The countdown which started several years ago has now reversed.
It has been 4 months since the implementation of the FMD Directive 2011/62/EU.
Chemineau Labs were ready on February 9, 2019. Committed we were, committed we are, at least at our level…
Far beyond the technological challenge, the impact on our organization, our tasks, our tools, our processes, our flows have largely been analyzed and anticipated by our cross-functional teams throughout the major phases of the project.
Largely, we are convinced of this, even if the need for the first assessments is necessary. This sharp and objective screening is the warranty of the work carried out tirelessly on our overall performance, subject to the continuous pace of markets and the requirements of customers.
Take the new quality constraints. They impact, for example, the auto-controls management performed on finished products. New defects and criticalities have been defined between production and quality, and operators are now implementing them with ease thanks to their experience and know-how. The extra time spent processing these new features is real and requires fast adjustments by operational teams.
Batch files include new raw data, the review of which ensures compliance with GMP and the Directive. The flows inevitably lengthen.
The industrial impact is certain. The OFs are under stress and the losses of production adhesion very real: frequent level 3 computer bugs much more impactful than those of level 4, assimilation of mechanical adjustments and computer interventions much more complex than expected, painful learning curve… The presence of a TMA (Third-Party Application Maintenance), implemented from the start of the project, proves to be a valuable help.
So impacts? Yes, many! We have had many and will have others tomorrow. But Chemineau Labs are confident and continue to build step by step this strategic project.
And now? Our teams are fully operational and are already setting up new projects with serialization…