Mishonga provides the complete GMP compliance service stack — from facility design and SOP development through inspection preparation, validation, QP certification, and ongoing compliance management.
01
GMP site design & setup
Facility design review, material flow mapping, HVAC and cleanroom specification, equipment selection, and SOP development — from concept through SAHPRA pre-approval inspection.
Site designCleanroomHVACSOPsPre-approval
02
SAHPRA inspection preparation
Mock inspections, gap analyses against PIC/S guidelines, corrective action plans, and inspection day readiness — for routine surveillance, pre-approval, and for-cause inspections.
Mock inspectionPIC/SGap analysisCAPASurveillance
03
QA/QC system development
Quality Management System design — SOPs, batch records, deviation and change control, OOS procedures, and Annual Product Quality Reviews aligned to SAHPRA and international standards.
QMSChange controlOOSAPQRSOPs
04
Validation & qualification
Equipment qualification (IQ/OQ/PQ), process validation, cleaning validation, computer system validation, and analytical method validation — fully documented and SAHPRA-ready.
IQ/OQ/PQProcess val.CSVMethod val.Cleaning val.
05
Qualified person (QP) services
QP certification and batch release services for pharmaceutical and cannabis manufacturing — standing QP or project-based for product launches and site registrations.
QPBatch releaseCertificationStanding QP
06
GxP training programmes
Custom GMP, GDP, GLP, GCP, and GACP training — designed for your team, your regulatory environment, your products. On-site, virtual, or hybrid with assessment and certification.
GMP trainingGDPGACPGLPCustom