How Is Technology Disrupting The Pharma And Life Sciences Industry In 2019

By Onkar Kapoor, Group CIO & Head IT, Akums Drugs & Pharmaceuticals Ltd.

Onkar Kapoor, Group CIO & Head IT, Akums Drugs & Pharmaceuticals Ltd.Every Pharmaceutical & Life Science Company has the top most obligation and business need of best quality products which are safe & regulatory compliant. The biggest challenge to achieve that is how to avoid human errors (most of the time unintentionally). Any mistake at the time of drugs production may impact on many innocent peoples’ / patients’ life. Here technology plays a major role. Computer systems, robots, machines work with much less errors / mistakes and always follow the predefined rules / instructions. The centrally controlled computer systems always have the accurate date & time stamp. For the process(es), computer systems will either follow the process(es) 100% or will start giving errors but will never bypass the process or will never follow the wrong process.

Pharma and Life Sciences – Concerns

Although all the pharmaceutical companies keep the users’ health and safety on their top most priority, even then their product(s) has to undergo certain processes before it can be used by public. These processes ensure that the product is safe for everyone and if there are any side-effects for that particular product, the consumer can be warned about that well in advance. Before a pharmaceutical product can be used, the company has to present the evidence of efficiency and safety. For this they have to run trial, studies and lab testing. This process is very important for the patients’ safety so the regulatory companies are very strict on the processes and to assure the quality and safety their audit processes are even more stringent.

“The year 2019 is the year with new concepts and technologies. Technology is mature now and can demonstrate business values”

If we talk about regulatory agencies, there are many and US FDA guidelines and GxP best practices comes on top. There are certain guidelines (most popular and adopted GAMP 5) to help the pharmaceutical companies to produce the safe & quality products. There are guidelines for all the stages from raw materials to the finished products. There are guidelines to keep the records of manufactured products to pass the audit processes. To avoid any human errors, any quality and safety concerns, the documentations also needs to be compliant.

For the documentation and to avoid any human or integrity related concerns, regulatory companies introduced the concept of ALCOA.

Although ALCOA provides the guidelines but for the best control, computer systems based documentations, real time logs, non-editable system logs / audit trails provide the best controls.

(To assure the computer systems are working accurately, there are again certain guidelines and complete computer system validation processes.)

Although the pharma and life science business is profit making business but carries lots of responsibilities and high risks. It is business need to assure manufacturing accordingly & pass the process(es) (provided by regulatory agencies) before sending the product out in any specific market. Any failure in passing the process / guidelines, may impact on huge business losses, damage the brand image or a business failure too. For patients’ safety and to match the regulatory and business needs, the best solution is technology and automation.

The year 2019 is the year with new concepts and technologies. Technology is mature now and can demonstrate business values. Now the pharma & life sciences industry has started adoption and implementation of Industry 4.0 with IoT, Industrial IoT, BOTs, OEE, CDAS, MES, AI, ERP integrated LIMS, paperless Labs, eBMR, BIMS, eQMS, Grid computing (for new molecules discovery), electronic submission of first-to-file, track & trace, barcodes / QR codes based tracking of products, robotic process automation and many more technology solutions.

The best part is, now different technologies have started working together in tightly integrated manner to provide the overall solution to business. PLC / HMI / SCADA and HPLC systems now work with computer systems and provide central logs and controls. IoT and industrial IoT has further enhanced the level of controls, e-log and reports for the better quality & productivity.

The eQMS (electronic Quality Management System) with integration of employee’s recruitment, performance appraisals and LMS (Learning Management System) not only helps to manage ‘change controls’ and ‘CAPA (Corrective and Preventive Actions)’ but also helps to identify the employees / shop floor staffs training needs, helps to provide them required trainings with proper training records.

The integrated ERP and LIMS system helps to control the quality of the products from raw materials to the finished products.

The track & trace systems help in supply chain management and complete tracking of products. Even the recall of any product (which becomes the Pharma & Life Sciences Business need some time) is now easy to manage.

Where Industry 4.0 deployment is in high pace, the industry 5.0 is already in discussion and intelligent robotic solutions are already available in market. Industry 5.0 will return focus to the human aspect of manufacturing whereas Industry 4.0 focussed solely on the technology.

With this focus returning to humans, the 5th industrial revolution may also require a new manufacturing role: Chief Robotics Officer (CRO), an expert who specializes in human-machine connectivity and will be responsible for all aspects for making decisions on which machines or devices to add to the plant floor for improving strategies for optimizing the production line(s).

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