Investigation of the effects of temperature and humidity on yields of a complementary medicine product under regulatory stability conditions

Abstract

Background: The South African Health Products Regulatory Authority (SAHPRA) mandated that all complementary and alternative medicines (CAM) that were marketed and sold in the South African market be registered with the regulatory authority (RA) or have a submission for registration under review with the RA by June 2021, staring with submissions for registration from February 2020(1). The deadline was extended to February 2022. In order to apply for registration of the CAM and continue marketing the product within the South African market, stability data of the finished pharmaceutical product (FPP) was required (2). The environmental storage conditions for which stability data must be generated before registration was stipulated as 25°C ± 2°C/60% RH ± 5% RH or 30°C ± 2°C/65% RH ± 5% RH for 6 months and 40°C ± 2°C/75% RH ± 5% RH for 6 months. Product X is a CAM product that has been manufactured at a South African local pharmaceutical manufacturing company since2020 and sold in the South African market for more than 3 years. The product uses herbal material encapsulated in a hard glean capsule (HGC) to deliver its effects. The batch manufacturing records (BMRs) required the recording of the environmental manufacturing temperatures (TME) and relative humidity percentage (RH %) at theme of manufacture of Product X. The percentage yield of capsules manufactured was also calculated and recorded to ensure quality control of the product during manufacture.