Good Manufacturing Practice (GMP) describes a set of principles and procedures that, when followed, ensure that medicines and related substances are of high quality, safety and efficacy. SAHPRA is a participating authority of the Pharmaceutical Inspection Cooperation Scheme (jointly known as PIC/S).
PIC/S aims to develop international standards between countries and pharmaceutical inspection authorities, to provide harmonised and constructive co-operation in the field of GMP. PIC/S affiliation is subject to initial and periodic assessment of the participating authority to ensure that it has equivalent
legislation, regulatory and enforcement procedures and inspection capacity.

According to the South African Good Manufacturing Practice Guidelines, Section 22C(1)(b) of the Medicines and Related Substances Act 1965 (Act 101 of 1965) specifies that manufacturers, importers, exporters, wholesalers and distributers of medicines and related substances must hold a license. Section 35, Regulation 23, of the Act specifies that to hold a license there must be the ability to comply with good manufacturing, wholesaling, or distribution practices as determined by the Authority. This allows for the Authority to determine manufacturing practices and the relevant code of GMP to be applied by manufacturers.

To be able to grow medicinal Cannabis in South Africa, your facility must be GMP certified, so that you may apply for a license with the South African Health Professionals Regulatory Association (SAHPRA).

The GMP certification entails the design and operationalization of a Quality Management System that addresses the following aspects:

  • Quality Assurance
  • Legal Compliance
  • Cultivation
  • Facility & Product Handling
  • Maintenance
  • Security
  • Inventory Management

Cradlestoned Quality Solutions is well-versed with the requirements from SAHPRA in order to become a licensed facility. Our invaluable experience in Quality Management Systems means this becomes a strategic and methodical process, informed by actual experience and authority.