Spring Intro 2023

03/03/2023

• Stability • Batches not representative of commercial scale • Insufficient data to support retest period • Out of specification results not discussed • No confirmation that stability batches represent the current process • No batch size / container closure system described • Stability results stating ‘complies’ instead of individual values (no possibility to determine trending) Common Deficiencies – 3.2.S.7

03/03/2023

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Any questions so far?

03/03/2023

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