Module 3 Presentations

07/05/2024

In this presentation we have covered:

Recommended references

• Dossier requirements and specification definitions • (ICH Q6A) • Adjusting specifications during development • Staged Risk • Justification of Specifications • How does Real Time Release affect the control strategy • Comparison of RTR with Traditional Control Strategy

• ICH Q6A: https://database.ich.org/sites/default/files/Q6A_Guideline.pdf • ICH Q6B: https://database.ich.org/sites/default/files/Q6B_Guideline.pdf • ICH Q3A(R2): https://database.ich.org/sites/default/files/Q3A_R2__Guideline.pdf • ICH Q3B(R2): https://database.ich.org/sites/default/files/Q3B_R2__Guideline.pdf • ICH Q3C(R6): https://database.ich.org/sites/default/files/Q3C R6_Guideline_ErrorCorrection_2019_0410_0.pdf • ICH Q3D(R1): https://database.ich.org/sites/default/files/Q3D R1EWG_Document_Step4_Guideline_2019_0322.pdf • ICH Q8(R2): https://database.ich.org/sites/default/files/Q8_R2_Guideline.pdf • ICH Q9: https://database.ich.org/sites/default/files/Q9_Guideline.pdf • ICH Q10: https://database.ich.org/sites/default/files/Q10_Guideline.pdf • ICH Q11: http://www.ich.org/products/guidelines/quality/article/quality guidelines.html • ICH Q12: https://database.ich.org/sites/default/files/Q11_Guideline.pdf • Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System: http://www.fda.gov/cder/guidance/3618fnl.pdf • EMA Guideline on Real Time Release Testing (Formerly Guideline on Parametric Release): https://www.ema.europa.eu/en/documents/scientific guideline/guideline-real-time-release-testing-formerly-guideline parametric-release-revision-1_en.pdf

Developing Specifications for the Active Ingredient

The Organisation for Professionals in Regulatory Affairs

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CMC Project Management

The Organisation for Professionals in Regulatory Affairs

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