Ctd Module 3
COMMON TECHNICAL DOCUMENT
CEFTEN (CEFTIBUTEN CAPSULES 400 MG)
MODULE 3
QUALITY
3.1 MODULE 3 TABLE OF CONTENT Sr. No. | Contents | Page No. | 3.1 | MODULE 3 TABLE OF CONTENT | 2 | 3.2 | BODY OF DATA | 4 | 3.2.S | Drug Substance | 4 | 3.2.P | Drug Product | 5 | 3.2.P.1 | Description and Composition of the Drug Product | 5 | 3.2.P.2 | Pharmaceutical Development | 6 | 3.2.P.2.1 | Components of the Drug Product | 8 | 3.2.P.2.1.1 | Drug Substance | 8 | 3.2.P.2.1.2 | Excipients | 10 | 3.2.P.2.2 | Drug Product | 11 | 3.2.P.2.2.1 | Formulation Development | 11 | 3.2.P.2.2.2 | Overages | 13 | 3.2.P.2.2.3 | Physicochemical and Biological Properties | 14 | 3.2.P.2.3 | Manufacturing Process Development | 16 | 3.2.P.2.4 | Container Closure System | 18 | 3.2.P.2.5 | Microbiological Attributes | 19 | 3.2.P.2.6 | Compatibility | 20 | 3.2.P.3 | Manufacture | 21 | 3.2.P.3.1 | Manufacturer(s) | 21 | 3.2.P.3.2 | Batch Formula | 23 | 3.2.P.3.3 | Description of Manufacturing Process and Process Controls | 24 | 3.2.P.3.4 | Controls of Critical Steps and Intermediates | 29 | 3.2.P.3.5 | Process Validation and/or Evaluation | 30 | 3.2.P.4 | Control of Excipients | 42 | 3.2.P.4.1 | Specifications | 43 | 3.2.P.4.2 | Analytical Procedures | 51 | 3.2.P.4.3 | Validation of Analytical Procedures | 68 | 3.2.P.4.4 | Justification of Specifications | 69 | 3.2.P.4.5 | Excipients of Human or Animal Origin | 70 | 3.2.P.4.6 | Novel Excipients | 71 | 3.2.P.5 | Control of Drug Product | 72 | 3.2.P.5.1 | Specification(s) | 72 | 3.2.P.5.2 | Analytical Procedures | 73 | 3.2.P.5.3 | Validation of Analytical Procedures | 77 | 3.2.P.5.4 | Batch Analyses | 89 | 3.2.P.5.5 | Characterization of Impurities | 96 | 3.2.P.5.6 | Justification of Specification(s) | 98 | 3.2.P.6 | Reference Standards or Materials | 100 | 3.2.P.7 | Container Closure System | 105 | 3.2.P.8 | Stability | 112 | 3.2.P.8.1 | Stability
CEFTEN (CEFTIBUTEN CAPSULES 400 MG)
MODULE 3
QUALITY
3.1 MODULE 3 TABLE OF CONTENT Sr. No. | Contents | Page No. | 3.1 | MODULE 3 TABLE OF CONTENT | 2 | 3.2 | BODY OF DATA | 4 | 3.2.S | Drug Substance | 4 | 3.2.P | Drug Product | 5 | 3.2.P.1 | Description and Composition of the Drug Product | 5 | 3.2.P.2 | Pharmaceutical Development | 6 | 3.2.P.2.1 | Components of the Drug Product | 8 | 3.2.P.2.1.1 | Drug Substance | 8 | 3.2.P.2.1.2 | Excipients | 10 | 3.2.P.2.2 | Drug Product | 11 | 3.2.P.2.2.1 | Formulation Development | 11 | 3.2.P.2.2.2 | Overages | 13 | 3.2.P.2.2.3 | Physicochemical and Biological Properties | 14 | 3.2.P.2.3 | Manufacturing Process Development | 16 | 3.2.P.2.4 | Container Closure System | 18 | 3.2.P.2.5 | Microbiological Attributes | 19 | 3.2.P.2.6 | Compatibility | 20 | 3.2.P.3 | Manufacture | 21 | 3.2.P.3.1 | Manufacturer(s) | 21 | 3.2.P.3.2 | Batch Formula | 23 | 3.2.P.3.3 | Description of Manufacturing Process and Process Controls | 24 | 3.2.P.3.4 | Controls of Critical Steps and Intermediates | 29 | 3.2.P.3.5 | Process Validation and/or Evaluation | 30 | 3.2.P.4 | Control of Excipients | 42 | 3.2.P.4.1 | Specifications | 43 | 3.2.P.4.2 | Analytical Procedures | 51 | 3.2.P.4.3 | Validation of Analytical Procedures | 68 | 3.2.P.4.4 | Justification of Specifications | 69 | 3.2.P.4.5 | Excipients of Human or Animal Origin | 70 | 3.2.P.4.6 | Novel Excipients | 71 | 3.2.P.5 | Control of Drug Product | 72 | 3.2.P.5.1 | Specification(s) | 72 | 3.2.P.5.2 | Analytical Procedures | 73 | 3.2.P.5.3 | Validation of Analytical Procedures | 77 | 3.2.P.5.4 | Batch Analyses | 89 | 3.2.P.5.5 | Characterization of Impurities | 96 | 3.2.P.5.6 | Justification of Specification(s) | 98 | 3.2.P.6 | Reference Standards or Materials | 100 | 3.2.P.7 | Container Closure System | 105 | 3.2.P.8 | Stability | 112 | 3.2.P.8.1 | Stability
References: 1. The Merk Index Fourteenth Edition. 2. British Pharmacopoeia . 3. United State Pharmacopoeia 4. ICH Guideline. 5. Martindale.