Spring Intro 2023

28/03/2023

3.2.P Drug Product 3.2.P.8 Drug Product Stability

Latin America /Asia : No regionally harmonized guideline Zone IVb, 30°C/75%RH required in some markets Full term data may be needed (can sometimes be provided during review) Stability data may be needed from the commercial site Some markets need stability data from actual commercial batches ● Including all sites being registered ● For multiple DS sites, a DP stability study is needed using DS from every site included in the registration ● Including the primary packaging site

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3.2.A Appendices

3.2.A.1 Facilities and Equipment (for Biotech applications)  Diagram of manufacturing flow  Other products manufactured in same area  Summary of product contact equipment and other use  Cleaning procedures and measures to prevent cross contamination

3.2.A.2 Adventitious agents safety evaluation  Non viral  Viral 3.2.A.3 Excipients  Information on novel excipients – follow format of Module 3

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