Implementation of an Independent QMS, CE Certification and Post Market Surveillance at Galderma SA
My first key objective at Galderma SA back in 2009 was to implement a Quality Management System (QMS) and gain certification to the ISO13485:2003 standard. In parallel we also needed to obtain the CE certification for Class III Medical Devices (injectable solutions for wrinkle filling) via the Own Brand Labelling procedures. Galderma SA was predominantly a dermatology company, venturing into the corrective and aesthetic field and my task was to ensure all the relevant systems and processes were in place and sufficiently certified to market Class III Medical Device fillers.
The strategy developed was to create a standalone Quality Management System separated out from the rest of the global organisation in order to minimize disruption to the GMP Pharmaceutical processes and procedures and to achieve certification in the most efficient way possible. The legal entity chosen was the headquarters in Switzerland, Lausanne, a separate company was not set up but the boundaries with which the QMS was created restricted any exposure to unrelated processes within the global organisation.
Essentially the QMS implemented, was something similar to a small start-up, an independent business management system, allowing the medical device organisation within the global corporation to operate autonomously. The CE certification at the time was via the Own Brand Labelling (OBL) procedures, thus I had a close collaboration with the key sub-contractor for both the manufacturing and Technical File creation. For this particular product one of the biggest challenges was to ensure appropriate level of manufacturing (GMP standard) standards in order to confidently place the product on the market. This was a sterile medical device being injected into patients and thus the level of control applied was parallel sterile drug products.
Certification to the ISO13485 and CE Marking via the OBL was received by mid 2010 and we were on the Market by the end of 2010. The whole process took us around 18 months, achieved via fantastic teamwork, a solid strategy and a common sense approach to achieve our goals.
The post market surveillance process was also set up as part of the QMS implementation, it was not just a copy and paste from the Pharma processes already in place at Galderma SA, in fact the requirements are not quite the same and thus we created a process for the medical devices. The key difference being that all ‘Complaints’ received for Medical Devices must be assessed for reportability to the health authorities, as well as assessing whether a malfunction could have potentially led to a serious incident, which may lead to reporting.
All this meant a close collaboration with the Safety group and implementing an efficient system that was realistic for the size and volume of the medical devices organisation within Galderma SA. The key steps implemented were that all cases both medical and technical were privy to the Quality and Vigilance groups, each case was assessed for reportability and when there was an incident deemed not reportable a qualified physician would provide the justification. This process set up worked extremely well without a complex change in existing processes and procedures.
I spent approximately 4.5 highly productive and successful years at Galderma SA and was able to see through the entire process from implementation of a QMS to post market surveillance monitoring.