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Appearing somewhat out of place the control strategy section also includes specific advice relating to the control of degradation products. The guideline states the need to understand the degradation pathway for a mutagenic degradant and its relevance to the DS and DP manufacturing processes and/or their proposed packaging and storage conditions. It also articulates how either accelerated stability studies (e.g. 40 °C/75% relative humidity, six months) or kinetically equivalent shorter term stability studies at higher temperatures in the proposed commercial package may be used to determine the relevance of the degradation pathway prior to initiating longer term stability studies. This of course makes perfect sense, there being a considerable risk in relying on long‐term studies to provide the required assurance of control. Finding out control is inadequate at a late stage, i.e. at the end of long‐term stability studies, is likely to have a serious impact. Earlier identification of any potential issue would certainly allow more time to consider formulation/packaging options for control. Again, as with synthetic impurities, if formulation development and packaging design options are unable to control mutagenic degradation product levels to less than the acceptable limit, it may be possible to justify a higher limit based on a risk/benefit analysis.