Module 3 - Strategic case studies in practice

ICH Q12 Guideline

CTD SECTION

SECTION TITLE

ESTABLISHED CONDITIONS – General List with notes

3.2.P.8.1

Stability Summary and Conclusion

Drug product storage conditions and shelf-life Where applicable, in-use storage conditions and shelf-life

3.2.P.8.2

Post-approval stability protocol and stability commitment

Supportive information (also see Chapter 3, section 3.2.2)

3.3 P.8.3

Stability data

Supportive information

3.2.A

APPENDICES

3.2.A.1 3.2.A.2

Facilities and equipment Adventitious agents safety evaluation

Regional regulation and guidance apply

Supportive information (Applicable to biotechnological/biological products)

3.2.A.3

Excipients

Supportive information

3.2.R

REGIONAL INFORMATION Not Applicable

Regional regulation and guidance apply.

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