Spring Intro 2023

03/03/2023

Conclusions

• Where to find information? • How and what to submit?

• What do regulators expect to see in Module 3? • Understand the most common deficiencies identified during assessment of the DS and DP sections of MAAs

• Brief overview of QbD / PAT

03/03/2023

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Conclusions

• Fill in all sections. If any section is not applicable please justify why it is not applicable • Compliance with guidance. If you are deviating from any guidance documents a justification should be provided • Impurities: For substances with a Ph. Eur. monograph ensure that the documentation submitted is in line with information provided in Ph. Eur. (e.g. impurity limits, polymorphism etc.)

03/03/2023

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