GACP, GPPC, GDP & GMP
Urs Kundert
CEO Sales & Business Development
ECA Member of
Europ. GMP-Auditor Association
Europ. GDP Association
Europ. QP Association
Data Integrity & IT Compliance Group
Validation Group
edu
GMP Auditor FA1
Responsible Person for GDP
Requirements for Vaporizers for Medical Cannabis
GMP for HMP's
GDP for API's
GMP for Maintenance
Qualification and validation for Cannabis
The terms "GACP (Kan.GPPC, where the C stands for cannabis)" and "GMP" have become increasingly important in the cultivation and processing of cannabis products, especially in recent years.
A number of international harmonizations and revisions are also currently in progress.
We are happy to provide information material below for those who are interested.
Update:
New version of the EMA-GACP guidelines now available for viewing or downloading! (April 2024)
GACP - Good Agricultural and Collection Practice
- EMA_draft-guideline-good-agricultural-collection-practice-gacp-starting-materials-herbal-origin-revision-1_enEMA_draft-guideline-good-agricultural-collection-practice-gacp-starting-materials-herbal-origin-revision-1_en (April 2024)
- 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 - Good Manufacturing Practice
euGMP Guidelines Part II
- 2014-08_gmp_part1_0.pdfeuGMP Part II - Basic requirements for active substances used as starting materials
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
euGMP Guidelines Part IV
- 2017_11_22_guidelines_gmp_for_atmps_0.pdfeuGMP Part IV - Advanced Therapy Medicinal Products
euGMP Annexes
- annex1_en__Manufacture_of_Sterile_Medicinal_Products.pdfannex 1 en - Manufacture of Sterile Medicinal Products
- annex2_en_Manufacture_of_Biological_active_substances_and_Medicinal_Products_for_Human_Use.pdfannex 2 en - Manufacture of Biological active substances and Medicinal Products for Human Use
- annex3_en_Manufacture_of_Radiopharmaceuticals.pdfannex 3 en - Manufacture of Radiopharmaceuticals
- annex4_en_Manufacture_of_Veterinary_Medicinal_Products_other_than_Immunological_Veterinary_Medicinal_Products.pdfannex 4 en - Manufacture of Veterinary Medicinal Products other than Immunological Veterinary Medicinal Products
- annex5_en_Manufacture_of_Immunological_Veterinary_Medicinal_ProductsSearch_for_available_translations_of_the_preceding_link.pdfannex 5 en - Manufacture of Immunological Veterinary Medicinal Products
- annex6_en_Manufacture_of_Medicinal_Gases.pdfannex 6 en - Manufacture of Medicinal Gases
- annex7_en_Manufacture_of_Herbal_Medicinal_ProductsSearch_for_available_translations_of_the_preceding_link.pdfannex 7 en - Manufacture of Herbal Medicinal Products
- annex8_en_Sampling_of_Starting_and_Packaging_MaterialsSearch_for_available_translations_of_the_preceding_link.pdfannex 8 en - Sampling of Starting and Packaging Materials
- annex9_en_Manufacture_of_Liquids__Creams_and_Ointments.pdfannex 9 en - Manufacture of Liquids, Creams and Ointments
- annex10_en_Manufacture_of_Pressurised_Metered_Dose_Aerosol_Preparations_for_InhalationSearch_for_available_translations_of_the_preceding_link.pdfannex 10 en - Manufacture of Pressurised Metered Dose Aerosol Preparations for Inhalation
- annex12_en_Use_of_Ionising_Radiation_in_the_Manufacture_of_Medicinal_ProductsSearch_for_available_translations_of_the_preceding_link.pdfannex 12 en - Use of Ionising Radiation in the Manufacture of Medicinal Products
- annex13_en_Manufacture_of_Investigational_Medicinal_ProductsSearch_for_available_translations_of_the_preceding_link.pdfannex 13 en - Manufacture of Investigational Medicinal Products
- annex14_en_Manufacture_of_Products_derived_from_Human_Blood_or_Human_Plasma4.pdfannex 14 en - Manufacture of Products derived from Human Blood or Human Plasma
- annex15_en_Qualification_and_validation.pdfannex 15 en - Qualification and validation
- annex16_en_Certification_by_a_Qualified_Person_and_Batch_Release.pdfannex 16 en - Certification by a Qualified Person and Batch Release
- annex17_en_Parametric_release.pdfannex 17 en - Real Time Release Testing and Parametric Release
- annex19_en_Reference_and_Retention_Samples.pdfannex 19 en - Reference and Retention Samples
- annex21_en_Importation_of_medicinal_products.pdfannex 21 en - Importation of medicinal products
[Translate to English:] GDP - Good Distribution Practice
- CELEX_GDP_Guidelines_EN_TXT.pdfGDP_Guidelines_EN_TXT.pdf
- CELEX_GDP_Guidelines_DE_TXT.pdfGDP_Guidelines_DE_TXT.pdf
GPPC - Good Producton Practice for Cannabis
- good-production-practices-guide-for-cannabis-2019-10.pdfgood-production-practices-guide-for-cannabis-2019-10
Datenintegrität und Bedeutung von ALCOA+ / Dataintegrity and meaning of ALCOA+
WHO - The International Pharmacopoeia (Ph. Int.) - Eleventh Edition 2022
Online publication
Link: The International Pharmacopoeia (Ph. Int.) - Eleventh Edition
Biosuisse
- 1032-hilfsstoffliste.pdf1032-hilfsstoffliste
- bio_suisse_richtlinien_2022_de_2.pdfbio_suisse_richtlinien_2022_de_2
Links
Topics
GACP GCCP GMP GDP Cannabis Management Software
