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

dc.contributor.authorMoeti, Lerato
dc.contributor.authorLitedu, Madira
dc.contributor.authorJoubert, Jacques
dc.date.accessioned2022-02-03T11:25:17Z
dc.date.available2022-02-03T11:25:17Z
dc.date.issued2022
dc.description.abstractThe 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).en_US
dc.identifier.citationMoeti, L. et al. (2022). Common defciencies found in generic Finished Pharmaceutical Product (FPP) applications submitted for registration to the South African Health Products Regulatory Authority (SAHPRA). Journal of Pharmaceutical Policy and Practice. 15, 6. https://doi.org/10.1186/s40545-021-00398-5en_US
dc.identifier.issn2052-3211
dc.identifier.urihttps://doi.org/10.1186/s40545-021-00398-5
dc.identifier.urihttp://hdl.handle.net/10566/7148
dc.language.isoenen_US
dc.publisherSpringer Natureen_US
dc.subjectFinished Pharmaceutical Product (FPP)en_US
dc.subjectCommon defcienciesen_US
dc.subjectSouth African Health Products Regulatory Authority (SAHPRA)en_US
dc.subjectNon-sterile productsen_US
dc.subjectSterile productsen_US
dc.titleCommon defciencies found in generic Finished Pharmaceutical Product (FPP) applications submitted for registration to the South African Health Products Regulatory Authority (SAHPRA)en_US
dc.typeArticleen_US

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