Is it necessary to verify/validate basic IPC methods such as disintegration and friability? Are there any regulatory guidelines?
You should be using USP methods! Who is IPC??
USP methods do not have to ‘validated’, but they have to be ‘verified’ to be acceptable in your hands for your sample.
IPC - In Process Control?
Aren’t these also release methods as well? I would expect disintegration and friability to be release criteria as well.
I’m not sure about this. Are the IPC methods only helpful to tune a machine, while finished product methods are required to release a product to market? The argument could be made that release methods will be done, and are GMP, and this is the quality “gate”. So there is no risk of a product every leaving the plant that doesn’t meet disintegration/friability results.
I think that defense may have been more accepted previously. I think in the world of PAT, and continuous process monitoring, the in process testing will be expected to be fully validated.