Home › Forums › General Discussion › Start date for annual stability studies
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For annual (samples stored at long term condition) stability studies, do you base your start date on date of manufacture or date in chamber? Please provide rationale for why or why not you choose one over the other.
Perenniel question within the Stability Community; Regulatory authorities have leaned toward date of manufacture, but there is a strong case for date in chamber if samples have not been under rigorous control (conditions as well as security and documentation). Release data often does double duty as T0 data when less than 30 days go by before going into the chamber. Over 30 days, retesting to set a “Chamber T0” and then paying attention to end of shelf-life vs end of study test points may be an acceptble way to go with scientific justification and approval from your Quality and Regulatory folks.
I would venture that most companies base the timing of their annual studies on date in chamber, however it has always been date of manufacture for me. It would be great to hear more opinions. That said, a key driver for this should be in the filed stability commitment. For example, if the protocol says that the product will be exposed to 25C/60%RH for 24 months, that could be taken to imply that the study will start from date in chamber. That said, it poses a lot of problems with timing since you will inevitably have to insert an expiry interval and then test beyond expiry it what could be argued to be meaningless data since you’re probably not going to recall product based on testing of expired product. So, minor tweaking of the protocol wording to indicate date of manufacture and a process for getting material packaged and into the chamber in a very timely manner (at least before the first interval) can be a very effective cost savings. It is also very defensible since your product prior to being placed in the chamber was under normal supply change storage conditions. But, for Zone IVb products at 30C/75%RH, one should consider starting from date in chamber, unless your warehouse storage prior to stability was actually at or justifiably near 30C. This topic can go back and forth forever.
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