Final Revised GACP Guideline Published

Following the draft guideline published last year, the EMA's HMPC adopted the final revised Guideline on good agricultural and collection practice (GACP) of starting materials of herbal origin.

Background and Key Updates

The GACP guideline came into effect in August 2006 and it was intended to provide guidance to ensure appropriate and consistent quality of herbal substances and preparations. The recommendations in the guideline apply to all involved supply chain actors, i.e. growers, harvesters, collectors, producers, traders, and processors of medicinal plants and herbal substances. Thus, they each should comply with the reqirements, document all relevant activities in batch documentation and demand that their partners do likewise.

The revision updates the document to current standards taking into account advances over the last 10 years, as for instance, the increased development of indoor growing technologies. It also covers legal interpretations published during this period, e.g. taking into account Annex 7 to the EU GMP Guidelines ("Manufacture of Herbal Medicinal Products") issued in 2009 and on the distinction between GMP and GACP. "The operations that should fall under the scope of GACP, GMP part II (for APIs) or GMP part I (for medicinal products) depend on the application of the finished medicinal product. In general, the closer the preparation is to the final product, the stricter the requirements are."

As expected, additional provisions for indoor cultivation are outlined in Annex 1. Amongst others, for indoor cultivation the following applies:

• Any critical quality attributes and critical process parameters should be identified.
• Appropriate in-process acceptance criteria and controls should be established.
• The cultivation process should be standardised in order to ensure reproducible results.
• Qualification of critical equipment and ancillary systems should be completed.

For more information please see the final revised Guideline on good agricultural and collection practice (GACP) of starting materials of herbal origin together with the Overview of comments received on the draft guideline.