Table 3.

Distribution of critical deficiencies among refused products

Section of dossier	Critical deficiencies	n (%)	p value
Administrative
Module 1.2	Complete MC8 form	14 (9.3%)	< 0.001
Module 1.2.5.2	Certificate of Pharmaceutical Product	13 (8.7%)	< 0.001
Module 1.6	API manufacturing site GMP compliance	36 (24.0%)	< 0.001
Module 1.6	FPP manufacturing Site GMP compliance	43 (28.7%)	< 0.001
Failure to respond to request for additional data within the stipulated timelines		79 (52.6%)	< 0.001
Quality
Module 3.2.S.1–6	API information (CEP/DMF)	82 (54.7%)	< 0.001
Module 3.2.S.7.1	API Forced degradation Studies	2 (1.3%)	0.067
Module 3.2.S.7.3	API Stability Data	38 (25.3%)	< 0.001
Module 3.2.P.1	Dosage Unit Batch Formulae	6 (4.0%)	< 0.001
Module 3.2.P.2	Pharmaceutical development	47 (31.3%)	< 0.001
Module 3.2.P.4.1	Excipient Specification	7 (4.7%)	< 0.001
Module 3.2.P.5.1	FPP Specifications	64 (42.7%)	< 0.001
Module 3.2.P.5.2	Analytical Procedures	18 (12.0%)	< 0.001
Module 3.2.P.5.3	Analytical method validation	16 (10.7)	< 0.001
Module 3.2.P.3.3	FPP manufacturing Procedure	35 (23.3%)	< 0.001
Module 3.2.P.3.5	Manufacturing Process Validation	30 (20.0%)	< 0.001
Module 3.2.R.1	BMR	31 (20.7%)	< 0.001
Module 3.2.P.8.3	FPP Accelerated Stability Data	30 (20.0)	< 0.001
Module 3.2.P.8.3	FPP Long term stability Data	54 (36.0%)	< 0.001
Safety and efficacy
Module 5	Bioequivalence study	36 (24.0%)	< 0.001
Module 5	Biowaiver applications	19 (12.7%)	< 0.001
Module 5	Summary of clinical studies	8 (5.3%)	< 0.001
Module 4	Non-Clinical data	1	0.259