Module 3 - Strategic case studies in practice

ICH Q12 Guideline

CTD SECTION

SECTION TITLE

ESTABLISHED CONDITIONS – General List with notes

3.2.S.4.5

Justification of specification

Supportive information

3.2.S.5

Reference Material

Reference Material specification (e.g., test, elements of analytical procedure, where appropriate, and acceptance criteria)

3.2.S.6

Container Closure

Material of construction and specification

3.2.S.7

Stability

3.2.S.7.1

Stability Summary and Conclusions

Drug Substance storage conditions and shelf-life (or Retest period for chemicals)

3.2.S.7.2

Post-approval stability protocol and stability commitments

Supportive information (also see Chapter 3, section 3.2.2)

3.2.S.7.3

Stability data

Supportive information

3.2.P

DRUG PRODUCT

3.2.P.1

Description and Composition of Drug Product Pharmaceutical development

Drug Product qualitative and quantitative composition

3.2.P.2

3.2.P.2.1

Components of the drug product

3.2.P.2.2

Drug product

3.2.P.2.3

Manufacturing process development Container closure system Microbiological attributes

Supportive information

3.2.P.2.4 3.2.P.2.5 3.3.P.2.6

Compatibility Manufacture

3.2.P.3

26