By: Diti Rastogi, Senior Business Consultant - Life Sciences

The global pharmaceutical industry has traditionally been a complex and difficult space to master. Tasked with serving the health needs of millions of patients with varied afflictions, the industry must constantly meet stringent regulations and compliance standards. One wrong move can set in motion a free falling chain of events. Moreover, manufacturers are constantly working to achieve control and transparency across facilities as rising R&D costs lead to higher drug prices.

Pharmaceutical manufacturing has evolved drastically since the days of the apothecaries and wholesale production in the 19th century. Today, drug makers have mammoth state-of-the-art manufacturing facilities that are driven by robotics, AI and cutting-edge tech-enabled business processes, in alignment with Good Manufacturing Practices (GMP) and U.S. FDA regulations. Recipe processes now go through multiple automated stages as the industry transitions from batch to continuous manufacturing.

Automation is definitively transforming pharma, with regard to product development, commercial production and real-time monitoring. It can foster manufacturing excellence by leveraging sensors and identification systems to not just help companies achieve compliance, but also to do so at the lowest costs. Indeed, many pharma manufacturers have deployed Corrective Action, Preventive Action (CAPA) software to adhere to GMP and FDA norms.

In the digital era, compliance-as-a-service is expensive, but non-compliance is even more so due to the underlying hidden costs. Companies are racing to compete with generics before their product patents expire, so they are turning to automation to boost speed-to-market. Doing so also leads to associated benefits such as product yield improvement, less wastage, greater adherence to safety and environmental controls. All these translate into cost savings for patients.

Quality compliance and cost savings with robotics and AI

Pharma companies are increasingly partnering with external solution vendors to integrate robotics into specific processes concerning drug development, manufacturing and anti-counterfeiting. Operating in an intensely regulated marketplace, drug makers must meet the various guidelines and recommendations outlined for ensuring public health safety. Therefore, they are opting for automated setups and tools that enable effective risk management and greater scalability.

Automation is firmly embedded in primary aspects such as Active Pharma Ingredients (API) and in myriad other secondary aspects including packaging and distribution. As medicines exist in either solid or liquid state, automated manufacturing techniques can master the weighing, blending and tableting of solids, or the stirring and filling of liquids, to deliver global standardization. This new-found precision in laboratory manufacturing is also driving the discovery of new medicines, further boosting the adoption of digital manufacturing.

Another area where automation is having a massive impact is in the supply chain and logistics domain. Thanks to the growing adoption of RFID technologies, electronic batch records and workflow management, medicine delivery has become more effective. Errors and weaknesses in the logistics system can easily be spotted and removed. Thus, the right medicines can now reach the neediest people at the right time, thanks to the help of complex algorithms that can predict the same.

The increased use of robots in pharma manufacturing is also prevalent in processes related to dispensing, kit assembly, sorting and machine tending. These automated processes are teaming up to offer the industry more flexibility, greater speed and lower operating costs. Moving forward, greater integration between development work and manufacturing will be possible. And, it will all work together to reduce the primary cause of error in manufacturing processes–human error.

Bright future for pharma regulatory compliance

Pharma companies are thus looking to integrate the benefits of shared support services and shared environments to reap the benefits of automation now. This can be done firstly by establishing Centers of Excellence (CoE) that enhance each step of the automation process, and by optimizing the usage of data collected through sensors. Doing so can ensure that all the data produced and collected is compliant from a regulatory perspective. This data can increasingly be used for proactive reporting of safety and information management to give pharma companies a holistic approach toward complete enterprise-wide Governance, Risk and Compliance (eGRC).

The FDA is further putting in place guidelines and rules that can pave the way for drug manufacturers to adopt modern technologies that can boost quality. Quality by design and adopting a risk-based approach to automation are just key first steps to help manufacturers head in this direction and deliver the best medicines.