M 4 QCommon Technical Document for the …

1 European Medicines Agency 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 85 75 Fax (44-20) 75 23 70 40 E-mail: EMEA 2006 Reproduction and/or distribution of this Document is authorised for non commercial purposes only provided the EMEA is acknowledged July 2003 CPMP/ICH/2887/99 - Quality ICH Topic M 4 Q Common Technical Document for the registration of Pharmaceuticals for Human Use - Quality Step 5 COMMON Technical Document FOR THE registration OF PHARMACEUTICALS FOR HUMAN USE QUALITY OVERALL SUMMARY OF MODULE 2 AND MODULE 3.

2 QUALITY (CPMP/ICH/2887/99 - Quality) TRANSMISSION TO CPMP July 2000 RELEASE FOR CONSULTATION July 2000 DEADLINE FOR COMMENTS September 2000 TRANSMISSION TO CPMP FOR INFORMATION November 2000 RELEASE FOR INFORMATION November 2000 NUMBERING AND SECTION HEADERS EDITED FOR CONSISTENCY AND USE IN E-CTD AS AGREED BY ICH STEERING COMMITTEE September 2002 TRANSMISSION TO CPMP AND RELEASE FOR INFORMATION February 2003 DATE FOR IMPLEMENTATION July 2003 Note: The sequence of M4 Common Technical Document for the registration of Pharmaceuticals for Human Use is: M4 - Organisation of Common Technical Document M4 Quality - Quality overall summary of Module 2 and Module 3: Quality M4 Safety - Nonclinical Overview and Nonclinical Summaries of Module 2 and Organisation of Module 4 M4 Efficacy - Clinical overview and Clinical summary of Module 2 and Module 5: Clinical Study reports EMEA 2006 2 The Document as presented may be subject to further editorial changes and is for information only.

3 Details on how to prepare a submission dossier based on the CTD format including information on the content of Module I are included in the revision of the Notice to Applicants. EMEA 2006 3 COMMON Technical Document FOR THE registration OF PHARMACEUTICALS FOR HUMAN USE: QUALITY QUALITY OVERALL SUMMARY OF MODULE 2 MODULE 3: QUALITY TABLE OF CONTENTS MODULE 2: COMMON Technical Document SUMMARIES ..7 : QUALITY OVERALL SUMMARY (QOS) ..7 INTRODUCTION ..7 DRUG SUBSTANCE (NAME, MANUFACTURER) ..7 General Information (name, manufacturer).

4 7 Manufacture (name, manufacturer) ..7 Characterisation (name, manufacturer) ..8 Control of Drug Substance (name, manufacturer)..8 Reference Standards or Materials (name, manufacturer) ..8 Container Closure System (name, manufacturer)..8 Stability (name, manufacturer) ..8 DRUG PRODUCT (NAME, DOSAGE FORM)..8 Description and Composition of the Drug Product (name, dosage form) ..8 Pharmaceutical Development (name, dosage form) ..9 Manufacture (name, dosage form)..9 Control of Excipients (name, dosage form).

5 9 Control of Drug Product (name, dosage form) ..9 Reference Standards or Materials (name, dosage form)..9 Container Closure System (name, dosage form) ..9 Stability (name, dosage form) ..9 Facilities and Equipment (name, manufacturer)..9 Adventitious Agents Safety Evaluation (name, dosage form and manufacturer) ..9 Excipients ..10 REGIONAL MODULE 3 : QUALITY ..11 TABLE OF CONTENTS OF MODULE 3 ..11 BODY OF EMEA 2006 4 DRUG SUBSTANCE (NAME, MANUFACTURER)..11 General Information (name, manufacturer) ..11 Nomenclature (name, manufacturer).

6 11 Structure (name, manufacturer) ..11 General Properties (name, manufacturer) ..12 Manufacture (name, manufacturer) ..12 Manufacturer(s) (name, manufacturer) ..12 Description of Manufacturing Process and Process Controls (name, manufacturer) ..12 Control of Materials (name, manufacturer) ..13 Controls of Critical Steps and Intermediates (name, manufacturer)..14 Process Validation and/or Evaluation (name, manufacturer).

7 14 Manufacturing Process Development (name, manufacturer)..14 Characterisation (name, manufacturer) ..15 Elucidation of Structure and other Characteristics (name, manufacturer) ..15 Impurities (name, manufacturer)..15 Control of Drug Substance (name, manufacturer)..15 Specification (name, manufacturer) ..15 Analytical Procedures (name, manufacturer)..15 Validation of Analytical Procedures (name, manufacturer).

8 16 Batch Analyses (name, manufacturer) ..16 Justification of Specification (name, manufacturer) ..16 Reference Standards or Materials (name, manufacturer) ..16 Container Closure System (name, manufacturer)..16 Stability (name, manufacturer) ..16 Stability Summary and Conclusions (name, manufacturer) ..16 Post-approval Stability Protocol and Stability Commitment (name, manufacturer) ..16 Stability Data (name, manufacturer) ..16 DRUG PRODUCT (NAME, DOSAGE FORM).

9 17 Description and Composition of the Drug Product (name, dosage form) ..17 Pharmaceutical Development (name, dosage form) ..17 Components of the Drug Product (name, dosage form) ..17 Drug Substance (name, dosage form)..17 Excipients (name, dosage form) ..17 Drug Product (name, dosage form) ..18 EMEA 2006 5 Formulation Development (name, dosage form) ..18 Overages (name, dosage form) ..18 Physicochemical and Biological Properties (name, dosage form) ..18 Manufacturing Process Development (name, dosage form).

10 18 Container Closure System (name, dosage form)..18 Microbiological Attributes (name, dosage form)..18 Compatibility (name, dosage form) ..18 Manufacture (name, dosage form)..18 Manufacturer(s) (name, dosage form)..18 Batch Formula (name, dosage form)..19 Description of Manufacturing Process and Process Controls (name, dosage form) 19 Controls of Critical Steps and Intermediates (name, dosage form) ..19 Process Validation and/or Evaluation (name, dosage form) ..19 Control of Excipients (name, dosage form).