blue – ISO 17020 (type A) accredited inspection body for API GMP audits

GACP audits

Good Agricultural and Collecting Practice (GACP) isapplied to cultivation and harvesting of plants and plant exudates, which are used as active ingredients and/or starting materials for the manufacture of active pharmaceutical ingredients. GACP principles also apply to the initial processing steps such as the washing, drying, comminution and initial extraction of medicinal plants.

Good Agricultural and Collecting Practice (GACP)

Manufacturers and marketing authorisation holders of finished medicinal products are required to ensure that the suppliers or producers of these starting materials work in accordance with the GACP. blue inspection body GmbH has experienced auditors who are qualified to work under intricate conditions and check whether cultivators and wild harvesters work in accordance with the various guidelines such as WHO-GACP, EMEA/HMPC-GACP and Annex 7 of the EU-GMP Guide Part 1. Auditing in line with the Good Agricultural and Collecting Practice – for example of n – encompasses not only a quality control system, but also specification and selection of seeds, cultivation, harvesting and the subsequent initial processing steps, to name but a few.

Contact

blue inspection body GmbH
Hafenweg 18-20
48155 Muenster, Germany
Phone: +49 251 62562040

contactNOSPAM@blue-inspection.com
chinaNOSPAM@blue-inspection.com
indiaNOSPAM@blue-inspection.com

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