Don’t think that your CDMO will be better than your own plant!
For various reasons, saturation or aging of your equipment, back-up manufacturing of your key products, you have chosen a CDMO (read the post 10 key points to choose your CDMO). It is a relationship of trusting partner that you will build and that will evolve timewise … a bit like love!
First we are charmed, then comes the time of partnership contracts, finally, we discover that the ideal being has the same flaws as the others … and finally we live with compromises (or not, by the way, but far from me the idea to comment on the sentimental life of the French people… hum stay on the subject)!
Sales people will tell you what you want to hear during the discovery phase, a CDMO, even expert in a galenic form, remains a factory, with its organization, its suppliers, and all the hazards that may occur. Like on your plant. A supplier who serves you badly, will badly supply your CDMO, a non-robust file at home (subject to unpredictable manufacturing leading to non-conformities) will not be more robust at your CDMO!
This is why transparency is extremely important between two partners. It is necessary to establish clear rules in the contracts and to share the history through the study of the files, sharing experience between the expert technicians around pilot batches … in order not to end up in insoluble situations by the after.
I recently had an example of a customer who asked us for a price that did not include the risk of non-compliant lots, because “we are experts, and we have to produce compliant”! Certainly, but by studying the history and exchanging with the technicians in charge of the production of this specialty on its plant, we discovered that one batch out of three led to a derogation … how would that be with a CDMO?
And yes, contrary to conventional wisdom about couples, the routine does not make the relationship with his CDMO monotonous, but reassures … In order to find a compromise with this client, we proposed to carry out a precise and routine follow-up of the first batches manufactured at us to validate together the robustness of the Dossier … and our expertise has allowed us to detect issues and improve the process, at home, but also in its factory, which now allows, after a variation of type I, not to derogate anymore to release a batch out of three.
So, don’t think that your CDMO will be better than your factory, it will have other qualities, and also other issues, the important thing is to progress together, same as in life!