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

Abstract

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.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).