Reduces costs, addresses data integrity-related issues, improves productivity, compliance, ET HealthWorld

Hyderabad: ETPharma recently organised the inaugural Next-Gen LabCon Conference themed ‘Building and Benchmarking Robust Pharma Labs Operations: Today and Beyond’. The event brought together industry representatives and drug regulators to discuss the effective implementation of LIMS and other digital solutions. The topics covered were: drug discovery, pharmaceutical manufacturing, data management challenges, laboratory equipment, consumables, workflows, and data analysis.

The event witnessed a fireside chat on ‘Embracing Change: Exploring Digital Transformation in Laboratory Informatics’. The participants for the chat were Dr Damodharan M, Chief Quality Officer, Global Quality & Regulatory Affairs, Sai Life Sciences Limited, and Dr Sujay Rajhans, President, R&D, JB Pharma, moderated by Vikas Dandekar, Editor, Pharma & Healthcare, ETPrime.

The chat began with how digital transformation is phenomenal, Dr Damodharan shared, “In 2014, when we started our digital transformation journey, we were very primitive in the digital thought process. We went digital due to the CSV guidelines for twenty years, which neither the industry nor the regulatory understood. After twenty years, a good auditor came and helped us understand through warning letters. I have been fortunate to face such auditors.”

He further added, “When I started working at Sai, we aimed to avoid data integrity. One of the tools was converting from manual to digital to get away with data integrity breaches or that is what we thought. We didn’t understand digitisation, digitalisation and now the digital transformation.”

“When we started in 2014, we mapped our processes of what we were doing manually and converted them into electronic processes. In R&D we developed an electronic notebook internally. In manufacturing we implemented material management right from the vendor qualification onwards; material in, sample management, analysis, testing, and approval, in quality we have implemented deviations and outer specifications. Similarly in document management systems (DMS systems), specifications, HCPs, protocols, and SOPs have been mapped. We mapped the processes from 2014-2017. To develop these we need to have a good partner, fortunately, we had a partner locally available,” continued Dr Damodharan. He further added how standard software developers take substantial time in developing configurations and there are costs involved. For Sai Life Sciences they got a good developer that was available locally. The journey of implementing digitisation started in 2017. When the process mapping was done to digitise the process the training of people, adoption of the culture and bringing in the cultural changes was the challenge.

“We automated our production blocks in the APIs production; our quality control is now completely paperless with our LIMS integrated with our system, which we have developed. This is the journey we started, adding more management systems. Currently, from digitisation, we have gone into the next system of data analytics. Unfortunately, due to COVID, our processes were slowed,” remarked Dr Damodharan.

Commenting on the benefits of digitalisation, he added, “To take the benefit out of digitalisation trending of impurities, deviation, or invalidation. From LIMS, the invalidation was happening due to the people, the method, or planning. There has been a dashboard created that has given us the benefit of analysing everything. Initially, we were doing it manually where comprehensive reports were generated, and now it can be done in the system itself.”

“The second benefit is how long the equipment is used for a process, cleaning, and regulatory compliance. Digital transformation has helped remove compliance risk, during COVID, a lot of virtual audits took place.” Dr Damodharan continued, “The CDMO business is growing well in India, so this is a business gain and a gain in confidence, and data analytics help increase productivity.”

Speaking about disasters in the pharma industry, Dr Rajhans said, “The Indian industry is known for its right-time supply, the goods are supplied at the right time and in volume across the globe. This is happening because of manufacturing productivity, and more focus has been on manufacturing and upgrading manufacturing equipment for a long time. India’s story started with low-cost manufacturing. In low-cost manufacturing, productivity takes the first seat, and somehow, in this journey, compliance took a back seat.”

He added, “The dark side of the Indian pharma industry is compliance and data integrity issues. They are sporadic, but they are spread across small to larger organisations. The two reasons responsible for this are human errors and communication gaps. Ironically, India is driving the IT sector; we are not leveraging the Indian IT sector for pharmaceuticals or our business.”

Dr Rajhans added that human errors and communication gaps can be eradicated with the help of digitalisation because most of the failures are due to the lack of communication and communication happens where efforts are put in. Communication can be built using IT.

Currently, QA is being done by humans, which will be replaced by IT in a few years. The industry is moving in the direction of review by exception and reviewing everything.

“One of the reasons that the pharma industry has not benefited from IT is due to the focus on productivity. Indian manufacturers have very high-end machines, which are appreciable, but looking at other laboratory informatics, there is still a lot of integration required as these software have different platforms and don’t interact with other software. Secondly, we are generating too much data even when artificial intelligence is deployed, as it has its limitations unless the data is used contextually; otherwise, it will lead to bad decisions and bad information coming out of it,” stated Dr Rajhans.

According to global forecasts, the Indian pharma industry will adopt digital transformation and grow to $130 billion by 2030. The next decade will see the transformation of quality through IT.

Commenting on the impact of digitalisation on small manufacturers, Dr Rajhans added, Earlier, digitalisation was considered a burden, but as adoption increases, it will come as a flow, and everyone will have to flow with that, so much so that organisations will understand the return on investment (RoI) within a year or two.”

Adding to it, Dr Damodharan said, “Small manufacturers can start small as they don’t have the kind of money that big manufacturers have, such as material management, and see the benefits of it. A lot of new players are coming in, and small manufacturers can start working with them and then expand. It is going to help smaller organisations reduce costs and increase productivity. Digitalisation is going to be beneficial not only for the big players but also for the small players, as it will generate huge amounts of data that will help reduce CAPEX, efficiently analyse processes through deviation dashboards, and failure dashboards, and narrow down the root cause to avoid failures. It will benefit regulatory inspection and confidence in the organisation and the customer.”

Dr Rajhans mentioned, “The most important benefit is the redundancy reduction, as manufacturing capability is at the mercy of humans, so there is a lot of redundancy in the system. With integration, things become efficient, and there is a reduction in batch failures and the cost of batch failures.”

In conclusion on disaster alerts, Dr Rajhans and Dr Damodharan shared that the benefit of digitalisation is that it gives real-time alerts for any probable failure in the future. The next decade will be pattern- and trend-dependent, and leading indicators for failure can be extracted to alert the organisation to take action.

  • Published On Aug 30, 2023 at 12:57 PM IST

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