Site-Specific Stability Data for Drug and Biologic Applications

Site-Specific Stability Data for Drug and Biologic Applications 

In principle, primary stability batches should be made at the intended commercial site. If the primary stability batches are not made at the intended commercial site, 

A drug substance should be adequately characterized (i.e., results of chemical, physical, and, when applicable, biological testing). Material produced at different sites should be of comparable quality. In general, 3 to 6 months of stability data on one to three site-specific drug substance batches, depending on the availability of sufficient primary stability data from another site, should be provided at the time of application submission. 

Other factors, such as lack of experience at the new site in a particular dosage form or difference in the environmental conditions between the sites, can potentially affect the quality or stability of a drug product. Therefore, one site-specific batch may not be sufficient in these cases. More than one site-specific batch may be needed for a drug substance or product that is intrinsically unstable. 

Although one site-specific batch may be sufficient under certain situations, the data so generated, particularly if limited to accelerated studies, may not be amenable to statistical analysis for the establishment of a retest period or expiration dating period. Instead, the single site-specific batch may serve only to verify the stability profile of a drug substance or product that has been established based on primary stability batches at a pilot plant. 

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See also in sourсe #XX -- [ ]

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