Table 4.

South Africa – The road to Pharmaceutical Inspection Cooperation / Scheme (PIC/S) membership

The South African Health Products Regulatory Authority (SAHPRA), formerly the Medicines Control Council, was invited to join PIC/S in July 2007 – a first for an African country. PIC/S support to NRAs focuses on strengthening their inspectorates by harmonizing good manufacturing practices (GMP) standards and processes for inspection of quality systems, promoting networks and information exchange with other NRAs, and supporting training and capacity building of GMP inspectors. South Africa’s process for PIC/S membership began with application in 1997. A key step in enabling this process was ensuring buy-in and support of all stakeholders, including government and industry. Legislative amendments to the Medicines Act were passed in 2003 to further strengthen licensing arrangements for the manufacturing, import, export, wholesaling, and distribution of medicines. During the application process, the NRA reviewed its existing procedures to identify areas of improvement. The NRA designed and implemented a quality management system that incorporated a quality manual, technical guidelines, and standard operating procedures for all inspection activities, highlighting confidentiality, code of conduct, ethics, and conflict of interest. Improving the capacity of the inspectorate also focused on strengthening administrative, structural, and technical components. Through a series of workshops held between 2004 and 2006, local industry was engaged to adopt the new PIC/S GMP guidelines and ensure their effective implementation, compliance, and enforcement. This process was supported by local technical experts as well as experts from PIC/S member countries to ensure a common interpretation and understanding of the technical principles by both inspectors and industry. Removing barriers to effective communication and encouraging transparency and feedback were key to ensuring the support and compliance of industry stakeholders. In September 2006, PIC/S inspectors assessed the NRA’s progress and made several observations, which were addressed, resulting in admission the following year as PIC/S′ 31st Participating Authority. SAHPRA continues to strengthen its regulatory capacity by tapping into the pool of PIC/S expertise. PIC/S membership has provided opportunities for networking with counterpart NRAs; promoting quality systems and participating in Joint Visit Programmes, Expert Circles, subcommittees, and working groups.