GACP regulation for herbal raw materials

The composition of herbal raw materials is the key driver for the quality of everything manufactured from them [1]. This is why the robust supply of herbal raw materials for the production of both, extracts for phyto-pharmaceutical products as well as for natural compounds, which are subsequently used either directly as APIs or even for derivatives, requires rules of the game.

Those have been set up by EUROPAM [2] in 1998 and adapted to the EMA guideline on good agricultural and collection Practice (GACP) for starting materials of herbal origin [3] in 2006. Their compilation led to a price increase due to implementation of QM systems on the farms and additional work because of a rise in documentation. Nevertheless they are an essential part of the overall production process as they intrinsic lead to reliable quality. A meaningful and appropriate elaborated QM system helps economic improvement of processes and quality [4]. Hence, the obligation to work according to the guideline boosts the chance to produce the crop more tailor-made and enables companies to compete in the market with unique products.

References:

[1] Brand, N.; Brückner, T.; Gaedcke, F.; Steinhoff, B. Pharm Ind 71 (2009) 490 – 500

[2] Guidelines for Good Agricultural and Wild Collection Practices for Medicinal and Aromatic Plants (GACP-MAP) EUROPAM, 8^th ed. (2010) http://www.europam.net/documents/gacp/EUROPAM_GACP_MAP_8.0.pdf

[3] HMPC Guideline on Good Agricultural and Collection Practice (GACP) for Starting Materials Of Herbal Origin; EMA (2006) http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003362.pdf

[4] Graf vom Hagen-Plettenberg M, Klier B, Tegtmeier M, Waimer F, Steinhoff B. Z ARZNEI- GEWURZPFLA (2012);17:105 – 108.