Skip to main content

GACP Audit Requirements

Good Agricultural and Collecting Practice (GACP) is applied to the cultivation, collection, and primary processing of herbal substances that are used for the preparation of herbal medicinal products. Relevant GACP guidelines are available, such as e.g. the “Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin” issued by the European Medicines Agency. This guideline should be read in connection with EU GMP Part II for APIs and Annex 7 for manufacture of Herbal Medicinal Products. The manufacturer of medicinal product should ensure that regular audits of the primary producers (cultivators, harvesters, and collectors) are performed.

The GACP audit

Good Agricultural and Collection Practices (GACP) audits are critical for ensuring the quality and safety of herbal medicinal products. The above-mentioned GACP guidelines provide a framework for the proper cultivation, harvesting, and primary processing of herbal materials intended for medicinal use. By adhering to these practices, producers make sure that the plant-based products are consistent in their quality, free from contamination, and sustainably sourced.
During GACP audits, auditors assess whether producers comply with the guidelines, which cover aspects such as site selection, plant material identification, use of pesticides, soil management, and record-keeping. Successful audits are essential for producers to gain credibility and trust in the medicinal and herbal markets. These practices contribute significantly to the safety and efficacy of herbal medicinal products.

blue inspection has experienced auditors who are qualified to audit under intricate conditions and check whether cultivators and wild harvesters work in accordance with the applicable guidelines. Auditing in line with the Good Agricultural and Collecting Practice encompasses not only a quality control system, but also specification and selection of seeds, cultivation, harvesting and the subsequent initial processing steps, to name a few.

This email address is being protected from spambots. You need JavaScript enabled to view it.
This email address is being protected from spambots. You need JavaScript enabled to view it.
© blue inspection GmbH. All rights reserved.