Module 3 - Strategic case studies in practice

MODULE 3 – QUALITY

CTD

EU CTD (NTA, Vol. 2B, Edition 2001)

NTA, Vol. 2B (Edition 1998)

NTA

3.2.S.4.3 3.2.S.4.4 3.2.S.4.5

Validation of analytical procedures

Development Chemistry: Analytical Validation

II C 1.2.5 II C 1.2.7 II C 1.2.5

Batch analyses

Batch analysis

Justification of Specification

Development Chemistry: Comments on the choice of routine tests and standards Development chemistry: Full characterization of the primary reference material Batch analysis: Reference material

3.2.S.5

Reference Standards or Materials

II C 1.2.5 II C 1.2.7

Container Closure System

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3.2.S.6

3.2.S.7 Stability

Stability Tests on Active Substance(s)

II F 1

3.2.P

DRUG PRODUCT

3.2.P.1

Description and composition of the drug product

Composition and container (brief description) Development Pharmaceutics and clinical trial formulae

II A1 II A2 II A 4 II A3 II B3

3.2.P.2

Pharmaceutical Development

3.2.P.2.4 Controls and critical steps and intermediates

Manufacturing process (including in-process control and phamraceutical assembly process) Control tests on intermediate products

II D II B

3.2.P.3

Manufacture

Method of Preparation

3.2.P.3.1 3.2.P.3.2 3.2.P.3.3

Manufacturer(s) Batch formula

Administrative Data Manufacturing Formula

I A

II B 1 II B 2

Description of Manufacturing Process and Process Controls Controls of critical steps and intermediates

Manufacturing Process (including In-process Control and Pharmaceutical Assembly Process) Manufacturing Process (including In-process Control and Pharmaceutical Assembly Process)

3.2.P.3.4

II B 2

3.2.P.3.5

Process validation and / or evaluation

Validation of the Process

II B 3 II C 2

3.2.P.4

Control of excipients

Excipients(s)

3.2.P.4.1 3.2.P.4.2 3.2.P.4.3 3.2.P.4.4 3.2.P.4.5 3.2.P.4.6

Specifications

Specifications and routine tests Specifications and routine tests

II C 2.1 II C 2.1 II C 2.2 II C 2.2

Analytical procedures

Validation of analytical procedures

Scientific data Scientific data

Justification of specifications

Excipients of human or animal origin

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Novel Excipients (ref to A 3)

Excipient(s) not described in a pharmacopoeia Scientific data

II C 2.2.1 II C 2.2

3.2.P.5 Control of drug product

Control Tests on the Finished Product

II E

3.2.P.5.1

Specification(s)

Product specifications Quality specifications for the proposed shelf life

II E 1.1 II F 2 II E 1.2 II E 2.1 II E 2.2

3.2.P.5.2 3.2.P.5.3 3.2.P.5.4 3.2.P.5.5 3.2.P.5.6

Analytical Procedures

Control Methods

Validation of Analytical Procedures

Analytical validation of methods

Batch analyses

Batch analysis

Characterisation of Impurities Justification of specification(s)

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Comments on the choice of routine tests and standards

II E 2.1

3.2.P.6 3.2.P.7 3.2.P.8

Reference Standards or Materials

Batch analysis: Reference material

II E 2.2

Packaging Material (Immediate Packaging)

Container Closure System

II C 3 II F 2

Stability

Stability Tests on the Finished Product

3.2.A

APPENDICES

3.2.A.1 3.2.A.2 3.2.A.3

Facilities and Equipment

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Adventitious Agents Safety Evaluation

Excipients

3.2.R

REGIONAL INFORMATION LITERATURE REFERENCES

Validation of the process OTHER INFORMATION

-II B3--

3.3

II Q

NTA, Vol. 2B-CTD, foreword & introduction, edition June 2006

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