Dr Ulrich Rose
Straßburg
Referent:innen
Dr René Roth-Ehrang
Finzelberg
Dr Evelyn Wolfram
Zurich University of Applied Sciences
Dr Henrik Harms
BfArM
Dr Nikos Xynos
Nomad Labs Scientific
Philip Junker Andersen
IntuBio
Joaquin Dell’Acqua
Agronomist
Dr Gerlinde Kugler
Austrian Agency for Health and Food Safety (AGES)
Note: All times mentioned are CEST.
Zielsetzung
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.
Hintergrund
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 draft paper.
Zielgruppe
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.
Date & Technical Requirements
Date 08/09 October 2025
Wednesday, 8 October 2025, 9.00 to approx. 17.30 h (CEST)
Thursday, 9 October 2025, 9.00 to approx. 13.00 h (CEST)
Wednesday, 8 October 2025, 9.00 to approx. 17.30 h (CEST)
Thursday, 9 October 2025, 9.00 to approx. 13.00 h (CEST)
Technical Requirements
We use Webex for our live online training courses and webinars. At 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.
Programm
Programme - 8 October 2025
Do Phytopharmaceuticals have a Future?
- Regulatory hurdles and growing competition with dietary supplements
- Challenges in the Lifecycle management of herbal medicines
- How a modernization of EU regulations could help
- Health claims Issues
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?
Quality Control and Stability Testing: Specific Aspects for HMPs
- Stability testing, in-use stability vs on-going stability
- Re-test period, Shelf life and storage conditions
- Focus on herbal substances / preparations / medicinal products
- Bracketing and Matrixing
Q&A Session 1
Herbal Drugs & Herbal Drug Preparations in the European Pharmacopoeia (Ph. Eur.)
- General / Individual Monographs & General Texts
- Pyrrolizidine Alkaloids (PAs)
- Alternatives for Assays
- Outlook
Herbal Reference Standards (HRS)
- Pharmacopoeial definition (Ph. Eur.)
- Different types of HRS
- Active and analytical markers
GMP and Technology Considerations for Extraction and Purification of Herbal Active Compounds
- Processes and Methods
- Different extraction, refining and purification Technologies
- Key considerations for GMP compliance in integrated processes and Technologies
- Environmental impact, cost efficiency, and operational aspects
Q&A Session 2
Programme - 9 October 2025
From Field to Facility: Lessons from Annex 7 vs GACP and Inspections
- Regulatory Aspects
- Quality management System (QMS)
- Quality Risk Management (QRM)
- Points to consider
Cultivation under GACP
- Cultivation and the implementation of GACP Standards
- Practical insights
- Case studies
Requirements & Challenges 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
Final Discussion
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