Requirements for the decontamination of medicinal cannabis flowers – (11143)

prerequisites, qualification, validation, data collection and evaluation, and demarcation of responsibilities

The microbiological quality of cannabis flowers should be optimised through appropriate measures during cultivation, processing and storage, as well as through the selection of suitable packaging materials and transport conditions. This is in line with the guidance set out in the EMA “Reflection paper on microbiological aspects of herbal medicinal products and traditional herbal medicinal products” (EMA/HMPC/95714/2013). As a first step, appropriate hygiene measures should therefore always be taken to ensure that the microbiological contamination of the flowers is kept to a minimum. Nevertheless, decontamination processes are increasingly being used. There are various reasons for this.

In the past, cannabis flowers were primarily decontaminated using ionising radiation. In most EU Member States, the use of such processes requires official authorisation and/or an approval procedure in order to be permitted to place flowers treated in this way on the market. In Germany, the BfArM has published a guidance note on this subject on its website and established an application procedure. Applications must be submitted by the importer/distributor, who must provide extensive data on the validation and qualification of the process. Irradiation must take place in a facility holding a GMP manufacturing licence. To circumvent this authorisation procedure, alternative methods are increasingly being used; these are often not adequately qualified or validated and are not always carried out in facilities with a GMP manufacturing licence. Every application of bioburden-reduction processes carries risks to the quality, efficacy and safety of cannabis flowers. This gives rise to obligations for the various stakeholders in the value chain, as well as corresponding liability risks.

Decontamination processes are fundamentally critical manufacturing steps and therefore require comprehensive qualification of the equipment used and validation of the underlying processes, not only in accordance with EU GMP.

This webinar aims to outline the requirements for the qualification and validation of such processes and to highlight the obligations of the stakeholders and the corresponding demarcation of responsibilities within the value chain. The webinar is also adressing competent authorities, with the aim of initiating a discussion that will ideally lead to a harmonization of expectations and requirements within and between EU member states.

Topics covered:

• Basic requirements for the microbiological quality of medicinal cannabis flowers in the EU and their link to GACP and GMP obligations, respectively
• EU GMP requirements, necessary data and their evaluation in the context of qualification and their application to facilities apparatus used for decontamination
• Validation of decontamination procedure
  • Process-related target parameters to be considered
  • Product-related target parameters to be considered
• Specific problems of sampling
• Data required for qualification, validation and stability: Type and scope, collection, analysis and evaluation and documentation
• Definition of responsibilities in the value chain – from cultivation to dispensing in the pharmacy
• QP responsibilities in the context of batch release
• Responsibilities in the context of plausibility checks in the pharmacy

Duration: approx. 180 minutes
Presentation language: English
Speaker: Dr. Markus Veit

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