Table 4.

Comparison of the most common API and FPP deficiencies from other agencies [27, 28]

Active pharmaceutical ingredient (API)
MCAZ	SAHPRA	TFMDA	EDQM	WHOPQTm
3.2. S.4.1	3.2. S.3.1	3.2. S.2.2	3.2. S.2.3	3.2.S.2.3
3.2. S.2.2	3.2.S.1 & 3	3.2. S.2.3	3.2. S.3.2	3.2.S.3.2
3.2. S.7	3.2.S.4.1 & 3	3.2. S.4.1	3.2. S.2.2	3.2.S.2.3
3.2. S.5	3.2.S.7.1 &3	3.2. S.4.3	3.2. S.2.4	3.2.S.2.4
3.2.S.1&3	3.2. S.2.2	3.2. S.7	3.2. S.4.4	3.2.S.4.1 & 5

Finished pharmaceutical product (FPP)
MCAZ	SAHPRA	TFMDA	EMA	WHOPQTm
3.2. P.5.1	3.2.P.5.1	3.2. P.5.1	3.2. P.5	3.2. P.3
3.2. P.8.3	3.2.P. 3.3	3.2. P.5.3	3.2. P.3	3.2. P.4
3.2. P.2	3.2. P.1	3.2. P.3.3	3.2. P.2	3.2. P.5
3.2. P.3.3	3.2.P.8/3	3.2. P.3.5	3.2. P.8	3.2. P.8
3.2. P.3.5	3.2. P.7	3.2. P.6	3.2. P.4	3.2. P.7

Modules: 3.2.S.1 general properties of the API, 3.2.S.2 manufacture, 3.2.S.2.2 description of manufacturing process and process controls, 3.2.S.2.3 control of materials, 3.2.S.2.4 controls of critical steps and intermediates, 3.2.S.3 characterization, 3.2.S.3.2 impurities, 3.2.S.4 control of the API, 3.2.S.4.1 specifications, 3.2.S.4.4 batch analysis, 3.2.S.5 reference materials, 3.2.S.7 Container closure system, 3.2.S.7 stability, Modules: 3.2.P.1 Composition and Description, 3.2.P.2 Pharmaceutical Development, 3.2.P.2.2 Pharmaceutical Development, 3.2.P.3.3 Description of the Manufacturing Process, 3.2.P.3.5 Process Validation or Evaluation, 3.2.P.4 Control of the IPIs, 3.2.P.5 Control of FPP, 3.2.P.5.1 Specifications, 3.2.P.7 Container Closure System, 3.2.P.8 Stability Data