Chemistry, Manufacturing, and Control of Ophthalmic Formulations - Ocular Pharmacology and Toxicology - page 76

Table 12
(continued)

3.2.S.7 Stability

3.2.S.7.1 Stability Summary and Conclusions

3.2.S.7.2 Post-Approval Stab Protocol and Stability Commitment

3.2.S.7.3 Stability Data

3.2.P DRUG PRODUCT
3.2.P.1 Description and Composition of the Drug Product
3.2.P.2 Pharmaceutical Development
3.2.P.2.0 Pharmaceutical Development—Inclusive
3.2.P.2.1 Components of the Drug Product
3.2.P.2.1.1 Drug Substance
3.2.P.2.1.2 Excipients
3.2.P.2.2 Drug Product
3.2.P.2.2.1 Form Development
3.2.P.2.2.1.1 Overages
3.2.P.2.2.1.2 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.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 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 Control of Excipients—Compendial

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 Control of Excipients

3.2.P.4.5 Excipients of Human or Animal Origin

3.2.P.4.6 Novel Excipients

3.2.P.5 Control of Drug Product

3.2.P.5.1 Specification ( s )

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 System

3.2.P.8 Stability

3.2.P.8.1 Stability Summary and Conclusion

3.2.P.8.2 Post-Approval Stability Protocol and Stability Commitment

3.2.P.8.3 Stability Data

(continued)