GMP Advisory & Manufacturing Compliance

GMP Advisory & Manufacturing Compliance

GMP compliance is not optional. It's also not straightforward. PPB's GMP guidelines reference ICH Q7, but they don't enforce every line of it—they emphasize what they actually inspect. SAHPRA is more rigorous. NAFDAC varies. We help you build manufacturing systems that pass inspection and don't waste money on practices regulators don't require.

Our GMP work starts with a reality check: a manufacturing site assessment against PPB/SAHPRA requirements, identification of gaps, and a remediation plan. Then we help you execute. That includes quality system documentation (SOPs, batch records, deviation procedures), training program design, environmental monitoring protocols, and supplier qualification. We also prepare you for inspection—we know what PPB inspectors actually look for and how they respond if something is unclear.

If you're building a manufacturing facility from scratch, we advise on site selection, design principles, equipment specification, and compliance staging. We've supported setup of facilities near Namanga (where our own facility is located), giving us practical insight into what works in that region and what doesn't.