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Dear Readers, Welcome to the latest issue of Micr
India’s pharmaceuticals industry is a major player in the global pharmaceuticals market. India is ranked third in the world for production volume and 14th for value. India is the world’s largest supplier of generic medicines, with a share of 20% in global supply. It is also the top vaccine manufacturer worldwide. India is also home to the largest number of USFDA compliant Pharma plants. It has more than 3,000 pharmaceutical companies and a strong network with over 10,500 manufacturing facilities.
Some are calling innovative or collaborative partnerships in pharmaceuticals the “new norm.” However, authentic, independent or open source collaborations remain a rare feature of the life-sciences industry. There are many companies that have established in-house innovation labs. They believe these models are crucial to faster bringing new treatments to market. Collaborations can lead to novel treatments that no one company could create on its own.
The new technologies which characterize Industry–from connectivity and advanced analytics to robotics, automation–have potential to transform every aspect of pharma-manufacturing laboratories within the next five to 10 years. In real life, the first use cases have shown a 30-40% increase in productivity in labs that are already efficient and mature. A full range of improvements could result in a reduction of over 50 percent in quality-control costs. Automation and digitization will ensure higher quality and compliance, while reducing variability and manual errors. It will also allow for faster and more effective resolutions of problems.
Representative Picture
Although most of the latest technologies are available today, very few pharmaceutical companies have yet to see any real benefits. Quality leaders are often unable to articulate a business case for technological changes. This makes it difficult to convince senior management that lab automation or digitization can have significant impact. Companies rarely have a long-term strategy or blueprint for lab evolution. This can lead to costly investments that do not yield clear benefits. Many companies have taken steps to go paperless, such as simplifying paper records and digitizing laboratory testing records. These efforts are now being replaced by equipment connectivity, which allows direct transcription of thousands upon thousands of data points without the need for manual data transcription or reviews.
Data is essential for pharmaceutical laboratories. There are many data files that need to be stored, analyzed and shared. Data is vital for delivering the desired outcomes to insurance companies, governments and pharmaceutical companies. These laboratories also have to deal with complex laboratory processes. This includes fragmented data systems, validation of data from multiple sources, and regulatory requirements for data integrity. These are great opportunities for pharmaceutical labs to digitize their entire laboratory workflow to reduce costs, improve efficiency, and provide accurate and timely information.
Digital laboratory environments are able to give meaning and purpose to data. This allows for “digital moments”, where decisions can be made at the intersection of people, business systems, and connected devices. A digital laboratory, which includes analytics, laboratory equipment, consolidated platforms and consumables can communicate, analyze, and act on data in a highly efficient manner.
Smart Informatics systems can uncover new findings, highlight hidden information, and reveal new insights that were previously unanticipated or impossible.
Digital quality control/quality assurance (QA/QC), systems increase our confidence in data, interfaces and methods leading to a decrease in errors, product quality improvement, enhanced Electronic Batch Record (EBR), and improved compliance and regulatory adherence.
Many valuable research data are not protected by patents or are held by subcontractor clinical research organisations. This raises questions about third-party security and assurance.
Digital Laboratory Information Management Systems, (LIMS), help to accelerate laboratory test milestones.
Laboratories 4.0 (modeled on Industry 4.0) allows for more efficient data exchange and use of laboratory resources.
