PIC/S is designed to assist NRAs in strengthening their inspectorates and regulatory standards. PIC/S members achieve this by harmonizing their processes for inspecting quality systems and their good manufacturing practice (GMP) guidelines; promoting networks with regulatory authorities in different nations to develop mutual confidence; exchanging information and practical experience with GMP and related topics; mutually training inspectors; and supporting GMP inspectors.
PIC/S leaders acknowledge that the role of a NRA is to guarantee the quality, safety, and efficacy of medicines made available to the public and that GMPs are the mainstay of quality assurance in pharmaceutical production and control. GMP recommendations and legislation alone do not determine the success of quality assurance. Quality, as a concept, and GMP-compliance by the pharmaceutical industry are also dependent on effective implementation, appropriate enforcement, and a common interpretation and understanding of GMP principles by the appropriate authority's GMP inspectorate team and by the regulated industry.The Medicines Control Council (MCC) of South Africa joined PIC/S in July 2007, becoming the African continent's only PIC/S member. The following section discusses the regulatory body's accession to the international group.
South Africa's quest for membership
South Africa's journey to attain PIC/S membership was not without its share of challenges. Buy-in from all stakeholders, including political leaders, the government, and industry, was essential to allow for a joint strategic approach.
The first requisite to improving the availability of good quality medicines in South Africa was to obtain political support and determination for the harmonization of pharmaceutical GMP requirements with international standards. In addition, industry support for the strengthening of the national regulatory system with regard to GMP promotion had to be obtained. Fortunately, both the government and industry supported MCC's goals, and the council began the application process in 1997.
With regulatory and industry support, MCC researched the country's 1965 Medicines and Related Substances Act 101 to determine what types of amendments needed to be made. The Act provides for the registration of human and veterinary medicines and the establishment of a medicines control council and appropriate committees with the mandate to register medicines based on quality, safety, and efficacy. The council also has the authority to regulate the purchase and sale of medicines by pharmaceutical manufacturers, wholesalers, and the retail sector and to appoint inspectors to enforce the Act.
The MCC team concluded that amendments needed to be made to the Act to require that pharmaceutical companies that manufacture (total or partial), package, label, import, export, distribute, or test any type of medicine obtain a manufacturing license from MCC and that wholesalers or distributors of medicines obtain a wholesaling license from MCC. These amendments were passed in 2003 with the enactment of the Amendment Act.
In addition, the MCC's GMP Inspectorate developed a quality management system to address a suitable code of practice, conflicts of interest, standard operating procedures for inspection activities, and appropriate inspectorate enforcement. This system was established in line with the provisions of the Medicines Act.
MCC also had to ensure that pharmaceutical products available in South Africa meet national and international standards of safety, efficacy, and quality, a harmonized approach to GMP, in line with PIC/S's prescribed requirements. The council worked with the domestic industry to adapt and adopt the PIC/S GMP Guidelines to support their own national regulatory framework. The council gained industry support for the new standards by holding a series of 13 MCC-industry workshops between January 2004 and January 2005.
The next hurdle facing MCC was to increase the capacity of its GMP Inspectorate by strengthening its administrative, structural, and technical elements. MCC also appointed a quality manager to ensure compliance with the newly developed quality system.
The council then tackled industry compliance with the updated GMP requirements. MCC's goal was to advance industry's GMP standards to an acceptable level by using and developing the variety of experiences and technical expertise available throughout the country and by calling in external expertise where needed. An additional MCC-industry workshop was held in February 2006 to discuss and clarify key aspects of the new guidelines. MCC officials found that an open-door policy to advise and guide (rather than consult) was the best approach to take with industry. Two major drug-manufacturing compliance issues requiring changes among industry were the clean-class concept and enforcement of GMP principles by contract acceptors.
Finally, in September 2006, a team of senior inspectors from five PIC/S member authorities assessed MCC and its progress. The assessment team made several observations, to which MCC responded, and in July 2007, South Africa's MCC was granted membership in PIC/S—a first for Africa.
Looking back, it is clear that MCC could not have achieved PIC/S membership without support from industry and other groups. A collaborative effort was critical to meeting common goals. Today, MCC continues to strengthen its regulatory capacities by tapping into the pool of PIC/S expertise. In addition, PIC/S membership has provided South Africa with the opportunity to draw on the technical resources of developed countries and the opportunity to build technical capacity as well as a repository of critical information to keep its medicines safe and effective.
Joey Gouws, PhD, is director of Inspectorate and Law Enforcement at the National Medicines Regulatory Authority for South Africa's Department of Health, [email protected]