FEATURE Pharma 4.0y


Meeting the demands of the


pharmaceutical sector Martin Gadsby, Director at Optimal Industrial Automation, looks at how to choose a system integrator that can deliver high-quality Pharma 4.0 automation processes


T


he advent of Pharma 4.0 is driving the creation of interconnected factories that can bring drug manufacturing to


the next level, boosting productivity and end product quality. To succeed in this digital transformation, pharmaceutical companies need regulatory-compliant, fully-integrated automation systems that connect diff erent parts of the plant and monitor all processes. The right system integrator can enhance the reliability, responsiveness and overall performance of the system, supporting manufacturers in the creation of highly-eff ective plants.


Choosing a systems integrator In Industry 4.0, the digital transformation of businesses is a must for organisations that want to thrive in this new, digital era. The ideal digital infrastructure delivers optimum interoperability, to connect diff erent units and share data from multiple sources. It is also fully- integrated, allowing software and hardware components to eff ectively send and receive information. This means that manufacturers must rely on system integrators to build such environments. The fi rst consideration for drug makers looking for system integrators should be sourcing specialists that have good and comprehensive technological knowledge and expertise. With plenty of information technology (IT) and operational technology (OT) solutions available, it is important


possible to deliver optimal solutions. This systematic, holistic and quality- centric approach focuses on building quality into a product – or, in this case, system integration, starting from the earliest planning stages and continuing throughout the diff erent phases of installation, confi guration and programming.


Knowing the sector is key Finally, suitable integrators for pharmaceutical manufacturers should have extensive experience in the pharmaceutical sector and its strict regulations. Searching for integrators that are competent in a specifi c market is crucial, as their portfolio of successful projects can reassure drug makers that their needs and requests are properly addressed.


System integrators should have good and comprehensive technological knowledge and expertise to identify the most suitable solutions for Pharma 4.0


to identify the most suitable to benefi t from highly-eff ective, fully-integrated systems. This also gives manufacturers the confi dence that they are leveraging a single provider able to address any type of project – independently of the scale or complexity.


Suitable system integration providers for pharmaceutical manufacturers should deliver solutions that meet regulatory compliance requirements


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For pharmaceutical businesses Pharmaceutical businesses should identify and favour full-service providers that use advanced quality management systems. Choosing integrators that adhere to renowned standards, such as ISO 9001 (2015), and have a good working experience in good automated manufacturing practice (GAMP), is a must. By working in compliance with internationally-recognised standards and guidelines, system integrators can prove their commitment to quality. On top of that, quality-driven


organisations will also leverage Quality by Design (QbD) approaches where


This also means developing a solution that complies with pharmaceutical good manufacturing practices (GMP). In particular, system integrators supporting this industry should create infrastructures that adhere to standards for data integrity and those for electronic signatures and records (ERES) – such as the US Food and Drug Administration (FDA)’s 21 CFR part 11.


Different offerings System integration providers greatly diff er in their off ering, and it is important to select the right one. The ideal partner should therefore have extensive technology, regulatory and industry knowledge. They should act as a one- stop-shop to provide a fully-integrated and comprehensive system, whilst still adhering to strict quality management strategies. By selecting skilled and quality- driven specialists, such as Optimal, pharmaceutical manufacturers can fully reap the benefi ts of digitally transforming their businesses.


CONTACT:


Optimal Industrial Automation www.optimal-ltd.co.uk


Automation | September 2020 25


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