Hello there,
To multidose product, when do we need to carry out in-use stability study? I wonder whether it is a compulsory study or not?
Thank you for reading my topic.
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Multi dose containers which - by nature of their physical form and chemical composition - due to repeated opening and closing, may pose at risk to its content with regard to microbiological contamination, proliferation and/or physico chemical degradation once the closure system has been breached.
“As far as possible the test should be designed to simulate the use of the product in practice
taking into consideration the filling volume of the container and any dilution/reconstitution
before use. At intervals comparable to those which occur in practice appropriate quantities
should be removed by the withdrawal methods normally used and described in the product
literature” EMEA Guideline
“Recommendations listed in ICH Q1A(R2), section II, B, 7, Storage Conditions (2.2.7) should be followed for all three batches. These studies should be performed when the drug product is labeled for reconstitution or dilution.” - ANDA: Guideline on Stability Testing of Drug Substances and Products
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Very well answered by @dushyant3044.
EMEA guidance mandates you to go for the stability testing of multidose containers. The guidances very well explains you the criteria of selection of batches, test parameters etc.
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