Amount of sample specified in respective protocol should be incubated including quantity for analysis as well as for investigation purpose in case of OOT/OOS results.
All the samples incubated should be properly labeled with condition, orientation and stability intervals for traceability, and to facilitate the reconciliation while withdrawing sample from incubator.
Stability protocol shall be prepared as per SOP -Stability Protocol, Template and Specification Preparation”.
Stability sample shall be withdrawn and analyzed as per the stipulated time window/ due date defined in the protocol.
Any failure (OOS/OOT) observed during stability study shall be investigated and documented as per investigation procedure specified in the SOP of OOS and OOT investigation respectively
Whenever any batch is found failing in stability study after expiry interval, then there is no need to perform analysis of further intervals. For such products, Stability Study Protocol is to be revised and future stability batches are to be monitored only up to expiry interval or up to the interval till the product is stable whichever is later.
The status of on-going stability should be periodically reviewed (at least once a year). The stability study followed, number of batches incubated, reason for monitoring, condition of stability incubator/walk-in chamber, any excursion or deviation of stability trend, stability failure etc. but not limited to, should be evaluated and appropriate action if required should be initiated.
Conduct stability testing on the dosage form packaged in the container closure system proposed for marketing (including, as appropriate, any secondary packaging and container label).
Consider first three batches for Long term, and Accelerated stability. (“First” means the product is manufactured for the first time at the location). Batches should be of the same formulation and packaged in the same container closure system as proposed for marketing.
Significant Change :
A 5% change in assay from its initial value or failure to meet the acceptance criteria for potency.
Any degradation products exceeding its acceptance criteria.
Failure to meet the acceptance criteria for appearance, physical attributes and functionality test (e.g. colour, phase separation, caking, hardness ) however some changes in physical attributes (e.g. softening of suppositories, melting of creams, disfiguration of capsules) may be expected under accelerated conditions and not to be considered as a significant change.
As appropriate for the dosage form :
Failure to meet the acceptance criteria for PH; or
Failure to meet the acceptance criteria for dissolution for 12 dosage units.
If “significant change “observed at 6 months testing of accelerated condition, then conduct additional testing at the intermediate storage condition up to 12 months, and same shall be considered at the time of shelf life evaluation.
If significant change or failure of any attribute in one or more exhibit batches, intermediate storage condition study shall be performed for all three exhibit batches / all the test parameters of particular pack.
Stability Schedule Verification:
Stability In charge or designee shall prepare the monthly stability schedule monitoring manually as well as in soft copy as per Annexure -6.
