Unlike conventional pharmaceutical products, which are usually produced from synthetic materials by means of reproducible manufacturing techniques and procedures, herbal medicinal products (HMPs), including cannabis-based products for medicinal use (CBPMs), are prepared from materials of herbal origin, which are often obtained from varied geographical and/or commercial sources. In addition, due to the often unknown nature of the active(s) and the complexity of the phytochemical constituents, there may be high batch variability and poor quality. As a result, it may not always be possible to ascertain the conditions to which they may have been subjected. In addition, they may vary in composition and properties. Furthermore, the procedures and techniques used in the manufacture and quality control of herbal medicines are often substantially different from those employed for conventional pharmaceutical products. The quality may be affected by cultivation conditions, pests and pesticides and primary processing, among many other factors. For this reason, understanding quality management systems (including GACP, cGMP and EU-GMP), CTD compilation and the regulatory aspects of manufacturing, formulation and registration of these products is key to success in the market place.

The course introduces participants to the theory and practice of manufacturing and registering herbal medicinal products (HMPs), including cannabis-based products for medicinal use (CBPMs) in Southern Africa.

Delegates (without basic pharmacy training) will be introduced to relevant industrial pharmacy theory and practice to be gain a greater understanding / appreciation of the industry and medicine governance. Delegates will gain a basic understanding to enable them to compile and file registration dossiers (in CTD format) correctly which will lead to shorter turn-around times for registration of their products.