Note: All times mentioned are CET. For participants of the post-conference only- Every participant will receive the printed version of ECA´s Cannabis Roadmap - Global GMP Requirements and Regulatory Information on Medicinal Cannabis (and CBD Products)!- Non-official English translations of the German Pharmacopoeia (DAB) Monographs Cannabis flower and Cannabis Extract for download
Zielsetzung
In addition, more and more countries around the world legalize cannabis for medical use. But what qualifies as medical grade cannabis? And which aspects have to be considered in particular during Qualification/Validation? The dedicated Post-conference will provide you with the necessary details for medical cannabis products.
Hintergrund
- Which contaminants have to be considered?
- Which microbiological provisions apply?
- Which kind of decontamination procedures can be used?
- Are there different requirements for herbal drugs, herbal
Moreover, Qualification and Validation is an essential GMP requirement. Non-EU suppliers, who currently produce according to GPP, will have to implement EU-GMP standards if they want to supply herbal drugs like medical cannabis to the EU market. But which requirements apply? And what does it mean in practice? The post-conference will specifically answer these questions and provide you with practical examples.
Zielgruppe
Technical Requirements
Programm

Gesamtes Programm als PDF herunterladen
- Definitions
- Marketing authorization and registration
- Particularities of Traditional Herbal Medical Products
- Quality aspects and GACP confirmation
- Borderline GACP-GMP
- Types of extracts
- Control strategy for extracts and drug products
- Context with clinical data and regulatory pathway
- Is a complete dossier always required?
- Pharmacopoeial definition (Ph. Eur.)
- Different types of HRS
- Active and analytical markers
- GACP Guideline
- Herbal drugs: “Special APIs”? - EU GMP Part II
- EU GMP Part I and Annex 7
- Points to consider
- Regulatory basis for risk-based testing for medicinal products with herbal ingredients
- Procedure for the development of test concepts based on risk analyses
- Different scopes of testing for release and re-testing of starting materials
- Current examples of risk-based testing for contaminants:
- Example 1: Pyrrolizidine Alkaloids
- Example 2: Elemental Impurities (ICH Q3D)
- Example 3: Aflatoxins
- Process Design
- Qualification / validation
- Extraction Solvents
- Sampling and Testing Operations
- Typical microflora of medicinal plants
- Requirements for the microbiological quality of herbal medicinal products
- Microbiological test methods and proof of suitability
- Decontamination methods for herbal starting materials
- Experiences from authority inspections
- Stability testing - general requirements
- Characteristic of HMPs
- Particular aspects of HMPs:
- Markers, methods, fingerprints, validation
- Shelf-life / re-test date
- OOS / OOT Results
- Quality management System (QMS)
- Quality Risk Management (QRM)
- Points to consider
- Solutions to control and monitor facilities in a safe, efficient and GMP-compliant manner
- Qualification of equipment / rooms / facilities / utilities (Systems)
- Qualification / Validation Master Plan (VMP)
- Principles of Quality Risk Management (QRM)
- How to identify critical parameters
- The main concept to set-up a Cannabis production facility
- The zone concept, general layouts, hygienic aspects
- How to integrate GMP requirements in the Project
- How to deal with the authority
- How to qualify suppliers
- Realization of Qualification and Validation in practice
- Changing Rooms – Air-locks - Zoning Concepts
- Room Design and Room Separation
- Drying Process – What needs to be done?
- Points to consider
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