GMP for Cannabis – what you need to know 2nd Conference 2019 Im Auftrag der ECA Academy
Heidelberg, Germany
Kurs Nr. 17490
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Speakers
Constantine Emmanouilidi, Epsilon Greenhouses, Greece
Dr Reinhard Kerker, GMP Inspectorate, Germany
Silja du Mont, GDP/GCP Inspectorate, Germany
Dirk Ohlenforst, Bonn, Germany
Dr Andreas Schieweck, GMP Inspectorate LAGuS, Germany
Robert Schwanke, GrowIn, Germany
Judith Steffens, Cannamedical, Germany
Dr Mona Tawab, Zentrallaboratorium Deutscher Apotheker, Germany
Dr Ingrid Walther, Pharma Consulting Walther, Germany
Dr Reinhard Kerker, GMP Inspectorate, Germany
Silja du Mont, GDP/GCP Inspectorate, Germany
Dirk Ohlenforst, Bonn, Germany
Dr Andreas Schieweck, GMP Inspectorate LAGuS, Germany
Robert Schwanke, GrowIn, Germany
Judith Steffens, Cannamedical, Germany
Dr Mona Tawab, Zentrallaboratorium Deutscher Apotheker, Germany
Dr Ingrid Walther, Pharma Consulting Walther, Germany
Objectives
Medical cannabis has been permitted for prescription in Germany since 2017, causing a need for producers supplying pharmacists and physicians with the newly “legalized” drug. But what qualifies as medical grade cannabis? This conference will give you an overview of all relevant regulatory and GMP/GDP requirements and aspects of medical cannabis.
Background
In March 2017, the national German legislature expanded the options for prescribing medical cannabis products by passing a law amending provisions under the Narcotics Law and other regulations. These products, however, must comply with the relevant requirements laid down under Medicinal and Narcotics Law, including GMP and GDP. Therefore, the BfArM (the Federal Institute for Drugs and Medical Devices) has taken over new responsibilities by establishing the Cannabis Agency. This agency is meant to help in ensuring supplies for medical-quality Cannabis.
Unlike AGES in Austria, though, where cultivation of medical cannabis has already been established, cannabis will not be cultivated by BfArM itself, but by commissioned companies. Cannabis is not meant to be stored directly at BfArM during any stage of the purchasing, harvesting or distribution process. These steps will be carried out by relevant producers or other commissioned companies (i.e. suppliers, importers). Hence, the agency will manage and monitor the cultivation, harvest, processing, quality assurance, storage, packaging and distribution of cannabis to wholesalers, chemists or manufacturers.
The GMP inspectorates are responsible for issuing manufacturing and import licenses or GMP Certificates. Thus, they will perform inspections at the sites of manufacturers who apply for these certificates and licenses.
In summary:
Unlike AGES in Austria, though, where cultivation of medical cannabis has already been established, cannabis will not be cultivated by BfArM itself, but by commissioned companies. Cannabis is not meant to be stored directly at BfArM during any stage of the purchasing, harvesting or distribution process. These steps will be carried out by relevant producers or other commissioned companies (i.e. suppliers, importers). Hence, the agency will manage and monitor the cultivation, harvest, processing, quality assurance, storage, packaging and distribution of cannabis to wholesalers, chemists or manufacturers.
The GMP inspectorates are responsible for issuing manufacturing and import licenses or GMP Certificates. Thus, they will perform inspections at the sites of manufacturers who apply for these certificates and licenses.
In summary:
- The Cannabis Agency is responsible for ensuring that only medical grade cannabis is supplied,
- The relevant requirements based on the underlying legal framework (including Pharmacopoeias) and the corresponding GMP, GDP and GACP guidelines must be complied with, and finally
- Cannabis for medical purposes is also subject to the provisions of the German Narcotics Law.
Target Group
This conference addresses specific GMP aspects to consider for Growers, Manufacturers, Start-Ups, Suppliers, Importers, QPs and QA personnel involved in Cannabis production. The topics provided are also of interest for GMP/GDP Inspectors responsible for issuing a GMP certificate or manufacturers- / import license.
Programme
Welcome and Introduction
- GMP for Cannabis: setting the scene
Greek law for Pharmaceutical Cannabis - A reliable framework for final medical products with Cannabinoids
- GMP and GACP in Greece
- Possible pitfalls and strategies to avoid them
- Timeframe and steps to acquire a license
- Greek National Organization for Medicines (EOF)
- Future issues to be solved
GMP Certification / Manufacturing and Importation Authorization
- Aspects to consider for applications for Manufacturing and Importation Authorizations
- Aspects to consider for analytical labs
- GMP certification: What you need to know
- Inspections in Europe and beyond: Typical and recurrent compliance issues
Narcotic drugs – The regulations
- Short overview of the German Narcotics Law („Betäubungsmittelgesetz“, BtMG)
- Necessary documents for granting general licenses and import / export authorizations by the Federal Opium Agency (BfArM)
- Surveillance with respect to inspections
- Reasons for refusal
GDP for Cannabis
- Requirements for transport to pharmacies, veterinary dispensaries, hospitals
- Requirements for distribution of cannabis through international distribution partners, wholesalers and 3PL partners
Quality of medicinal Cannabis and Extracts
- What to test
- How to test
- Limits
- Challenges and problems
Steps of Growing Cannabis according to GACP
- Facility plan, design, set up – Hurdles and Solutions
- From Seed to…
- …Harvest and drying
Supplier qualification and handling (facilities, packaging, release)
- Requirements to fulfil
- Agreements & Responsibilities
- EU GMP Conformity & Import License
- Stability studies, shelf life
Experiences - Lessons learned
- Application of GMP principles to Cannabis
- Quality management System (QMS) including Qualification/Validation
- DAB Monograph “Cannabis Flos”: Points to consider