Where does GMP begin for cannabis flower?

I followed that question through three EU documents, because each one of them answers one part of it.

Section 12 of the EMA guideline on GACP reads "In some circumstances drying and cutting should be performed according to EudraLex Volume 4 GMP part I or II", and it refers to the table in Annex 7. Under that table Annex 7 has a note. "The GMP classification of the herbal material is dependent upon the use made of it by the manufacturing authorisation holder." So the same flower can be classified as an active substance, an intermediate or a finished product.

Part II of the GMP guide, section 1.2, then tells the manufacturer what to do. "The manufacturer should designate and document the rationale for the point at which production of the active substance begins."

For me it is not enough to state that GMP begins somewhere during post harvest processing. The point has to be defined and written down as evidence that someone can read and challenge.

This is what the official texts tell us today. If the industry creates its own rules and commercial standards, that is another story.

If you need help defining your supply chain strategy in the medical cannabis industry, send me a DM or comment under this post for a free assessment.