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
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 (ICH, ECA-Found.) and revisions are also currently in progress.
We are happy to provide information material below for those who are interested.
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 Guidelines Part I
- 2011_intro_en_0.pdfIntroduction
- vol4-chap1_2013-01_en_0.pdfChapter 1 - Pharmaceutical Quality System
- 2014-03_chapter_2_0.pdfChapter 2 - Personnel
- chapter_3_0.pdfChapter 3 - Premise and Equipment
- chapter4_01-2011_en_0.pdfChapter 4 - Documentation
- chapter_5_0.pdfChapter 5 - Production
- 2014-11_vol4_chapter_6_0.pdfChapter 6 - Quality Control
- vol4-chap7_2012-06_en_0.pdfChapter 7 - Outsourced Activities
- 2014-08_gmp_chap8_0.pdfChapter 8 - Complaints and Product Recall
- cap9_en_0.pdfChapter 9 - Self Inspection
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
GPPC
- good-production-practices-guide-for-cannabis-2019-10.pdfgood-production-practices-guide-for-cannabis-2019-10
Biosuisse
- 1032-hilfsstoffliste.pdf1032-hilfsstoffliste
- bio_suisse_richtlinien_2022_de_2.pdfbio_suisse_richtlinien_2022_de_2
Links
GACP GCCP GMP GDP Cannabis Management Software
