synthetic impurities +finished product validation

[martinamarie]

Hi, I have to do a gmp validation of a finished product.

There are only synthetic impurities in the drug substance used in the manufacture of the finished product.

Therefore we are only using these impurites in the resolution/peak id solution.

Do these impurities require full characterization, ie chromatographic purity and spectroscopic analysis before use?

Thanks Martina

[krickos]

Hi

The ICH Q2 guideline calls for "well characteriazed reference materials with a documented purity, the degree of purity depends of the intended use". a bit fluffy but if you for example check ICH Q7a § 11.17-19 and the definitions of primary/secondary reference standards in the end of Q7a, that would likely give you some idea.

Unless you can assign the impurities as "secondary reference standard" I doubt that you can completly rule out verification of Identity by NMR/MS etc. Contract labs for reference standards usually attach MS/NMR data to the CoA.