GMP Pathway

Workflow steps

1. GMP Assessment
   Determine which GMP pathway applies. SAHPRA is a PIC/S observer working toward full membership. EU-GMP or PIC/S equivalent required for export to most markets.
2. Domestic or Import/Export?
   Domestic production follows SAHPRA GMP (PIC/S alignment). Export to EU, UK, and other markets requires EU-GMP or PIC/S equivalent.
3. SAHPRA GMP — PIC/S alignment
   SAHPRA GMP is aligned with PIC/S standards. SAHPRA is a PIC/S observer working toward full membership. Suitable for domestic supply and some export markets.
   • SAHPRA GMP-compliant manufacturing facility
   • SAHPRA inspection and certification
   • PIC/S-aligned standards
   • SAHPRA is PIC/S observer — not yet full member
4. EU-GMP or PIC/S Required — For export markets
   EU-GMP or PIC/S equivalent required by destination markets. SA exports to Germany, UK, and Netherlands. EEA authority inspection in SA required for EU-GMP Part I.
   • EU-GMP Part I from EEA authority for EU export
   • Full EU-GMP implementation at site
   • EU QP required for EU batch release
   • PIC/S equivalent accepted by some markets
5. Strategic Note
   Growing export sector: SA exports to Germany, UK, and Netherlands. Climate advantage and low labor costs make SA highly competitive. Many SA producers supply EU-licensed finishers who hold EU-GMP Part I.
   • Supplying EU-licensed finisher is common pathway
   • EU finisher takes GMP Part I responsibility
   • SA site holds SAHPRA GMP + GACP
6. GMP Pathway Defined ✓
   GMP pathway identified for target market. Proceed with export authorization or import permit applications.