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Module 3

PUBERGEN 5000 IU
(Chorionic Gonadotrophin Injection BP, 5000 IU/ 2 ml Vial)

3.1 Table of Contents of Module 3

3.1 Table of Contents of Module 3 Volume x of y/


Page x to y
3.2 Body of Data
3.2.S DRUG SUBSTANCE Volume 1 of 3

(Chorionic Gonadotrophin, BBT-Biotech GmbH)

3.2.S.1 General Information


3.2.S.1.1 Nomenclature Page 1 to 1
3.2.S.1.2 Structure Page 1 to 2
3.2.S.1.3 General Properties Page 1 to 3
3.2.S.2 Manufacture
3.2.S.2.1 Manufacturer(s) Page 1 to 1
3.2.S.2.2 Description of Manufacturing Process and Page 1 to 11
Process Controls
3.2.S.2.3 Control of Materials Page 1 to 7
3.2.S.2.4 Controls of Critical Steps and Intermediates Page 1 to 2
3.2.S.2.5 Process Validation and/or Evaluation Page 1 to 14
3.2.S.2.6 Manufacturing Process Development Page 1 to 1
3.2.S.3 Characterisation
3.2.S.3.1 Elucidation of Structure and Other Page 1 to 1
Characteristics
3.2.S.3.2 Impurities Page 1 to 3
3.2.S.4 Control of Drug Substance
3.2.S.4.1 Specification Page 1 to 5
3.2.S.4.2 Analytical Procedures Page 1 to 57
3.2.S.4.3 Validation of Analytical Procedures Page 1 to 2
3.2.S.4.4 Batch Analyses Page 1 to 8
3.2.S.4.5 Justification of Specification Page 1 to 1
3.2.S.5 Reference Standards or Materials Page 1 to 4
3.2.S.6 Container Closure System Page 1 to 14

Sanzyme Limited India. Page 1 of 6


Module 3

PUBERGEN 5000 IU
(Chorionic Gonadotrophin Injection BP, 5000 IU/ 2 ml Vial)

3.1 Table of Contents of Module 3

3.1 Table of Contents of Module 3 Volume x of y/


Page x to y
3.2.S.7 Stability Volume 1 of 3
3.2.S.7.1 Stability Summary and Conclusions Page No. 1 to 2
3.2.S.7.2 Post-approval Stability Protocol and Stability Page No. 1 to 1
Commitment
3.2.S.7.3 Stability Data Page No. 1 to 4
3.2.S DRUG SUBSTANCE Volume 1 of 3

(Chorionic Gonadotrophin, Shanghai Techwell


Biopharmaceutical Co., Ltd.)

3.2.S.1 General Information Page 1 to 1


3.2.S.1.1 Nomenclature Page 1 to 1
3.2.S.1.2 Structure Page 1 to 1
3.2.S.1.3 General Properties
3.2.S.2 Manufacture
3.2.S.2.1 Manufacturer(s) Page 1 to 1
3.2.S.2.2 Description of Manufacturing Process and Page 1 to 5
Process Controls
3.2.S.2.3 Control of Materials Page 1 to 4
3.2.S.2.4 Controls of Critical Steps and Intermediates Page 1 to 2
3.2.S.2.5 Process Validation and/or Evaluation Page 1 to 2
3.2.S.2.6 Manufacturing Process Development Page 1 to 1
3.2.S.3 Characterisation
3.2.S.3.1 Elucidation of Structure and Other Page 1 to 1
Characteristics
3.2.S.3.2 Impurities Page 1 to 1
3.2.S.4 Control of Drug Substance
3.2.S.4.1 Specification Page 1 to 4
3.2.S.4.2 Analytical Procedures Page 1 to 13
3.2.S.4.3 Validation of Analytical Procedures Page 1 to 1
3.2.S.4.4 Batch Analyses Page 1 to 9

Sanzyme Limited India. Page 2 of 6


Module 3

PUBERGEN 5000 IU
(Chorionic Gonadotrophin Injection BP, 5000 IU/ 2 ml Vial)

3.1 Table of Contents of Module 3

3.1 Table of Contents of Module 3 Volume x of y/


Page x to y
Volume 1 of 3
3.2.S.4.5 Justification of Specification Page 1 to 1
3.2.S.5 Reference Standards or Materials Page 1 to 1
3.2.S.6 Container Closure System Page 1 to 1
3.2.S.7 Stability
3.2.S.7.1 Stability Summary and Conclusions Page 1 to 2
3.2.S.7.2 Post-approval Stability Protocol and Stability Page 1 to 1
Commitment
3.2.S.7.3 Stability Data Page 1 to 4
3.2.P DRUG PRODUCT Volume 2 of 3

[PUBERGEN 5000 IU (Chorionic Gonadotrophin Injection


BP, 5000 IU/ 2 ml Vial)

3.2.P.1 Description and Composition of the Drug Product Page 1 to 2


3.2.P.2 Pharmaceutical Development Page 1 to 37
3.2.P.2.1 Components of the Drug Product
3.2.P.2.1.1 Drug Substance Page 1 to 2
3.2.P.2.1.2 Excipients Page 3 to 6
3.2.P.2.2 Finished product
3.2.P.2.2.1 Formulation Development Page 7 to 22
3.2.P.2.2.2 Overages Page 22 to 22
3.2.P.2.2.3 Physicochemical and Page 22 to 23
Biological Properties
3.2.P.2.3 Manufacturing Process Development Page 24 to 35
3.2.P.2.4 Container Closure System Page 36 to 36
3.2.P.2.5 Microbiological Attributes Page 36 to 36
3.2.P.2.6 Compatibility Page 37 to 37
3.2.P.3 Manufacture
3.2.P.3.1 Manufacturer(s) Page 1 to 1
3.2.P.3.2 Batch Formula Page 1 to 2

Sanzyme Limited India. Page 3 of 6


Module 3

PUBERGEN 5000 IU
(Chorionic Gonadotrophin Injection BP, 5000 IU/ 2 ml Vial)

3.1 Table of Contents of Module 3

3.1 Table of Contents of Module 3 Volume x of y/


Page x to y
3.2.P.3.3 Description of Manufacturing Process and Volume 2 of 3
Process Control Page 1 to 10
3.2.P.3.4 Controls of Critical Steps and Intermediates Page 1 to 2
3.2.P.3.5 Process validation and/or evaluation. Page 1 to 48
3.2.P.4 Control of excipients
3.2.P.4.1 Specifications Page 1 to 10
3.2.P.4.2 Analytical Procedures Page 1 to 45
3.2.P.4.3 Validation of Analytical Procedures Page 1 to 1
3.2.P.4.4 Justification of Specifications Page 1 to 18
3.2.P.4.5 Excipients of Human or Animal origin Page 1 to 1
3.2.P.4.6 Novel Excipients. Page 1 to 1
3.2.P.5 Control of drug product
3.2.P.5.1 Specification(s) Page 1 to 4
3.2.P.5.2 Analytical Procedures Page 1 to 8
3.2.P.5.3 Validation of Analytical Procedures Page 1 to 1
3.2.P.5.4 Batch Analyses. Page 1 to 7
3.2.P.5.5 Characterisation of Impurities Page 1 to 1
3.2.P.5.6 Justification of specification(s) Page 1 to 2
3.2.P.6 Reference Standards or Materials Page 1 to 6
3.2.P.7 Container Closure System Page 1 to 81
3.2.P.8 Stability
3.2.P.8.1 Stability Summary and Conclusion Page 1 to 3
3.2.P.8.2 Post approval Stability Protocol and Page 1 to 7
Stability Commitment
3.2.P.8.3 Stability Data Page 1 to 7

Sanzyme Limited India. Page 4 of 6


Module 3

PUBERGEN 5000 IU
(Chorionic Gonadotrophin Injection BP, 5000 IU/ 2 ml Vial)

3.1 Table of Contents of Module 3

3.1 Table of Contents of Module 3 Volume x of y/


Page x to y
3.2.P DRUG PRODUCT Volume 3 of 3
(Sodium Chloride 0.9% w/v Injection BP, 1 mL/ 2 mL
ampoule)
3.2.P.1 Description and Composition of the Drug Product Page 1 to 1
3.2.P.2 Pharmaceutical Development Page 1 to 11
3.2.P.2.1 Components of the Drug Product
3.2.P.2.1.1 Drug Substance Page 1 to 1
3.2.P.2.1.2 Excipients Page 1 to 1
3.2.P.2.2 Finished product
3.2.P.2.2.1 Formulation Development Page 2 to 2
3.2.P.2.2.2 Overages Page 2 to 2
3.2.P.2.2.3 Physicochemical and Biological Page 2 to 2
Properties
3.2.P.2.3 Manufacturing Process Development Page 3 to 10
3.2.P.2.4 Container Closure System Page 10 to 10
3.2.P.2.5 Microbiological Attributes Page 11 to 11
3.2.P.2.6 Compatibility Page 11 to 11
3.2.P.3 Manufacture
3.2.P.3.1 Manufacturer(s) Page 1 to 1
3.2.P.3.2 Batch Formula Page 1 to 1
3.2.P.3.3 Description of Manufacturing Process and Page 1 to 9
Process Control
3.2.P.3.4 Controls of Critical Steps and Intermediates Page 1 to 1
3.2.P.3.5 Process validation and/or evaluation. Page 1 to 43
3.2.P.4 Control of excipients
3.2.P.4.1 Specifications Page 1 to 8
3.2.P.4.2 Analytical Procedures Page 1 to 33
3.2.P.4.3 Validation of Analytical Procedures Page 1 to 1
3.2.P.4.4 Justification of Specifications Page 1 to 7

Sanzyme Limited India. Page 5 of 6


Module 3

PUBERGEN 5000 IU
(Chorionic Gonadotrophin Injection BP, 5000 IU/ 2 ml Vial)

3.1 Table of Contents of Module 3

3.1 Table of Contents of Module 3 Volume x of y/


Page x to y
Volume 3 of 3
3.2.P.4.5 Excipients of Human or Animal origin Page 1 to 1
3.2.P.4.6 Novel Excipients. Page 1 to 1
3.2.P.5 Control of drug product
3.2.P.5.1 Specification(s) Page 1 to 3
3.2.P.5.2 Analytical Procedures Page 1 to 7
3.2.P.5.3 Validation of Analytical Procedures Page 1 to 1
3.2.P.5.4 Batch Analyses. Page 1 to 4
3.2.P.5.5 Characterisation of Impurities Page 1 to 1
3.2.P.5.6 Justification of specification(s) Page 1 to 1
3.2.P.6 Reference Standards or Materials Page 1 to 1
3.2.P.7 Container Closure System Page 1 to 20
3.2.P.8 Stability
3.2.P.8.1 Stability Summary and Conclusion Page 1 to 3
3.2.P.8.2 Post approval Stability Protocol and Page 1 to 7
Stability Commitment
3.2.P.8.3 Stability Data Page 1 to 7
3. 2.A APPENDICES
3.2.A.1 Facilities and Equipment Page 1 to 5
3.2.A.2 Adventitious Agents Safety Evaluation Page 1 to 1
3.2.A.3 Excipients Page 1 to 1
3. 2.R Regional Information
3.2.R.1 Process Validation Scheme for the Drug Product Page 1 to 70
3.2.R.2 Medical Device Page 1 to 1
3.2.R.3 Certificate(s) of suitability Page 1 to 1
3.2.R.4 Medicinal products containing or using in the Page 1 to 3
manufacturing process materials of animal and/or
human origin

Sanzyme Limited India. Page 6 of 6