Fig. 2

The distribution of all deficiencies found in the 3.2.P sections and subsections for non-sterile applications submitted to SAHPRA. Modules: 3.2.P.1 Description and Composition, 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.3.3 Description of the Manufacturing Process, 3.2.P.3.4 Control of Critical Steps and Intermediates, 3.2.P.3.5 Process Validation and/or Evaluation, 3.2.P.4.1 Specifications of IPIs, 3.2.P.4.3 Validation of Analytical Procedures of IPIs, 3.2.P.5.1 Specifications of the FPP, 3.2.P.5.3 Validation of Analytical Procedures of FPP, 3.2.P.5.4 Batch Analysis of the FPP, 3.2.P.5.6 Justification of Specifications, 3.2.P.6 Reference Materials, 3.2.P.7 Container Closure System, 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