Edition 4 / May 2019
Dr. Macniell Esua
Chief Compliance Officer,
Since coming on board as CordenPharma’s Chief Compliance Officer three years ago, I have worked together with the Leadership Team to continuously improve and harmonize our quality operations by forming the CordenPharma Global Compliance Team.
Our commitment to seek the highest standards of “Quality & Compliance First” is the backbone of all our activities and projects. We make no compromises in this area, having invested around 2.9 Million Euros in compliance programs over the last three years, with the objective to meet and surpass applicable regulatory requirements and legislations. From 2019 – 2021 we have budgeted an additional ~1 Million Euros for implementing compliance enhancing IT-solutions.
Your project will benefit from the ongoing support of CordenPharma’s continuous improvement program, which is based on the consistent completion of corrective and preventive actions arising from self-initiated proactive third party group-wide gap assessments, agency inspections, as well as internal, annual corporate & customer audits. This approach enables us to not only meet, but surpass general requirements needed to see your project through to completion.
The CordenPharma Global Compliance Team systematically interprets these continuous improvement program audit and assessment results on your behalf to generate corporate policies and global standards which enable employees at all levels to comply with current applicable guidelines and legislations in their daily activities.
Corporate compliance standards & policies are then implemented at all CordenPharma sites globally, with the objective of complete harmonization to foster transparency and straightforward communication, both internally and externally with our customers. The whole organization works together, from the Leadership Team and Facility Managing Directors to the Marketing & Sales team and operators, to make sure all employees effectively comply with implemented policies, Standard Operating Procedures (SOPs), master work instructions, plans, forms etc.
In 2018 CordenPharma passed 5 US-FDA inspections, 3 of which received no form 483 observations issued, and 2 of which received “Voluntary Actions Indicated”. Although we still have more work to do to bring all CordenPharma facilities to the same level, these inspection results reflect significant improvement in regards to quality & compliance. Our rapid harmonization over the last three years leaves me personally convinced that our approach will be sound and effective in bringing all sites to the same level, sustaining our achievements, staying on the path of continuous improvement, and implementing further changes to regulations and legislation as they happen.
We further support your projects by looking beyond the confines of our company to participate in industry meetings and strengthen communication with global and local agencies in order to proactively work on our compliance and quality programs. Patient, Health & Environmental Safety are at the center of all our quality and compliance endeavors. We strive for the highest standards for our employees, our sites, our customers, and ultimately, for patients.
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