Manufacturing is defined in the General Regulations published in terms of the Medicines Act as all operations including purchasing of material, processing, production, packaging, releasing, storage and shipment of medicines and related substances in accordance with quality assurance and related controls.

Manufacturing must be performed in accordance with the Medicines Act and in a manner that will ensure compliance with Good Manufacturing Practice (GMP), as described in the Guidance Document: Good Manufacturing Practice for Medicine in South Africa (GN R7659 of 2 May 2003), published by the MCC, as well as the relevant provisions of the Pharmacy Act.