Thanks to a company subdivision, which focusses exclusively on the supply of raw materials, and which is licensed in terms of section 22C by SAHPRA (previously the Medicines Control Council) to import or export medicines or scheduled substances, Contego NutriPharm is in a position to supply raw materials to its customers. We are able to provide the following industries with raw material supply and stock holding, where relevant:
- Nutritionals
- Pharmaceuticals
- Veterinary Products
- Cosmetics
SAHPRA, upon issuing a licence and/or reviewing a licence holder, will review the following aspects and conditions:
- The manufacturer, importer or exporter of a medicine applying for a licence must be registered with the Department of Health relating to the ownership of the manufacturer, importer or exporter.
- The manufacturer, importer or exporter of a medicine applying for a licence must be registered with SAHPRA relating to the Best Manufacturing Practices entertained at the manufacturer, importer or exporter.
- The review will address Best Manufacturing Practices.
In order to comply with the above aspects and conditions the following should be covered and implemented:
- The manufacturer, importer or exporter of a medicine applying for a licence must be registered with the Department of Health relating to the ownership of the manufacturer, importer or exporter;
- A Quality System addressing all aspects of quality assurance must be in place, covering Contracts (Agreements); Purchasing; Final Product handling, storage; facility installation, servicing, cleanliness; documentation controls and records; international regulatory control; internal and external audits; training; complaint handling; emergency plan and recalls; quality assurance and management review; distribution (transport, delivery, temperature control); counterfeit medicines; theft of product; export documentation (proof of export).
