Quality of Herbal Medicinal Products - Current EMA/HMPC Q&A Document

On the 20th of October 2010, the European Medicines Agency (EMA) published the document 41500/2010 containing interesting Questions and Answers on quality of herbal medicinal products/traditional herbal medicinal products.

In total, you can read answers to 26 different questions on the following fields:

  • Specification of the finished product
  • Testing
  • Contaminants (Mycotoxins)
  • Microbiological quality
  • Fumigants 
  • Manufacture
  • Quality of water
  • Stability

Stability has been the most asked subject with 12 questions. 

Here are 2 examples:

Question 25:
Is one type of chromatographic fingerprint sufficient for stability testing of the finished product?

Yes, in most cases. If more than one group of constituents is known to contribute to the activity of the active substance, the fingerprints should cover all the groups.

Question 26:
Are stability overages for herbal active substances acceptable?

In general, as the whole herbal substance/preparation is considered as the active substance, stability overages wouldn't be acceptable. However, stability overages would be acceptable for standardized extracts if justified.

You may want to find more - here's the complete Q&A document..

Dr Günter Brendelberger
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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