SMEs trying to get their companies ready for digitalization, quickly find themselves faced with major tasks. These challenges can be particularly daunting for companies in the highly regulated pharmaceutical sector, who together with their contractors, require a large volume of diverse documentation and data integrity to insure cGMP compliance. The SME ChemCon, situated in Freiburg, has decided to embrace this challange and thereby invest in growth and competitive capability. 2018 will see the contract producer of APIs' stepwise implementation of the digitalization of their operations.
Siemens AG will be guiding ChemCon along this complicated path to full digitalization. With the new concept 'Digitalization Consulting', they have already been smoothing the way for ChemCon since 2017. Siemens offer an attractive and integrated approach, rather than relying on a collection of isolated solutions.
An important milestone is the digital harmonization of analytics and Quality Control. Recently ChemCon stared offering Analytical Services independently from contract production. With almost twenty years of experience in method development and validation, documentation, and release according to cGMP, ChemCon is an exceptional partner for complicated analytical undertakings. ChemCon's analytical expertise is further supported by a diverse array of equipment, including NMR and ICP-MS/OES.
Dr. Raphael Vogler, CEO, discusses the special challenges faced by small and medium-sized pharmaceutical manufactures and his collaboration with Siemens on the path to digitalization.
Dr. Vogler, ChemCon is a fast-growing enterprise in the pharmaceutical industry. What are your key features?
Dr. Raphael Vogler: ChemCon fills the niche of producing specialty chemicals and drug substances in small quantities. Many pharmaceutical and biotechnology companies seek manufacturing partners for substances with an annual demand of less than a few hundred kilograms. The production of such small quantities is often too expensive to be profitable. With an innovative production concept, we turned this challenging tast into a succesful contract manufacturing service. In addition, we recently began offering comprehensive, in-house chemical analytical services independently from production. We are also very proud that critically ill patients worldwide now benefit from the substances manufactured here at ChemCon.
What are ChemCon's primary challenges in times of digitalization?
Vogler: The production of active pharmaceutical ingredients is strictly regulated to ensure consistent documentation and data integrity. Existing digital solutions compliant with US-FDA (Food and Drug Administration) regulations used to be very challenging for our small-volume, hands-on projects. Instead, we chose to use paper-based cGMP* documentation. But we often joke that one kilogram of product ist delivered with ten kilograms of paper, which often wasn't even an exaggeration. Today we have reached a size where digitalized processes will bring a huge advantage to grow and to compete in the global market. For an SME like ChemCon, with about 100 members of staff, the step away from paper towards fully integrated digital solutions is enormous, both in terms of work expenditure and financial resources. However, industrial standards have since been developed to help pharmaceutical companies on their path to digitalization. And this is where the Siemens digitalization consulting project came in.
You chose Siemens as a Consulting Partner to start your Road to Digitalization. Why Siemens?
Vogler: Siemens is known for its extensive experience and domain expertise in optimizing pharmaceutical processes. Actually, several different aspects convinced us. Initially, we contacted Siemens for a number of individual technical solutions, including a labor information and management system, to manage our Analytical Services. It was Siemens' initiative to offer us a comprehensive digital consulting approach rather than isolated solutions. A very deep analysis of our internal processes ensured that the proposed solutions could be perfectly adjusted to our requirements and capabilities. We also benefited from Siemens' exemplary support through its regional sales organization in Freiburg. They immediately understood the challenges we face as an SME and kept them in mind at all times.
Did any aspect of the collaboration with Siemens strike you as particularly inspiring?
Vogler: We were positively surprised by the extremely neutral and customer orientated approach of the Siemens consultants. One might expect that consultants from such a large corporate organization might promote their own products and technical solutions. This was certainly not the case. On the contrary: The methodology and the quick comprehension of the challanges of digitalizing a cGMP-regulated organization strucks us as extremely helpful. Proposed technical solutions were always well researched and took into account different suppliers. ChemCon is extremely quality driven. Siemens understood this necessity and met our high-quality demands with an equally high-quality, tailor-made service.
What are the most important milestones for yourself and your team in the implementation of the digital roadmap?
Vogler: Siemens' digital roadmap provides us with a clear schedule how to improve our processes through validated digital systems while maintaining full data integrity. This is an extremely important step for us to continue to grow in an increasingly digitized industrial environment. And our customers can continue to rely on ChemCon as a reliable partner with high-quality products. With the digital roadmap, Siemens has started a long-term project for ChemCon. Although the project management will now be centered at ChemCon, we will certainly continue our collaboration with Siemens. We are convinced that in the future milestone meetings will be crucial in helping ChemCon to succeed in its stated goal of significantly increased productivity through digitalization.
*cGMP (current Good Manufacturing Practice):
An aspect of quality assurance, which guarantees that products are uniformly produced and tested according to quality standards that meet the product's intended use and are in compliance with the approval documentation. Good manufacturing practice applies to both production and quality control.
Source: Translated from www.was-ist-gmp.de/gmp/was-ist-gmp/
