Regulatory requirements for Manufacturing and Packing

Pharmaceutical manufacturing (including all nutritional supplements) is now regulated and enforced by SAHPRA. SAHPRA replaces the Medicines Control Council (MCC). SAHPRA is responsible for monitoring, evaluation, regulation, investigation, inspection, registration and control of medicines, scheduled substances, clinical trials, medical devices and related matters in the public interest.

Previously unregulated products including slimming products, sport supplements, health and wellness products, nutraceuticals, as well as vitamins and minerals, have now been included and are now defined as medicines and must be registered and must be manufactured by a licensed manufacturer.

Failure to comply will lead to severe penalties as well as financial losses as all retailers are aligning themselves with new regulations and are removing products that do not conform to the new regulations. Contact us.

Accreditation

License to manufacture medicines:

Calpharm received a renewed License to manufacture medicines, after its latest accreditation inspection by the South Africa Medicines Control Council (SAHPRA).

 

Certificate of compliance to current good manufacturing practice (CGMP certificate):

Calpharm was issued a renewed Certificate of Good Manufacturing Practice, following its recent accreditation inspection by the South African Medicines Control Council (SAHPRA).

 

 

Certificate of compliance to current good manufacturing practice (CGMP certificate):

Calpharm was issued a renewed Certificate of Good Manufacturing Practice, following its recent accreditation inspection by the South African Medicines Control Council (SAHPRA).