Table 2 FPP (3.2.P) sections and subsections for classification of observations
CTD sections and subsections | Content |
|---|---|
3.2.P.1 | Description and Composition |
3.2.P.2 | Pharmaceutical Development |
3.2.P.2.1 | Components of the Pharmaceutical Product |
3.2.P.2.2 | Final Pharmaceutical Product |
3.2.P.2.3 | Manufacturing Process Development |
3.2.P.2.4 | Container Closure System |
3.2.P.2.5 | Microbial Attributes |
3.2.P.2.6 | Compatibility |
3.2.P.3 | Manufacture |
3.2.P.3.1 | Manufacturer(s) |
3.2.P.3.2 | Batch Formula |
3.2.P.3.3 | Description of Manufacturing Process and Process Control |
3.2.P.3.4 | Control of Critical Steps and Intermediates |
3.2.P.3.5 | Process Validation and/or Evaluation |
3.2.P.4 | Control of Inactive Pharmaceutical Ingredients |
3.2.P.4.1 | Specifications |
3.2.P.4.2 | Analytical Procedures |
3.2.P.4.3 | Validation of Analytical Procedures |
3.2.P.4.4 | Justification of Specifications |
3.2.P.4.5 | Excipients of Human Origin |
3.2.P.4.6 | Novel Excipients |
3.2.P.5 | Control of Finished Pharmaceutical Product |
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 Analysis |
3.2.P.5.5 | Characterisation of Impurities |
3.2.P.5.6 | Justification of Specifications |
3.2.P.6 | Reference Standard or Materials |
3.2.P.7 | Container Closure System |
3.2.P.8 | Stability |
3.2.P.8.1 | Stability Summary and Conclusions |
3.2.P.8.2 | Post-approval Stability Protocol and Stability Commitment |
3.2.P.8.3 | Stability Data |