Module 3 - Strategic case studies in practice

ICH Q12 Guideline

CTD SECTION

SECTION TITLE

ESTABLISHED CONDITIONS – General List with notes

3.2.P.4.6

Novel excipients

(If Novel Excipient Specification is not described in 3.2.P.4.1) Novel Excipient Specification For each Quality Attribute on the specification

Test Method

• •

Acceptance Criteria

3.2.P.5

Control of Drug Product

3.2.P.5.1

Specification(s)

Drug Product Specification For each Quality Attribute on the specification

Test Method

• •

Acceptance Criteria

3.2.P.5.2

Analytical Procedures

Reference is made to Chapter 3, section 3.2.3.2

3.2.P.5.3

Validation of analytical procedures

Supportive information

3.3.P.5.4

Batch analyses

3.2.P.5.5

Characterisation of impurities

Supportive information

3.2.P.5.6

Justification of specification(s)

3.2.P.6

Reference Materials

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

3.2.P.7

Container Closure System

Material of construction and specification Where applicable, supplier/manufacturer of primary container closure system

3.2.P.8

Stability

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