Common deficiencies found in generic Finished Pharmaceutical Product (FPP) applications submitted for registration to the South African Health Products Regulatory Authority (SAHPRA)

Background: The aim of the study was to investigate the common defciencies observed in the Finished Pharmaceutical Product (FPP) section of generic product applications submitted to SAHPRA. The study was conducted retrospectively over a 7-year period (2011–2017) for products that were fnalised by the Pharmaceutical and Analytical pre-registration Unit. Methods: There were 3148 fnalised products in 2011–2017, 667 of which were sterile while 2089 were non-sterile. In order to attain a representative sample for the study, statistical sampling was conducted. Sample size was obtained using the statistical tables found in literature and confrmed by a sample size calculation with a 95% confdence level. The selection of the products was according to the therapeutic category using the multi-stage sampling method called stratifed-systematic sampling. This resulted in the selection of 325 applications for non-sterile products and 244 applications for sterile products. Subsequently, all the defciencies were collected and categorised according to Common Technical Document (CTD) subsections of the FPP section (3.2.P). Results: A total of 3253 defciencies were collected from 325 non-sterile applications while 2742 defciencies were collected from 244 sterile applications. The most common defciencies in the FPP section for non-sterile products were on the following sections: Specifcations (15%), Description and Composition (14%), Description of the Manufacturing Process (13%), Stability Data (7.6%) and the Container Closure System (7.3%). The defciencies applicable to the sterile products were quantifed and the subsection, Validation and/or Evaluation (18%) has the most defciencies. Comparison of the defciencies with those reported by other agencies such as the USFDA, EMA, TFDA and WHOPQTm are discussed with similarities outlined. Conclusions: The overall top fve most common defciencies observed by SAHPRA were extensively discussed for the generic products.

Background: The aim of the study was to investigate the common defciencies observed in the Finished Pharmaceutical Product (FPP) section of generic product applications submitted to SAHPRA. The study was conducted retrospectively over a 7-year period (2011–2017) for products that were fnalised by the Pharmaceutical and Analytical pre-registration Unit. Methods: There were 3148 fnalised products in 2011–2017, 667 of which were sterile while 2089 were non-sterile. In order to attain a representative sample for the study, statistical sampling was conducted. Sample size was obtained using the statistical tables found in literature and confrmed by a sample size calculation with a 95% confdence level. The selection of the products was according to the therapeutic category using the multi-stage sampling method called stratifed-systematic sampling. This resulted in the selection of 325 applications for non-sterile products and 244 applications for sterile products. Subsequently, all the defciencies were collected and categorised according to Common Technical Document (CTD) subsections of the FPP section (3.2.P). Results: A total of 3253 defciencies were collected from 325 non-sterile applications while 2742 defciencies were collected from 244 sterile applications. The most common defciencies in the FPP section for non-sterile products were on the following sections: Specifcations (15%), Description and Composition (14%), Description of the Manufacturing Process (13%), Stability Data (7.6%) and the Container Closure System (7.3%). The defciencies applicable to the sterile products were quantifed and the subsection, Validation and/or Evaluation (18%) has the most defciencies. Comparison of the defciencies with those reported by other agencies such as the USFDA, EMA, TFDA and WHOPQTm are discussed with similarities outlined. Conclusions: The overall top fve most common defciencies observed by SAHPRA were extensively discussed for the generic products.