Dr Cornelia Bodinet, Schaper & Brümmer, Germany
Dr René Roth-Ehrang, Finzelberg, Germany
Univ-Doz. Dr Reinhard Länger, Austrian Agency for Health and Food Safety (AGES)
Dr Margit Müller, WALA Heilmittel, Germany
Dr Ulrich Rose, formerly EDQM, France
Anke Steuber, PhytoLab, Germany
Dr Jonathan Thompson, United Science, USA
Dr Ingrid Walther, Pharma Consulting Walther, Germany,
Leader of the ECA Cannabis Working Group
The course will provide you with the necessary GMP/GACP knowledge for Herbal Drugs, Herbal Drug Preparations (e.g. Extracts) and Herbal Medicinal Products (HMPs). This includes regulatory & quality requirements as well as applicable pharmacopoeial monographs and challenges often encountered in HMPs, e.g. during stability studies.
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.
Herbal Medicinal Products are accepted and widely-used remedies. Although several routes exist for HMPs to receive a marketing authorization, e.g. well-established or traditional use – or special cases like medical cannabis as “Formula magistralis / officinalis” without marketing authorization - they all need to fulfill the same pharmaceutical quality standards. However, HMPs have some very specific characteristics that must be taken into consideration for GMP compliant production, quality control, release and stability testing. Questions often raised include the following:
- 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 drug preparations (like extracts) and the final HMP?
To provide more detailed information on these requirements, the European Medicines Agency (EMA) recently published the final guidelines (Revision 3) on quality and specifications for herbal medicinal products (HMPs). Amongst others, a written GACP confirmation for the herbal substance should be provided either by the herbal drug supplier or the manufacturer of the active substance / the HMP. In addition, EMA´s HMPC is currently working on the revision of the GACP guideline and recently already published a concept paper.
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.
This course is designed for all people in pharmaceutical and API industry’s quality control, regulatory affairs, pharmacovigilance, production and purchasing departments who need to establish, monitor and/or manage the quality of Herbal Drugs / Herbal Medicinal Products. The Post-conference specifically addresses Qualification/Validation aspects to consider for Growers, Manufacturers, Start-Ups, Suppliers, Importers, Wholesalers, QPs and QA/QC personnel involved in Cannabis production.
We use Webex Events for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information
you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.
Programme - 8 November 2022
The Regulatory Framework for HMPs
- Marketing authorization and registration
- Particularities of Traditional Herbal Medical Products
- Quality aspects and GACP confirmation
Quality Requirements for Marketing Authorization Applications
- 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?
Herbal Reference Standards (HRS)
- Pharmacopoeial definition (Ph. Eur.)
- Different types of HRS
- Active and analytical markers
Q&A Session 1
EU GMP Annex 7 / GMP vs GACP
- GACP Guideline
- Herbal drugs: “Special APIs”? - EU GMP Part II
- EU GMP Part I and Annex 7
- Points to consider
Contaminants – A Risk based Approach
- 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
GMP Aspects for Extracts
- Process Design
- Qualification / validation
- Extraction Solvents
- Sampling and Testing Operations
Q&A Session 2
Programme - 9 November 2022
Current Requirements for the Microbiological Testing of HMPs
- 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
Challenges in Stability Studies
- Stability testing - general requirements
- Characteristic of HMPs
- Particular aspects of HMPs:
- Markers, methods, fingerprints, validation
- Shelf-life / re-test date
- OOS / OOT Results
Experiences from GMP Inspections / Audits
- Quality management System (QMS)
- Quality Risk Management (QRMS)
- Points to consider