GACP, GPPC & GMP

Urs Kundert
CEO Sales & Business Development

edu: ECA - GMP for HMP's / ECA - Qualification and validation for Cannabis / GDP for API's / GMP for Maintenance

ECA-Member of: Europ. GDP Association, Europ. QP Association, Data Integrity & IT Compliance Group, Validation Group

Les termes "GACP (Kan.GPPC, où le C signifie cannabis)" et "GMP" sont devenus de plus en plus importants dans la culture et la transformation des produits à base de cannabis, en particulier ces dernières années.
Un certain nombre d'harmonisations internationales (ICH, ECA-Found.) et de révisions sont également en cours.
Nous sommes heureux de fournir du matériel d'information ci-dessous pour ceux qui sont intéressés.

GACP

guideline-good-agricultural-collection-practice-gacp-starting-materials-herbal-origin_enguideline-good-agricultural-collection-practice-gacp-starting-materials-herbal-origin_en
traditional-herbal-medicinal-products-revision-3_entraditional-herbal-medicinal-products-revision-3_en
who_gacpwho_gacp

GMP

euGMP Guideline EN Part III

2011_site_master_file_en_0.pdfExplanatory Notes on the preparation of a Site Master File
2013_01_28_template_0.pdfTemplate for the 'written confirmation' for active substances exported to the European Union for medicinal products for human use, in accordance with Article 46b(2)(b) of Directive 2001/83/EC
CELEX_52015XC0321_02__EN_TXT.pdfformalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use
gmp_mah_rp_en_0.pdfGood Manufacturing Practice and Marketing Authorisation Holders
guideline_handling-shipping_investigational-mp_en.pdfresponsibilities of the sponsor with regard to handling and shipping of investigational medicinal products for human use
international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use_en-3.pdfICH guideline Q10 on pharmaceutical quality system
international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human_en.pdfICH guideline Q9 on quality risk management
mra_batch-certificate_05-2011_0.pdfInternationally harmonised requirements for batch certification
template_imp_batch_certification_0.docxBatch Certificate Investigational Medicinal Products Template