Stability Program. Sanofi-aventis US or its designated Affiliate will perform stability study on the final validation batches on stability program following its internal established programs based on typical ICH stability guidelines for Zone I & II climate. The stability study will be carried out at 25C/60%RH through product expiry and under accelerated conditions at 40C/75%RH up to 6 months. Samples will be stored at 30C/65%RH but will not be tested unless required (subject to an additional fee). The program includes bulk tablets hold time study (up to 6 months), three validation batches carried out to a 5 year program, and one batch per year for routine study to support product shelf life confirmation. If there are requests to include additional conditions that are not typically required for the conditions mentioned above, Horizon will bear the added cost to support such additional program. Sanofi-aventis will develop stability protocol following its internal procedures. The protocol will be jointly reviewed and approved by Horizon Regulatory prior to commencing the validation stability study. Specific testing requirements and time-points will be provided in the stability protocol which should include all necessary regulatory requirements to register the Facility as the manufacturing site.
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Sources: Technical Transfer Agreement (Horizon Pharma, Inc.), Technical Transfer Agreement (Horizon Pharma, Inc.)