Tests in the New Ph. Eur. Monograph on Cannabis Flower

26.02.2024

LOGFILE Feature

5 min. reading time | by Sabine Paris
Published in LOGFILE 5/2024

The monograph on Cannabis flower (3028) has been published in Ph. Eur. Supplement 11.5 in January 2024, with an implementation date of 1 July 2024.
All member states of the European Pharmacopoeia are required to replace their national monographs with this new Ph. Eur. Monograph.

Today’s feature lists the tests required by the new monograph and provides first-hand background information from the EDQM.

The monograph on Cannabis flower (3028) has been published in Ph. Eur. Supplement 11.5 in January 2024, with an implementation date of 1 July 2024. All member states of the European Pharmacopoeia are required to replace their national monographs with this new Ph. Eur. Monograph.

Existing national monographs have been used in the preparation of this new monograph, e. g. the monographs of Germany, Denmark, the Netherlands and Switzerland.

The Ph. Eur. monograph on Cannabis flower covers the herbal drug used as a raw material for the production of extracts, or prescribed as is, to be taken by patients by inhalation or oral administration (i.e. prescribed to patients as a medicinal product).

The European Directorate for the Quality of Medicines and HealthCare (EDQM) presented key points and background information in a webinar on 14 December 2023.

This feature summarises the necessary tests required by the monograph.

Figure 1 Test of Ph. Eur. Cannabis flower monograph

A specification for moulds is not included in the monograph but this is covered in the general chapter on foreign matter (2.8.2) – ‘other foreign elements‘. A risk assesment shall be carried out for the control of moulds. The sampling procedure and the expected appearance of the herbal drug are defined. Mould control is also covered by GACP (Good Agricultural and Collection Practice).

Other applicable tests according to the general monograph Herbal Drugs (1433) are:

Figure 2 Other test from the monograph Herbal Drugs (1433)

Test for other aflatoxins than aflatoxin B₁ are not included in the monograph because Cannabis flower does not present a particularly high risk of being affected by fungal infections. Cannabis flos does not have a particularly high sugar content.

A test for total ash is not included in the monograph because mineral contamination of Cannabis flower is expected to be very low.

Sources

Ph. Eur. Monograph on Cannabis flower (3028)

EDQM-Webinar: The new Ph. Eur. Cannabis flower monograph (3028), Thu, Dec 14, 2023

Do you have any questions or suggestions? Please contact us at: redaktion@gmp-verlag.de

Dr. Sabine Paris Published on 26 February 2024

You may also be interested in the following articles:

15.06.2026

LOGFILE Feature

Damage Control: Complaints and Recalls

Complaint handling and product recalls are important components of the Pharmaceutical Quality System (PQS). They serve to identify defective medicinal products and ensure that appropriate measures are taken to protect patient safety, as required by law and the competent supervisory authority.

What are the Phases of a Working Cycle During a Steam Sterilisation Process?

15.06.2026

Question of the Week

What are the Phases of a Working Cycle During a Steam Sterilisation Process?

Here's the answer:

14.06.2026

News

EMA: 9 New Nitrosamines for Appendix 1

Appendix 1 of EMA’s Questions and Answers on nitrosamine impurities has been updated. This appendix contains acceptable intakes (AIs) established for N-nitrosamines.

EMA: Reduced Testing of Incoming Starting Materials is a GMP Matter

05.06.2026

News

EMA: Reduced Testing of Incoming Starting Materials is a GMP Matter

The European Medicines Agency (EMA) published an update to its “Quality of Medicines: Questions and Answers – Part 2”. The revision concerns the section on “Reduced testing of incoming starting materials”.

What Types of Impurities may be Present in Active Substances?

01.06.2026

Question of the Week

What Types of Impurities may be Present in Active Substances?

There’s Something in the Air – Cleanroom Technology in the Pharmaceutical Industry

01.06.2026

LOGFILE Feature

There’s Something in the Air – Cleanroom Technology in the Pharmaceutical Industry

In pharmaceutical manufacturing, clean air is not a subjective perception but a precisely controlled technical condition that is essential for product safety. Heating, ventilation and air-conditioning (HVAC) systems ensure, through airflow management, air filtration and pressure control, that particles and microorganisms are kept away from critical areas. This is based on clearly defined requirements for air changes, cleanliness classes, airflow patterns and pressure concepts, all of which are designed according to the manufacturing process and contamination risk involved.

Related Products

GMP Compliance Adviser | Named User Licence | 12M

The GMP Compliance Adviser is an online publication that covers all aspects of Good Manufacturing Practice (GMP) in one source.In the GMP Compliance Adviser you’ll find: GMP in Practice This part contains 21 chapters with GMP expert knowledge to base your decisions upon. It provides practical assistance with checklists, templates and SOP examples. It is written by more than 80 authors with hands-on experience directly linked to the industry. The individual chapters describe the different aspects of GMP in clear language. Technical, organizational and procedural aspects are covered.More than 700 checklists, templates and examples of standard operation procedures taken directly out of practice help you in understanding the GMP requirements.GMP RegulationsThese chapters cover the most important GMP regulations from Europe and the United States (CFR and FDA), but also PIC/S, ICH, WHO and many more. Sample Documents In addition, the GMP Compliance Adviser contains many sample documents and practical examples that you can use.

delivery time appr. 2-5 workdays

€1,368.00 net excl. VAT

Details

GMP:KnowHow Pharma Logistics (GDP) | Named User Licence | 12M

Your knowledge base about GDP-compliant handling of your pharmaceutical logistics. It is important that you as a logistics service provider, but also as a client in the pharmaceutical industry, adhere precisely to the regulatory requirements. The GMP:KnowHow knowledge portal guides you through the regulatory jungle of the pharmaceutical and logistical supply chain! The knowledge portal gives you an easy-to-understand overview of all the important topics. Using graphics, you can easily navigate through all the areas covered by the EU GDP Guidelines (2013/C 343/01). You also have the relevant passages of the regulations directly at hand for each topic. This allows you to compare the requirements directly and saves you a lot of time on time-consuming searches and research!One thing is certain: the knowledge portal answers your questions about the supply chain of medicinal products, active pharmaceutical ingredients and medical devices. You don't have to be an expert. Yet.You will find answers to your questions in the GMP:KnowHow Pharma Logistics (GDP). Where does GDP begin, where does GMP end? What does GDP-compliant mean? When do I also have to take GMP requirements into account? What permits do I need for certain activities? What requirements do I have to fulfil? What is the current legal basis? How am I covered? What authorizations do I have for my work, e.g. from my employer? Who is responsible — the client or the contractor? And many more What is the difference to the GMP Compliance Adviser? The GMP:KnowHow Pharma Logistics (GDP) is your guideline for Good Distribution Practice. It is a product that is independent of the GMP Compliance Adviser and concentrates on content that is essential for carriers of medicinal products, active pharmaceutical ingredients and medical devices as well as for logistics clients. The focus is on practical knowledge and how to apply it in your daily business. If necessary, the relevant regulations can be called up immediately alongside the practical knowledge, and you can see the relevant paragraphs at a glance. In addition, sample documents are available to help you make immediate progress. AuthorSimone Ferrante – now Director Quality at Fisher Clinical Services – was previously Head of Quality Control and Responsible Person according to GDP (VP) for the entire Grieshaber Group. She is also a long-standing author and GDP expert at GMP-Verlag.

delivery time appr. 2-5 workdays

€610.00 net excl. VAT

Details

E-Learning GMP:READY | Specialist Knowledge GMP for Engineers

Why are GMP rules important for technicians and engineers? Technicians and engineers play a key role in ensuring compliance with Good Manufacturing Practice (GMP) standards. They are involved in critical activities such as: planning and construction of ventilation systems, maintenance of water treatment plants, calibration of measuring sensors. Therefore, they are jointly responsible for the quality of medicines and must ensure that their work complies with GMP standards.Your advantages: Fast familiarization with GMP topics in approx. 2 hours, time- and location-independent online training, printable personal certificate, 12-month access for initial and follow-up training, automatic updates in case of legal changes,content compliant with Article 7(4) of Directive 2003/94/EC.The Author This e-learning course was developed with the collaboration of Dipl.-Ing. Andreas Nuhn (D & B Pharmadesign GmbH).

delivery time appr. 2-5 workdays

€245.00 net excl. VAT

Details

GMP Fundamentals | A Step-by-Step Guide

This handbook is a practical and easy to read guideline, giving you a quick and comprehensive overview of the complex world of Good Manufacturing Practice (GMP) without the need of previously acquired knowledge. Some topics are: GMP: Purpose and basic pharmaceutical terms Laws, licenses and inspections Personnel: Responsibility and hygiene Standard Operating Procedures (SOP) and documentation Design of rooms and facilities Processing and packaging Quality control and market release Suppliers, storage and logistics (Good Distribution Practice = GDP) Alphabetical index and abbreviations Using practical examples and comparisons to every-day life will help to easy understand GMP regulations.GMP Fundamentals is a helpful guide which facilitates the entry into the GMP world and teaches the necessary basics.

delivery immediately after receipt of payment

€44.90 net excl. VAT

Details