I have not heard of any recall yet related to a CM process, deviations and recalls are a lot less likely for a CM process, as quality is built into the CM process and the measuring resolution is a lot higher - so any out of specification material will be identified/predicted and rejected up front.
In case a deviation or even recall would ever happen, the problem identification, isolation and resolution will be a lot easier:
- the final material is fully traceable to it's excipient and API lots thanks to RTD and process models
- the amount of data generated during development is a lot higher: design spaces, operational boundaries, impact of material variation and equipment configuration is very well understood
- Tech transfer is mostly done to similar or identical equipment, which links commercial data with more certainty to development data
- During commercial manufacturing also a lot more data is being generated so the root cause can more easily be identified and proven
- Because of the data rich commercial process, the effectiveness of a CAPA will also be easier to demonstrate
I have not heard of any recall yet related to a CM process, deviations and recalls are a lot less likely for a CM process, as quality is built into the CM process and the measuring resolution is a lot higher - so any out of specification material will be identified/predicted and rejected up front.
In case a deviation or even recall would ever happen, the problem identification, isolation and resolution will be a lot easier:
- the final material is fully traceable to it's excipient and API lots thanks to RTD and process models
- the amount of data generated during development is a lot higher: design spaces, operational boundaries, impact of material variation and equipment configuration is very well understood
- Tech transfer is mostly done to similar or identical equipment, which links commercial data with more certainty to development data
- During commercial manufacturing also a lot more data is being generated so the root cause can more easily be identified and proven
- Because of the data rich commercial process, the effectiveness of a CAPA will also be easier to demonstrate
