Stability Testing Question & Answers; In-use Testing Requirements

How many batches shall be subjected for In-use stability testing during stability study?

1.According to EMA Guidance “Note for Guidance on In-use Stability Testing of Human Medicinal Products” “A minimum of two batches, at least pilot scale batches, should be subjected to the test. At least one of the batches should be chosen towards the end of its shelf life. If such results are not available, one batch should be tested at the final point of the submitted stability studies”. “If the product is to be supplied in more than one container size or in different strengths, the in-use stability test should be applied to the product which presents the greatest susceptibility to change. The choice of the tested product should always be justified”. 2.According to USFDA Guidance “ANDA Submissions — Content and Format Guidance for Industry” “One-time in-use stability studies for oral liquids and other dosage forms (e.g., a solution to be used within a certain period of opening the container per labeling instructions, compatibility with a dropper when provided as part of the container closure system), as applicable”.