The rules of patient care are constantly changing as the regulatory authorities scrutinize every detail of drug development. This puts pharmaceutical companies under immense pressure to stay on their heels all the time to track the regulatory changes and implement them. However, relying on legacy tools to monitor and improve the manufacturing and supply chain process can prove counter-productive and may even lead to non-compliance issues. To keep up the pace with evolving regulatory landscape, The International Society for Pharmaceutical Engineering (ISPE) has long advised embracing Pharma 4.0 which was further supported by the ICH. Delve further to learn how Pharma 4.0 can augment the manufacturing and supply chain for companies and how SAP S/4HANA can contribute to enabling it.
What is Pharma 4.0?
A subset of Industry 4.0 or the fourth industrial revolution, Pharma 4.0 is specific to the pharmaceutical industry, and it is still evolving. It utilizes the power to connect equipment, devices, and systems by digitalizing the operations to continuously monitor them and record the relevant data. The result is a smart factory with a connected workforce that can communicate continuously offering transparent visibility and traceability all of which offer granularity in data accumulated that can be used to make predictive assistance for plant maintenance, streamline material supply & distribution, and above all reinforces informed decision making.
Challenges for the industry
Efforts to modernize the pharma industry are often disrupted due to the effects of siloes, non-utilization of data, fragmented manufacturing process, and lack of diversification of product portfolio (i.e., blockbuster drugs focused on volume). The advent of Pharma 4.0 can prove beneficial to overcome these challenges, but a pharma manufacturing plant must also abide by Good Manufacturing Practices (GMP) and comply with the regulations of local regulatory bodies. So, the solution must improve not just the manufacturing operations but support quality control efforts, enable the workforce, and monitor all of that in real-time to share relevant inputs that can assist with the development of personalized treatments opening up the possibility of new revenue streams.
SAP S/4HANA for Pharma Manufacturing
SAP solutions for the pharma industry focus on end-to-end operations allowing stakeholders to bring down the siloes to form a connected ecosystem. A well-connected ecosystem allows stakeholders to understand and analyze the effect individual processes have on each other and the overall plant efficiency as well as the product quality. Digital transformation of pharmaceutical companies also allows establishing predictive maintenance procedures as opposed to reactive maintenance which can reduce downtime.
The real-time monitoring powered by SAP best practices for pharmaceuticals will reinforce better quality control measures to ensure formulation remains consistent and pure throughout its lifecycle. A digital environment also makes the risk assessment simpler and more seamless for the documentation. SAP solutions allow you to track the supply chain and understand patterns in demand to alter the production volume and reallocate resources judiciously.
With numerous modules that can support end-to-end operations held together by a digital core of SAP S/4HANA, pharma manufacturers can simplify GMP compliance efforts, effectively foresee uncertainty, and improve overall efficiency and product safety which is crucial for every drug product.