GMP for Herbal Medicinal Products (HMPs) + Post Conference on Qualification & Validation Aspects for Cannabis - Live Online Conference
8/9 November 2022
Course No. 20172
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
Objectives
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.
Background
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.
Target Group
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.
Technical Requirements
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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 (QRM)
Points to consider
Final Discussion
Post-Conference on Qualification & Validation Aspects for Cannabis (for Growing, Processing, Handling and Storage of Medical Cannabis) - 9 November 2022
Environmental Control and Monitoring
Solutions to control and monitor facilities in a safe, efficient and GMP-compliant manner
Process Validation & Equipment Qualification
Qualification of equipment / rooms / facilities / utilities (Systems)
Qualification / Validation Master Plan (VMP)
Principles of Quality Risk Management (QRM)
How to identify critical parameters
Case study: A New Production Facility for Cannabis
The presentation will provide insight in:
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
Experiences / Lessons learned
Changing Rooms – Air-locks - Zoning Concepts
Room Design and Room Separation
Drying Process – What needs to be done?
Points to consider
Final Discussion
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Testimonials
Seminar Programme as PDF