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?

Answer:
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?

Answer:
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..

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

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