Maintaining Regulatory Compliance in the Cannabis Lab
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Government standards and regulations keep the general public safe by ensuring that companies operate using good standard practices and produce high-quality, safe products for general sale.
But for cannabis products, this trusted process breaks down.
Unlike other consumable products in America, cannabis is not regulated by the US Food and Drug Administration (FDA) as the federal government considers it a Schedule 1 controlled substance that has no federally recognized medical benefits and a supposedly high potential for abuse. In the absence of federal oversight, states with legal medical and/or recreational cannabis systems are left to create their own systems, that will safely regulate cannabis products within their borders.
The result is a patchwork of regulation, where rules governing cannabis testing can differ significantly across state lines. Some states focus on mandating specific cannabis testing regimens, such as potent testing and foreign material contamination screening. Whereas others also require labs to achieve official accreditation – such as the ISO/IEC 17025 standard for testing laboratories – in order to comply with their regulations.
Navigating these regulations and working out exactly what is required to comply with local cannabis testing regulations is one of the most complex obstacles to new cannabis testing facilities and existing laboratories, who are looking to pivot into the cannabis testing space.
Typical cannabis testing requirements
Before the compliance practicalities of laboratory environments are covered, it’s important to note that many states require cannabis products to undergo certain mandatory analytical tests. So if a cannabis testing lab is looking to provide a comprehensive service, they must also consider how they will satisfy these testing requirements.
For example, Californian regulations (see Section 19344 of the Business and Professions Code) require licensed testing laboratories to be able to issue certificates of analysis for:
- Potency analysis (including, but not limited to, the cannabinoids THC, THCA, CBD, CBDA, CBG, and CBN)
- Terpene analysis
- Residual solvent analysis
- Foreign material/contamination detection
- Microbial safety testing
Ensuring that your laboratory is equipped to accommodate all of these tests and services is a key step ensuring compliance with state regulations. Most of these tests can be carried out by trained scientific staff using some combination of gas chromatography (GC), mass spectrometry (MS), flame ionization detection (FID), and polymerase chain reaction (PCR) equipment.
A closer look at Good Manufacturing Practice (GMP)
One way that cannabis testing laboratories can prove their excellence is through obtaining a Good Manufacturing Practice (GMP) certification. The major aspects of the GMP requirements cover all manner of systems in the cannabis testing environment, from quality control, to complaints and recall procedures, to personnel and equipment requirements.
While GMP certification may not be strictly required under state or local law, other countries (such as Canada) do require facilities to be compliant with GMPs before allowing the trading of cannabis products. So for many cannabis companies looking to run some sort of import/export operation, a GMP certification is an essential item.
There are many different GMP standards in use in the pharmaceutical industry, such as the American cGMP and the Canadian Guide-104 GMP. But in the cannabis industry, the European Union’s GMP (EU-GMP) has become something of a gold standard for many.
“Many of the countries coming onboard [with new cannabis laws] are in the EU and therefore accepting the EU-GMP standard,” Karina Lahnakoski told Marijuana Business Daily. “It is also likely that meeting the EU-GMP standard means you will conform to GMP production practices put in place by other countries coming online, as the EU standard is very high.”
GMP in the cannabis industry
In addition to proving good lab practice, there may be other motivations for cannabis testing companies to consider pursuing GMP certification. One idea that persists, especially in the American cannabis industry, is the notion that achieving some form of GMP certification might help ‘future-proof’ labs against the changes in regulation that would come with federal legalization.
“While cGMP requirements are currently not often enforced in the cannabis industry, it is assumed by many that the FDA will, at some point, take regulatory responsibility of at least some parts of the industry,” said Shannon Swantek, founder and principal scientist of Enlightened Quality Analytics, to Analytical Cannabis.
Enlightened Quality Analytics provides expert advice and support on regulatory compliance, ISO accreditation, GMP certification, and technical operations to companies working in the cannabis industry.
“GMP systems in other industries generally count on the producers to assume testing by in-house and third-party labs that cover the unique product risk,” Swantek explains. “If the product causes a public health event or is pulled off the shelf by the FDA and does not match the label, there are major consequences to that organization for not doing the proper testing.”
“But the cannabis industry did not start off within this structure, and so the onus here falls on the third-party testing laboratories to assist the industry in helping create the testing schemes necessary for GMP compliance and controlling product risk, such as shelf life studies, combustion and breakdown products, and source material testing.”
How do you get GMP certified?
The first step in becoming GMP certified as a testing facility is to determine a goal and then carry out a gap assessment to govern how far away the goal is. For example, a company might wonder if it wants to pursue cGMP or EU-GMP certification, and from there can begin to assess what changes need to be made to operations to meet the necessary standards. In doing this, it should also become clear exactly how long it will take to reach certification standard, and how expensive these changes might be.
A big part of GMP is keeping accurate and up-to-date documentation of all practices going on in the testing lab. To achieve accreditation, labs are required to update and submit their standard operating procedures (SOPs) – which for a cannabis lab can easily number in the hundreds – to make sure they all contain relevant regulatory references.
Arguably the most complicated part of GMP accreditation is implementing any missing programs into the lab environment. For example, a lab might already have good documentation that describes the sample’s chain-of-custody while it’s in the lab, but it might be missing a stability program made to assess the expiration date of the product once it leaves the lab. It could take well over a year to implement this kind of program from scratch, as the lab would have to minor and re-test a sample regularly over the span of many months to accurately determine a reasonable expiry date on the product.
Once all the necessary documentation and programs have been brought up to scratch, many labs choose to stage a mock inspection ahead of the official GMP inspection from a third-party auditor. Passing a GMP inspection is not guaranteed, but with proper preparation, cannabis testing labs can easily bring their practices in line with GMP standards.
A closer look at ISO accreditation
While GMP certification is a useful yet optional reputation booster for any lab, many states, including California, Massachusetts, and Colorado, are starting to require that cannabis labs obtain official accreditation in order to operate within their borders. Of these states that require accreditation, the vast majority specifically require cannabis testing facilities to attain ISO/IEC 17025 accreditation.
Outside of the states that require it, many testing labs are voluntarily choosing to seek ISO/IEC 17025 accreditation as a way of demonstrating to potential clients that their operations are in line with international laboratory standards.
ISO/IEC accreditation for cannabis testing labs
The International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) are both independent organizations that develop and publish fully consensus-based international standards for a variety of industries.
The ISO/IEC 17025 standard was first published in 1999, subsequently updated in 2005, and most recently in 2017. The standard is widely considered the single-most important benchmark for cannabis testing laboratories, with nearly 70,000 laboratories accredited to ISO/IEC 17025 as of 2017.
“The ISO/IEC 17025 is the international standard of credibility for the laboratory industry,” explains Swantek, who is also a qualified ISO/IEC 17025 auditor.
“It is a general standard that provides good practices in quality management. The keyword in this description is general – [the standard] must meet the needs of every type of laboratory in the world, from in-house pharmaceutical, food, and nutritional supplement company laboratories, to regulated environmental testing laboratories.”
Similarly to the process of becoming GMP certified, the first step in working towards ISO accreditation is identifying a vision for the future. If pursuing ISO accreditation, a lab is probably doing so in order to prove its quality – but that can mean different things to different people. Planning a series of staff meetings or visits from trained consultants on the topic of “quality” can ensure that staff knowledge is all brought to the same level.
It’s also essential to take a look at the current organizational structure of the laboratory. Each staff member should be aware of their own individual roles and how they relate to the overall workflow of the laboratory. Some labs also find it helpful to designate a number of “quality managers” who can concentrate on making sure the lab is up-to-standard and running efficiently.
Staff training courses are also typically recommended, as this knowledge will help lab personnel to properly document and monitor all of the activities going on in the laboratory. Like in GMP certification, ISO accreditation also requires work protocols, such as specific testing methods, to be documented and validated.
Staying in compliance
Achieving GMP certification and ISO/IEC accreditation can be a very complicated process. Because of this, many companies feel the need to hire external consultants who have experience with the regulations and the tasks involved with becoming fully compliant.
This is the sort of clientele that Enlightened Quality Analytics, and other similar industry consulting businesses, exist to support.
“We are in the business of helping our clients achieve and maintain accreditation to international standards,” says Swantek. “We work with their laboratories to ensure accurate data, and to develop testing schemes that reduce their product risk. We can provide all the on-going support and/or training that is needed to maintain the systems we help put in place.”
Consultancy firms can help to provide the personnel training and regulatory advice that can increase the chances of a testing facility passing the final inspection for GMP certification and ISO accreditation. Many also provide quality advice for how companies can continue to stay in compliance with these standards after they have been achieved, and with local regulation.