Europe is the next big-ticket for medicinal cannabis, but it’ll take more than just having the right resources and team in place to make an entrance. The key to accessing this emerging market is having Good Manufacturing Practice (GMP) accreditation. A requirement that all medicinal products come from a GMP accredited manufacturer is one of many strict regulatory measures the European Union has put into place. Their aim is to assure both regulators and consumers that the products are safe, consistent, fit for purpose, and of the highest quality.
As part of our Vitalis educational series, our team of experts recently led a webinar on the process of obtaining a GMP certification for the equipment. In case you missed it, we’ve recapped the most important points to consider.
What is qualification versus validation?
Validation is an act, process, or instance to support or collaborate something on a sound authoritative basis. Qualification is an act or process to assure something complies with some condition, standard, or specific requirements.
Does the Factory Acceptance Test (FAT) include actual extraction performance as performed on the customer like feedstock?
No. The FAT includes running the machine at a minimum and maximum operating parameters with no product. It allows for any issues with the machine to be identified in the absence of the product.
Are all of your gauges also field calibratable for future Performance Qualification?
Yes, all of the sensors and gauges can be calibrated by a qualified professional in the field.
Does re-using and recycling CO2 present any GMP challenges?
Re-using any solvent in a GMP environment does pose a challenge. You must prove that the recycled solvent will not affect the product quality of future batches.
Is there any statement in any of the GMP schemes that define Calibration requirements during the maintenance/life cycle of the equipment?
GMP regulations do not state how often instruments should be recalibrated as every instrument will be different. Manufacturers may provide a recalibration schedule, but it is ultimately up to the customer.
How does the development of Standard Operating Procedures (SOPs) fit into the GMP documentation sphere?
Any task that is done in a GMP environment that affects product quality should have a SOP to support that task. Having a SOP ensures that the task has been evaluated and is done the same way every time.
Does the scope of GMP change based on the stage of the process? For example, does a solvent tank require the same surface finish as an extractor?
They do not necessarily need to have the same surface finish. GMP is a risk-based system. If the risk of microbial or chemical contamination of the surface is high, then a smoother surface would be warranted to allow for easy cleaning. The solvent tank will probably only contain solvent and no product. Depending on the solvent, the surface finish may be rougher as the risk of microbial contamination is low.
Who is responsible for verifying and providing the GMP certification, and is it different per jurisdiction?
Every GMP jurisdiction will have a regulatory authority with inspectors to carry out audits.
Is EU-GMP the most stringent certification of all GMPs?
It is hard to argue who has the most stringent GMP regulations, but the most highly regarded regulations can be found in the US (FDA), the EU, and Japan. Traditionally the FDA has been the largest pharmaceutical manufacturers while the EU and Japan are the largest markets, both bringing with them their own set of mature regulations.
What insight do you have into the validation process for multiple pieces of equipment from different manufacturers?
Each piece of equipment in a GMP environment needs to be validated separately, regardless if they are from the same manufacturer or not. When using multiple manufacturers, the validation effort may be more as each manufacturer may offer differing levels of support and documentation. If you can procure equipment from the same manufacturer, then you only have to deal with one company, which may streamline your validation efforts.
Is EU-GMP easier or more cost-effective for CO2 extraction technologies versus ethanol extraction?
Both can be used for GMP purposes. However, it all depends on the products you are manufacturing, as well as the pre- and post-processing methods required. There are additional infrastructure requirements when using ethanol and getting ethanol of the required grade may be difficult depending on geography.
Are cannabis extractors currently required to be GMP certified in Canada?
Cannabis extractors do not need to be GMP certified in Canada; they must adhere to Good Production Practices (GPP).
Is it possible to operate a GMP certified piece of equipment in a non-GMP certified facility? i.e. can you get validation on the machinery, but not the whole facility?
GMP certification applies to the entire production process, so you can’t have GMP certified equipment in a Non-GMP facility. You can have equipment that is GMP compliant and is validated in a non-GMP facility.
Is it possible to have a fully compliant lab and make dangerous products?
Many common pharmaceutical drugs and foods such as coffee, if consumed in excess, can be toxic and, therefore, dangerous. Most pharmaceutical drugs, if not taken as per the manufacturer's recommendations, can have harmful effects on an individual. Every pharmaceutical drug has to go through an approval process, and part of that is determining the safe dosage. If the advice is not followed, then there could be harm to the consumer, but if the advice is followed, there should be no issues, and the drug can be considered safe.
What if your terpenes are made in a Current Good Manufacturing Practice (cGMP) facility, but you add too much to a cartridge and vape at too high of a temperature?
Take, for example, if terpenes are made in a cGMP facility, but too much was added to the cartridge and vape at too high of a temperature. This has been occurring in the USA due to very lax regulation at the state level on vape cartridges and no regulation at the federal level. Equally, it means the FDA, the agency tasked with protecting consumer safety, cannot. The only way to avoid such a thing is for cannabis to be brought within the scope of the FDA where they can regulate the vape cartridge contents and set limits.
cGMP is one part of consumer safety, but does that mean it is necessarily assurance of its safety?
GMP is meant to protect consumer safety during the manufacturing process of the product. GMP has nothing to do with whether the product itself is safe. Product safety is covered when a pharmaceutical drug is submitted to the FDA for approval and is what clinical trials establish. GMP will guarantee that the product has been manufactured consistently and to the highest possible standards.
Interested in learning more about GMP certification? Speak to one of our experts today.