Revised GACP Guideline

Recommendation

5/6 June 2024

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Following the concept paper for updating the GACP guideline, the revised Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin has now been published. The document is open for comments until 15 July 2024.

Background

The original guideline was published in February 2006. The update is proposed to ensure that the guideline reflects the current state of the art and practical experience. Since the publication of EU GMP Annex 7 (Manufacture of Herbal Medicinal Products (HMPs)) in September 2009, a number of questions have been raised regarding the applicability of GACP and EU GMP Annex 7, which is why the update was necessary (e.g. also with regard to 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.

The revised document also considers advances over the last years, such as the increased development of indoor cultivation technologies, and also covers best practice and legal interpretations. For indoor cultivation (and greenhouse, if applicable) the agronomic conditions and all materials used during cultivation should be fully documented.

Primary Processing

According to the guideline, primary processing may include

• Washing & Cutting 
• Microbial Decontamination
• Freezing
• Distillation
• Primary & Secondary Drying

All these processes must conform to the competent authority regulations and should be carried out as soon as possible after harvesting. In some circumstances drying and cutting should be performed according to EU GMP Part I or II (see also GMP Requirements for Herbal Substances Used as APIs). In exceptional circumstances some of these steps, like expression and distillation, may be performed in the field (only if it is necessary for these activities to be an integral part of harvesting in order to maintain the quality of the product within the approved specification). In case of distillation in the field, this can be performed at a small plant in the field, which should be audited by the finished HMP manufacturer and validated according to EU GMP principles, and may be subject to inspections by Regulatory Authorities to assess GMP compliance.

Drying

Drying directly on the ground or under direct exposure to the sunlight (in case of natural open-air drying) should be avoided unless specifically required. Attempts must be made to achieve uniform drying of the medicinal plant / herbal drug and thus avoid mould formation and to maintain quality. The drying conditions such as maximum temperature, duration and air circulation must be selected taking into consideration the medicinal plant part to be dried (e.g., root, leaf or flower), and the nature of its active constituent, such as essential oils. Individual conditions must be recorded in detail. In case of artificial drying, gas or electrical ovens should be considered, and the use of wood and petrol ovens minimised, to reduce to possible contamination with polycyclic aromatic hydrocarbons (PAHs).

For more information please see the draft Guideline on good agricultural and collection practice (GACP) of starting materials of herbal origin.