In the production of medicinal cannabis, compliance with Good Manufacturing Practice (GMP) is crucial to ensure the quality and safety of cannabis products. This is particularly important as medicinal cannabis is intended for patients with serious medical conditions.
GMP compliance is mandatory for the manufacture of medicinal cannabis and import in the European Union (EU). This GMP compliance requires, among other things, the establishment of a pharmaceutical quality system (PQS), the qualification of manufacturing facilities and equipment, the validation of production processes and the training of personnel.
The EU has no specific quality requirements for medicinal cannabis. Herbal medicinal products are covered by the EU GMP Guide and specific annexes as Annex 7 Manufacture of Herbal Medicinal Products.
The "Guideline on good agricultural and collection practice (GACP) for starting materials of herbal origin (EMEA/HMPC/246816/2005)" is also a good source and is currently under revision (EMEA/HMPC/246816/2005 Rev. 1).
Another important document is the "Final guideline on quality of herbal medicinal products/traditional herbal medicinal products – Revision 3 (EMA/HMPC/CHMP/CVMP/201116/2005 Rev. 3)".
The GMP Compliance Adviser Assures GMP Compliance
To help you achieve GMP compliance, we recommend you explore the wealth of resources available on the GMP Compliance Adviser online portal. It offers GMP knowhow and expertise compiled from industry professionals, regulatory authorities, and consultants. It provides a comprehensive insight into GMP regulations for medicinal products and active substances and their practical interpretation.
The GMP Compliance Adviser is a widely accepted resource for GMP interpretation in the pharmaceutical industry. It also supports the manufacture of herbal medicines, including medicinal cannabis products, to meet GMP requirements.
From Standard Operating Procedures (SOPs) to checklists and beyond, this platform equips professionals with the tools they need to effectively navigate the complex regulatory landscape.
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