The 9 Basic Principles of GMP and how they apply to the European cannabis industry
These three letters have become a watchword of the cannabis industry – particularly in Europe, but what exactly are the basic tenets of the same?
by Marguerite Arnold
GMP – or good manufacturing principles – is a standardized process used in the pharmaceutical industry, globally, to ensure that the production and distribution of drugs is standardized, and that patient safety is paramount.
Poor quality drugs are a disaster for everyone – and that includes cannabis in both the raw flower and produced form.
So far, in the German market, for example, there have been several incidences where product (including raw flower) has been recalled.
9 Principals of GMP
There is no one “way” or method to obtain GMP certification, but there are several basic principles that all GMP guidelines follow.
- The production and distribution of drugs must minimize any quality risk.
- Manufacturing facilities must be clean and hygienic.
- The production facility design, operations and environmental conditions must be controlled to prevent cross contamination from any other kind of product (labelled or unlabelled)
- Manufacturing processes must be clearly defined, validated, and controlled.
- Instructions and procedures must be written in clear language.
- Operators must be trained to carry out production and control procedures as documented.
- Records must be made during manufacture and quality control, demonstrating that all the necessary steps required by the defined procedures and instructions were executed properly. Deviations must be investigated and documented.
- There must be a system for managing recalls, by batch.
- Complaints must be examined, investigated and if defects are found, appropriate measures must be taken to rectify the situation and prevent another occurrence.
GMP and European Cannabis Imports
Importing cannabis into European countries is a complex process. It is also complicated by where the cannabis is cultivated and where it enters the EU if cultivated or processed outside of the region.
If cannabis is cultivated within the EU (for example Portugal or Holland), onsite inspections by the country of destination (i.e., regulators from BfArM if entering Germany) do not need to occur. However, one of the biggest issues right now is that the regulatory agencies across Europe are not coordinating efforts and procedures for certifying cannabis.
Depending on the MRA (or mutual recognition agreement) between the importing and exporting country when outside of the EU, inspectors from the importing country must literally walk the floors with an on-site inspection.
What Steps Are Necessary for obtaining an EU GMP certificate?
There are six steps to obtain an EU GMP certificate. These are:
- Preparation of the administrative and production documents
- Submission of dossiers to the correct licensing authority in Europe.
- Arrangement of plant inspections (note this is only necessary if outside the EU)
- Organization of plant inspections by the licensing authority
- Procurement of the inspection report and issuance of the GMP cert
- Obtaining a GMP certificate
Obtain Global Class GMP Advice And Assistance
While it is far from all we do, one of the benefits of ECA membership is connection to best-in-class GMP experts, auditors and other qualified persons who can help guide your certification and qualification strategies from the beginning of project planning. It is never too early to start to plan for GMP.
Photo Credit: Joshua Coleman, Unsplash