How to Demonstrate GACP-Compliance?

The requirement for a written confirmation of Good Agricultural and Collection Practice (GACP) compliance is contained in the draft HMPC Guidance Document of the EMA "Quality of Herbal Medicinal Products" (Draft version 3, June 2018). However, it is already common practice for regulatory authorities to require the submission of a GACP confirmation.

GMP inspectors may also want to see this confirmation of compliance for suppliers of herbal starting materials during inspections of herbal medicinal product (HMP) manufacturers. The requirement for GACP compliance for herbal starting materials (for certain initial manufacturing steps, such as cultivation and harvesting, sometimes also cutting + drying etc.; i.e. steps that take place in the field) can be found, among others, in the EU GMP Guidelines Annex 7 "Manufacture of Herbal Medicinal Products".

How can GACP compliance be demonstrated?

Often the herbal raw material for the use in HMPs is purchased externally and is not produced by the company itself. Therefore, the question about the responsibility for issuing the GACP confirmation arises.

The guideline draft of the EMA states the following: 

"A written GACP declaration for the herbal substance should be provided by the manufacturer of the active substance or the HMP, as appropriate."  (HMP= Herbal medicinal product)

According to this, it may be stipulated in a bilateral Quality Assurance Agreement following supplier qualification (e.g. after an audit) that the qualified supplier responsible for the GACP-compliant production of the herbal raw material provides the GACP confirmation for the corresponding material. Challenges are certainly the different stages within (global) supply chains (grower, trader, supplier, etc.).

The second question is how the GACP declaration can look like and what information it contains. An example for the GACP confirmation can be found in Appendix 2 of the EMA Guideline on the use of the CTD format in the preparation of a registration application for traditional herbal medicinal products. Whether the example is equivalent to the above mentioned "written GACP declaration" has still to be clarified.

For further information please visit the EMA's website Quality of herbal medicinal products/traditional herbal medicinal products.

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