SAHPRA# | TFDA | USFDA* | EMA | WHOPQTm |
|---|
3.2.P.5.1 | 3.2.P.5.1 | 3.2.P.3.3 | 3.2.P.5 | 3.2.P.3 |
3.2.P.3.3 | 3.2.P.5.3 | 3.2.P.5.1 | 3.2.P.3 | 3.2.P.4 |
3.2.P.1 | 3.2.P.3.3 | 3.2.P.8 | 3.2.P.2 | 3.2.P.5 |
3.2.P.8.1/3 | 3.2.P.3.4 | 3.2.P.2.2 | 3.2.P.8 | 3.2.P.8 |
3.2.P.7 | 3.2.P.6 | 3.2.P.4 | 3.2.P.4 | 3.2.P.7 |
- *USFDA did not report on the deficiency quantitatively
- #Sequence included is for non-sterile products, the sequence is different for sterile products. Modules: 3.2.P.1 Composition and Description, 3.2.P.2 Pharmaceutical Development, 3.2.P.3.3 Description of the Manufacturing Process, 3.2.P.3.5 Process Validation or Evaluation, 3.2.P.8 Stability Data, 3.2.P.2.2 Pharmaceutical Development, 3.2.P.5.1 Specifications, 3.2.P.4 Control of the IPIs, 3.2.P.7 Container Closure System (see Table 2 for further descriptions)
