| Document Number | File Name | Year | Version | Document Type | Download |
|---|---|---|---|---|---|
| How to Respond to a GMP, GWP or GCP Inspection Report | 2019 | 1 | Guideline | Download PDF | |
| 2.04 | Post importation testing guideline | 2021 | 4 | Guideline | Download PDF |
| 4.01 | SA Guide to Good Manufacturing Practice for Medicines | 2019 | 7 | Guideline | Download PDF |
| 4.02 | South African Good Wholesaling Practice for Wholesalers | 2016 | 2 | Guideline | Download PDF |
| 4.03 | Aerosol Manufacturing | 2019 | 1.1 | Guideline | Download PDF |
| 4.04 | Isolator technology | 2019 | 1 | Guideline | Download PDF |
| 4.05 | Cephalosporin manufacture | 2019 | 1 | Guideline | Download PDF |
| 4.06 | Penicillin manufacture | 2019 | 1.1 | Guideline | Download PDF |
| 4.07 | Radiopharmaceutical manufacture | 2019 | 1 | Guideline | Download PDF |
| 4.08 | Site master file | 2019 | 2.1 | Guideline | Download PDF |
| 4.09 | Inspections involving GMP inspectors | 2019 | 1.2 | Guideline | Download PDF |
| 4.10 | Wholesalers to Export Medicinal Products | 2016 | 1.2 | Guideline | Download PDF |
| 4.11 | HOW TO RESPOND TO A GMP,GWP OR GCP INSPECTION REPORT | 2019 | 1.2 | Guideline | Download PDF |
| 4.13 | Guide to Fee Determination and Payments Of GxP and Product-Related Inspections | 2021 | 1 | Guideline | Download PDF |
| 16.01 | Licence to Manufacture, Import or Export | 2019 | 1.1 | Guideline | Download PDF |