GMP for Herbal Medicinal Products (HMPs) - Live Online Conference

8/9 November 2022

Seminar-Nr. 19313


Dr. Ingrid Walther

Dr. Ingrid Walther

Pharma Consulting Walther

Dr. Ulrich Rose

Dr. Ulrich Rose


Note: All times mentioned are CET.


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.

Technische Voraussetzungen

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.


GMP for Herbal Medicinal Products (HMPs) - Live Online Conference

Gesamtes Programm als PDF herunterladen

Programme - 8 November 2022
The Regulatory Framework for HMPs
  • Definitions
  • 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
Final Discussion

Dieses Seminar/Webinar kann nicht gebucht werden. Alternative Termine für dieses Seminar/Webinar und ähnliche Veranstaltungen finden Sie in der Übersicht nach Thema..

Für viele Seminare und Webinare gibt es auch Aufzeichnungen, die Sie jederzeit bestellen und anschauen können. Diese Aufzeichnungen finden Sie in einer themensortierten Liste.

Oder senden Sie uns Ihre Anfrage einfach über das folgende Kontaktformular.

* auch unkompliziert per Kreditkarte bezahlbar
American Express Visa Mastercard

Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
Weitere Termine online
Weitere Termine online nicht verfügbar
Aufzeichnung nicht verfügbar

Haben Sie noch Fragen?

Wir stehen Ihnen für weitere Auskünfte gerne zur Verfügung.
Tel.: +49 6221 84 44 0
E-Mail: info@concept-heidelberg.de

Frau mit Headset


Teilnehmerstimmen - das sagen andere über unsere Seminare:

"Die Umsetzung mit Memberspot ist wirklich ausgezeichnet gelungen.
Es unterstützt die Wissensvermittlung und gewährleistet auch die richtige Durchführung des Kurses.”
Christian Wagener, WAGENER & CO. GmbH
GMP Basis-Einstiegsschulung (B 1) - Aufzeichnung Online Seminar, April 2024

Guter, breit gefächerter Überblick mit interessanten Verknüpfungen zur Praxis,
welche die Theorie super veranschaulicht.”
Marina Kicoranovic, Labor Hartmann GmbH
GMP/Basis-Einstiegsschulung (B 14), September 2023

Die Referenten waren sehr gut! Sie haben sehr klar gesprochen, nur sehr wenige englische Begriffe
verwendet (super) und waren sehr praxisbezogen.”
Astrid Gießler, Regierungspräsidium Karlsruhe
Live Online Seminar - Basiskurs Computervalidierung & Datenintegrität im GxP Umfeld (B 3), Juni 2023

Sehr guter Bezug zur Schulung für einen GMP-Anfänger. Habe mich sehr gut abgeholt gefühlt.”
Dr. Harald Werner, Infraserv GmbH & Co. Höchst KG
GMP-Basisschulung (B 1), Juni 2023

„Interessante Themen, gut vorgetragen, die eigenen Erfahrungen der Vortragenden helfen, dies noch besser nachzuvollziehen.“ „Gute Gestaltung der Workshops, das Zusammenarbeiten in Gruppen und der Austausch mit anderen hilft sehr.“
Manuela Seibert, Merck, GMP-Leadauditor/in (FA 2), April 2024


Bleiben Sie informiert mit dem GMP Newsletter von Concept Heidelberg!

GMP Newsletter

Concept Heidelberg bietet verschieden GMP Newsletter die Sie auf Ihren Bedarf hin zusammenstellen können.

Hier können Sie sich kostenfrei registrieren.


Kontaktieren Sie uns

Haben Sie Fragen?

Concept Heidelberg GmbH
Rischerstraße 8
69123 Heidelberg

Tel. :+49622184440
Fax : +49 6221 84 44 84
E-Mail: info@concept-heidelberg.de

zum Kontaktformular