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1960 Nobel Laureate

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Basketball Coach

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- Anonymous

 

 

 

 

 

The following is a list of all eCTD template sections for Drug Substance and Drug Product (Module 3 Quality).  General content information is provided in each section as guide along with references to relevant ICH guidance's.  For Phase 1-3 specific required content see CMC Phase 1-3 Guidances.

3.2.S. Drug Substance

3.2.S.1.1 GENERAL INFORMATION (Nomenclature)

3.2.S.1.2 GENERAL INFORMATION (Structure)

3.2.S.1.3 GENERAL INFORMATION (General Properties)

3.2.S.2.1 MANUFACTURE (Manufacturers)

3.2.S.2.2 MANUFACTURE (Description of Manufacturing and Manufacturing Controls)

3.2.S.2.3 MANUFACTURE (Control of Materials)

3.2.S.2.4 MANUFACTURE (Control of Critical Steps and Intermediates)

3.2.S.2.5 MANUFACTURE (Process Validation and-or Evaluation)

3.2.S.3.1 CHARACTERIZATION (Elucidation of Structure and other Characteristics)

3.2.S.3.2 CHARACTERIZATION (Impurities)

3.2.S.4.1 CONTROL OF DRUG SUBSTANCE (Specifications)

3.2.S.4.2 CONTROL OF DRUG SUBSTANCE (Analytical Procedures)

3.2.S.4.3 CONTROL OF DRUG SUBSTANCE (Validation of Analytical Procedures)

3.2.S.4.4 CONTROL OF DRUG SUBSTANCE (Batch Analyses)

3.2.S.4.5 CONTROL OF DRUG SUBSTANCE (Justification of Specification)

3.2.S.5 REFERENCE STANDARDS

3.2.S.6 CONTAINER CLOSURE

3.2.S.7.1 STABILITY (Summary and Conclusions)

3.2.S.7.2 STABILITY (Post Approval Stability Protocol and Stability Commitment)

3.2.S.7.3 STABILITY (Stability Data)

3.2.P. Drug Product 

3.2.P.1 DESCRIPTION AND COMPOSITION OF DRUG PRODUCT

3.2.P.2.1 COMPONENTS OF THE DRUG PRODUCT (Drug Substance, Excipients)

3.2.P.2.2 DRUG PRODUCT (Formulation Development, Overages, Physiochemical and Biological Properties)

3.2.P.2.3 MANUFACTURING PROCESS DEVELOPMENT

3.2.P.2.4 CONTAINER CLOSURE SYSTEM

3.2.P.2.5 MICROBIOLOGICAL ATTRIBUTES

3.2.P.2.6 COMPATIBILITY

3.2.P.3.1 MANUFACTURERS

3.2.P.3.2 BATCH FORMULA

3.2.P.3.3 DESCRIPTION OF MANUFACTURING PROCESS AND PROCESS CONTROLS

3.2.P.3.4 CONTROLS OF CRITICAL STEPS AND INTERMEDIATES

3.2.P.3.5 PROCESS VALIDATION AND-OR EVALUATION

3.2.P.4.1 CONTROL OF EXCIPIENTS (Specifications)

3.2.P.4.2 CONTROL OF EXCIPIENTS (Analytical Procedures)

3.2.P.4.3 CONTROL OF EXCIPIENTS (Validation of Analytical Procedures)

3.2.P.4.4 CONTROL OF EXCIPIENTS (Justification of Specifications)

3.2.P.4.5 CONTROL OF EXCIPIENTS (Excipients of Human or Animal Origin)

3.2.P.4.6 CONTROL OF EXCIPIENTS (Novel Excipients)

3.2.P.5.1 SPECIFICATIONS

3.2.P.5.2 ANALYTICAL PROCEDURES

3.2.P.5.3 VALIDATION OF ANALYTICAL PROCEDURES

3.2.P.5.4 BATCH ANALYSES

3.2.P.5.5 CHARACTERIZATION OF IMPURITIES

3.2.P.5.6 JUSTIFICATION OF SPECIFICATIONS

3.2.P.6 REFERENCE STANDARDS OR MATERIALS

3.2.P.7 CONTAINER CLOSURE

3.2.P.8.1 STABILITY SUMMARY AND CONCLUSIONS

3.2.P.8.2 POSTAPPROVAL STABILITY PROTOCOL AND STABILITY COMMITMENT

3.2.P.8.3 STABILITY DATA

 

3.2.A Appendices 

3.2.A.1 FACILITIES AND EQUIPMENT

3.2.A.2 ADVENTITIOUS AGENTS SAFETY EVALUATION

3.2.A.3 NOVEL EXCIPIENTS

 

3.2.R Regional  

3.2.R.1 REGIONAL INFORMATION

3.2.R.2 METHODS VALIDATION PACKAGE

 

2.3 Example Quality Overall Summery 

Example MK Overall Quality Summery

 

 

 

 
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