EMA: GMP requirements for herbal extracts during early manufacturing steps
EMA published the document "GMP requirements applicable to the early manufacturing steps for comminuted plants and herbal extracts used as active substances" in February 2021.
It clarifies details of GMP requirements that must be met when using non-transgenic comminuted plants and herbal extracts as active substances.
As long as the title of the document is, however, as short is the statement. Primarily, it references the applicable documents:
- The EU GMP Guideline Part II and additionally also the EU GMP Annex 7 apply.
- For herbal active ingredients, which are themselves the finished product, there will be a Q&A on finished products.
- Transgenic plants are treated separately and are covered in EU GMP Annex 2.
Source:
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