Isabel Cordeiro, Clever Leaves, Portugal
Dr Henrik Harms, BfArM, Germany
Dr Timo Krebsbach, HHAC Labor Dr. Heusler, Germany
Dr Nandakumara D Sarma, USP, USA
This Live Online Training is intended to provide information on the different aspects of stability testing for medical cannabis. The conference will provide an overview of regulatory requirements with a special focus on the ICH and EMA Guidelines. In the subsequent presentations, important aspects of stability testing for cannabis flower and cannabis extracts are discussed. The specific requirements for stability testing of herbal drugs which are narcotics are challenging. E.g. storage needs to be done in climate chambers in specifically designed and secured facilities. In addition, specific rules have to be followed concerning transport, waste and documentation. These aspects will also be covered.
More and more countries around the world are introducing programs in order to legalize cannabis for medical use. These products, however, must comply with the relevant requirements laid down under Medicinal and Narcotics Law, including Pharmacopoeias and GACP/ GMP / GDP Guidelines.
In some countries, like for example Canada and New Zealand, cannabis production is usually performed under GPP, where stability testing is not required. Under EU GMP, however, an ongoing stability programme is mandatory. Medicinal Products have to be labelled with an expiry date.
Therefore some of the frequently asked questions are:
- Which specific parameters have to be tested during stability studies?
- Which specification limits apply?
- How to establish a re-test period for APIs or a shelf life for drug products?
- How to deal with OOS and OOT results?
This online course will address how to set up a stability programme for cannabis related products. Specific aspects like bracketing and matrixing according to the ICH Q1 Guidelines will be covered. In addition, the specific rules for herbal medicinal products (HMPs) and narcotics will be discussed.
This Live Online Training addresses specific aspects related to stability testing to consider for Growers, Manufacturers, Start- Ups, Suppliers, Importers, QPs and QA/QC/Regulatory Affairs personnel involved in Cannabis production. The topics provided are also of interest for GMP Inspectors responsible for issuing a GMP- certificate or manufacturers-/ import license.
For our Live Online Training Courses and Webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At https://www.webex.com/test-meeting.html
you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because
of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
Note: Provisional timetable, the actual schedule may vary depending on the situation.
10.00 – 10.15 h Welcome and Introduction
10.15 – 11.15 h
General ICH & EMA Principles and Requirements / Specific Aspects for HMPs
- Stability testing, in-use stability
- Re-test period, Shelf life and storage conditions
- Focus on herbal substances / preparations / medicinal products
- Bracketing and Matrixing
11.15 – 11.30 h
Time for Discussion
11.30 – 11.45 h Break
11.45 – 12.45 h
Challenges & Solutions due to the Narcotics Law
- Regulatory and technical requirements before / during / after stability testing
- Import / export, delivery, acquisition
- Destruction of narcotics
- How does a compliant outsourcing of stability testing succeed?
12.45 – 13.00 h
Time for Discussion
13.00 – 14.00 h Break
14.00 – 15.00 h
Recommended Quality Attributes for Cannabis Inflorescence from the USP Cannabis Expert Panel as a potential Objective for Stability Testing
- Specifications for cannabinoids and limits for contaminants
- Test for stability-indicating degradant: CBN
- Recommended storage conditions
15.00 – 15.15 h
Time for Discussion
15.15 – 15.30 h Break
15.30 – 16.30 h
Practical Stability Experiences for Cannabis Flower and Extracts
- The challenges setting up stability studies for medicinal cannabis and complying with ICH Q1
- From the set up of the study, finding the right lab to perform the study, import /export licenses for the material and standards up to the final results- logistics is a nightmare compared with regular APIs and finished products
- Interpreting data and making sure regulatory requirements are met
16.30 – 17.00 h
USP General Notices section 3.10 Applicability of Standards: The standards in the relevant monograph, general chapter(s), and General Notices apply at all times in the life of the article from production to expiration. It is also noted that the manufacturer’s specifications, and manufacturing practices, generally are followed to ensure that the article will comply with compendial standards until its expiration date, when stored as directed. Every article in commerce shall be so constituted that when examined in accordance with these assays and test procedures, it meets all applicable pharmacopeial requirements (General Notices, monographs, and general chapters).