EMA: Draft Revision of GACP Guideline Published
On 18 April, the EMA launched a new draft version of the Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin.
This update brings the document up to date with current standards, incorporates the increased development of indoor growing technologies and also covers best practice and legal interpretations published over the last 10 years.
Notable enhancements include the addition of sections such as "Scope" and "Definitions", as well as references to EU GMP Guide Part I (for medicinal products), Part II (for APIs) and Annex 7 (Manufacture of Herbal Medicinal Products).
In line with guidance from other standards such as EU GMP Guide Annex 7, the stringency of the requirements increases as the preparation approaches its final form.
Almost all sections have been enriched and supplemented with pertinent information to enhance understanding of the GACP requirements.
The public consultation will run until 15 July 2024.
Source:
Meet the GMP Compliance Adviser
The GMP Compliance Adviser is the world's largest knowledge portal for quality management in the pharma business.
The demo access is non-binding and ends automatically.
You may also be interested in the following articles:
