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Inspectorate and Law Enforcement

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About Inspectorate

Licences issued (manufacturing/import etc.)

S.A. Good Manufacturing Practices Guidelines (GMP)

Category List(s)

About Inspectorate

Licences issued (manufacturing/import etc.)

20.14_Licences issued to manufacture, import, export, act as wholesaler or distributor_Mar15_v1(PDF)

S.A. Good Manufacturing Practices Guidelines (GMP)

16.01_Licence_to_manufacture_Feb04_v1 – Licence Application to Manufacture, Import or Export Medicine (Zip)

16.02_Licence_to_act_as_wholesaler (Zip 44kb)

4.01_Updated guide to good manufacturing practice for medicines in South Africa-Jun10_v5 (Zip 255kb)

4.02_Good wholesaling practice for wholesalers, distributors and bonded warehouses-Jun03_v1 (Zip 31kb)

4.03_Aerosol manufacturing -Jun03_v1(Zip 27kb)

4.04_Isolator Technology-Jun03_v1 (Zip 28kb)

4.05_Cephalosporin manufacturing-Jun03_v1 (Zip 28kb)

4.06_Penicillin manufacturing-Jun03_v1 (Zip 29kb)

4.07_Radiopharmaceutical manufacturing (Zip 30kb)

4.08 Guideline for preparation of Site Master File Jun03_v2(PDF)

4.09_Guidelines on inspections involving the GMP inspectors (MS-Word 88kb)

GCP_second_edition(pdf)