In this blog post, Elle, our Territory Account Manager – North & Nordics, looks at the regulations governing the emerging trend of CBD production and how they impact cleanroom design.
The EU has classified Cannabidiol (CBD) as an unapproved ‘novel food’, whereas the MHRA released a statement in 2016 classifying CBD used for medical purposes as a medicine. Medicinal products must have a product licence (marketing authorisation) and be manufactured according to GMP guidelines (and the latest draft of Annex 1).
Non-medicinal products may be exempt from requiring a product licence and could be potentially be manufactured in non-GMP grade cleanrooms if exemption is granted. However, if you know that your business has plans to obtain a product licence in future, it would be worth starting from scratch with a GMP grade cleanroom.
Any CBD manufacturer must also work with the MHRA to satisfy the legal requirements of the Human Medicines Regulation Act 2012.
Cleanroom Planning and Design
To minimise risk for the end-user, all manufacturers or packagers of CBD products should follow appropriate contamination control strategies.
Critical parameters to consider during facility design include, but are not limited to, optimal temperature control, cleaning procedures to avoid cross-contamination, plus Hazard Analysis and Critical Control Point (HACCP) guidelines around your microbiology and hazard points.
Segregation of areas will also need to be factored into your design flow, as separate equipment is required for any different processes taking place. Storage areas for raw materials and finished products will also need to remain separate, and more than likely lockable due to the value of goods both before and after they have been processed.
Now let’s look at what’s required - any manufacturer or assembler of a Schedule 2 drug (as CBD is defined) requires a Home Office Controlled Drug licence for importing and exporting purposes.
Unless exempt, medicines must have a product licence (marketing authorisation) before being placed on the market. Exempt products may be supplied as ‘specials’ by an appropriate prescriber. A ‘special’ can only be supplied in order to meet the special needs of an individual patient and may not be advertised.
The manufacturing or assembly site will also be inspected for compliance with cGMP guidelines and the conditions of the granted licence. These stipulate that manufacture is carried out under the supervision of appropriately qualified staff, including a named Qualified Person (QP), Quality Controller and Production Manager, who are acceptable to the Licencing Authority.
Our fully-flush monobloc panel cleanrooms are compliant with GMP guidelines and have the capability to be upgraded in future, with additional fan filter units added to provide an uplift in classification, in-line with your growth plans. Whether non-medicinal or medicinal, a cleanroom environment will certainly ensure you work under best practice for manufacture, filling and packaging of your products.
Contact us today if you have any more questions on how to ensure compliance with CBD manufacture and we can certainly find the right solution for you.