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Indian pharma works to enable smart laboratory practices to spur transparency & efficiency
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Nandita Vijay, Bengaluru
November 24 , 2022
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Indian pharma is now witnessing smart laboratory evolutions. Digitised technologies are seen to make quality control faster, agile, reliable, compliant, and efficient. This takes centrestage to thwart US FDA observations on data integrity, discrepancies in lab procedures which are the key drivers for digitisation, automation and Smart Data Management Systems.
Noting that quality control laboratories are critical components in drug manufacturing, Kaushik Desai, advisor, India Pharma Machine Manufacturers’ Association (IPMMA) along with Dr Satish Desai, pharma consultant said that digitalised labs connect people, systems and connected devices.
Combined with analytics, the laboratory equipment and consumables can sense, communicate, analyse and act on data optimally. To this end, emerging digital and automation technologies for pharmaceutical laboratories improves planning, control and quality assurance, they added.
The integrated Quality Control Laboratory 4.0 has robotic systems. It enables a modular work environment, and remote access to the intelligent system. Digitised processes eliminate paper printouts. Lots of lab generated data need to be stored, analysed, shared and retrieved. These complex processes call for working on fragmented data systems and validation from diverse sources including regulatory bodies for high standards of data integrity, said Kaushik.
In fact, the Lab 4.0 will not have tables and laboratory benches. The equipment has artificial intelligence capabilities. Product testing is carried out using Process Analytical Technology (PAT), enabling Real-Time Release Testing (RTRT).Innovative features include network enabled devices, automation, robotics, surfaces with weighing and measuring functionality, 3D printers and data enabled goggles which can issue instructions and raise an alert on mobile apps. Lab Execution System (LES) helps the analyst work level minimise human error by ensuring proper execution of all the procedures by the staff. It automates Standard Operating Procedures (SOPs) in a step-by-step manner enabling even newly trained laboratory professionals to consistently and safely carry out routine steps, they noted.
In the lab of the future, systems will communicate to automate the process flows. Cameras will be able to control lab equipment and process sequences. Intelligent modules will switch equipment on and off. To an ever-increasing extent, control of process flows will be based on peer-to-peer communication between lab equipment. The data-centric approach maximises advanced analytics, machine learning and AI-powered predictive technologies to drive proactive and predictive quality management which eventually leads to cost benefit, said Dr Satish.
However, there are challenges in automated technology like for instance data reliability, sensors actuators and integrated instruments operating under adverse physical conditions. Yet there is a need for Indian pharma companies to scale up and put in place a technology plan to address issues of data security. Only this will bring in regulatory compliance and ensure a robust change management with the required skill support, noted Kaushik.
We are seeing that Covid pandemic has seen an extensive uptick in digital transformation by the pharmaceutical industry. From working in n silos, companies have taken on automation to bring in transparency and efficiency in operations, they noted.
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