. Such errors are committed by both experienced and newcomers.

When a lab starts experiencing multiple such events (OOS/OOT/Lab Incidents), the load on the investigation team to do a thorough investigation within a strict timeline increases significantly, Datta pointed out.

In such a rush, most investigations end up addressing just the symptoms with surface-level interventions like Corrective Action and Preventive Action (CAPA) with training, warnings, more checklists, etc. They either add more activities to already-loaded analysts or allocate more resources for prevention. Such short-term fixes do not last long, and soon, errors resurface, he pointed out.

Therefore, it is critical to ensure that the analyst is not distracted by critical steps. This is achieved by creating work centres, which help improve an analyst's focus and unlock significant analyst productivity in pharma. Following a set implementation sequence, the lab starts experiencing a significant reduction in the rate of error generation and the number of investigations that are open at any given time. The entire lab ecosystem, spanning analysts, investigation team, planners, section heads, and all senior management, benefits from this, said Datta adding that the Vector Consulting Group chips in expertise to identify and eliminate systemic issues and implement a sustainable solutions to offset hidden inefficiencies in the pharma labs.

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