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 |
32S231 | Raw Material Specification |
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 |