|
Code
|
Display
|
|
32S10
|
Substance General Information |
|
32S11
|
Substance Nomenclature |
|
32S12
|
Substance Structure |
|
32S13
|
Substance General Properties |
|
32S20
|
Substance Manufacture |
|
32S21
|
Substance Manufacturers |
|
32S22
|
Substance Description of Manufacturing Process and Process Controls |
|
32S23
|
Substance Control of Materials |
|
32S24
|
Substance Controls of Critical Steps and Intermediates |
|
32S25
|
Substance Process Validation and/or Evaluation |
|
32S26
|
Substance Manufacturing Process Development |
|
32S30
|
Substance Characterization |
|
32S31
|
Substance Elucidation of Structure and other Characteristics |
|
32S32
|
Substance Impurities |
|
32S40
|
Substance Control of Drug Substance |
|
32S41
|
Substance Specification |
|
32S42
|
Substance Analytical Procedures |
|
32S43
|
Substance Validation of Analytical Procedures |
|
32S44
|
Substance Batch Analyses |
|
32S45
|
Substance Justification of Specification |
|
32S50
|
Substance Reference Standards or Materials |
|
32S60
|
Substance Container Closure System |
|
32S70
|
Substance Stability |
|
32S71
|
Substance Stability Summary and Conclusions |
|
32S72
|
Substance Postapproval Stability Protocol and Stability Commitment |
|
32S73
|
Substance Stability Data |
|
32P10
|
Product Description and Composition of the Drug Product |
|
32P11
|
Product Description |
|
32P12
|
Product Composition |
|
32P13
|
Product Container Closure Description |
|
32P20
|
Product Pharmaceutical Development |
|
32P21
|
Product Components of the Drug Product |
|
32P22
|
Product Drug Product |
|
32P23
|
Product Manufacturing Process Development |
|
32P24
|
Product Container Closure System |
|
32P25
|
Product Microbiological Attributes |
|
32P26
|
Product Compatibility |
|
32P30
|
Product Manufacture |
|
32P31
|
Product Manufacturers |
|
32P32
|
Product Batch Formula |
|
32P33
|
Product Description of Manufacturing Process and Process Controls |
|
32P34
|
Product Controls of Critical Steps and Intermediates |
|
32P35
|
Product Process Validation and/or Evaluation |
|
32P40
|
Product Control of Excipients |
|
32P41
|
Excipients Specification |
|
32P42
|
Product Analytical Procedures |
|
32P43
|
Product Validation of Analytical Procedures |
|
32P44
|
Product Justification of Specifications |
|
32P45
|
Product Excipients of Human or Animal Origin |
|
32P46
|
Product Novel Excipients |
|
32P50
|
Product name dosage form |
|
32P51
|
Product Specification |
|
32P52
|
Product Analytical Procedures |
|
32P53
|
Product Validation of Analytical Procedures |
|
32P54
|
Product Batch Analyses |
|
32P55
|
Product Characterization of Impurities |
|
32P56
|
Product Justification of Specifications |
|
32P60
|
Product Reference Standards or Materials |
|
32P70
|
Product Container Closure System |
|
32P80
|
Product Stability |
|
32P81
|
Product Stability Summary and Conclusion |
|
32P82
|
Product Postapproval Stability Protocol and Stability Commitment |
|
32P83
|
Product Stability Data |
|
SP4151
|
Quality Specification |
|
SP4454
|
Batch Analyses |
|
SP7383
|
Stability Data |
|
SP7181
|
Stability Summary and Conclusion |