Read on for insight and guidance for the vitally important topic of preventing, eliminating, or reducing microbial growth in cannabis edibles and packaging.
It all starts with the HACCP (Hazard Analysis Critical Control Point) Principles. Gather your team to share the five preliminary steps of HACCP and develop a plan (figure 1). This management system was launched by Pillsbury along with NASA and the U.S. Army for food safety in space exploration in the 1960’s. Quality, safety and efficacy is obtainable and sustainable with the HACCP discipline.
The objective is to PREVENT packaging from being a failure point and inhibit microbial growth in edible products. We know moisture (water activity), temperature, pH, and oxygen levels are primary microbial growth drivers.
HACCP is an asset, not an expense. Food is medicine for some, and cannabis products are medicine for many. Resin cannabis products (RCP) must be safe, consistent, and reliable products continuously. To generate those results, learn the HACCP mindset. Practice being an advocate with HACCP discipline displaying the actions written in the programs. It’s a system for cannabis safety that encourages operations to have Emergency and Business Continuity plans before disruptive events occur, e.g., natural disasters, pandemics, etc.
Resin cannabis product – Any product, whether finished or a work in progress, containing or comprised of cannabis flowers or resins or both and includes, but is not limited to, the cannabis flowers and resins themselves, extracts/concentrates/derivatives thereof, and preparations therefrom.
And can be further classified as Adult-Use or Medicinal-Use and subclassified as Topical-Use.
Creating such a plan is important because exposure to microbes may result in allergic symptoms such as sneezing, coughing, wheezing, nasal congestion, and watery or itchy eyes. Consumers using cannabis products as medicine, such as cancer patients on chemotherapy, are even more susceptible to harm caused by microbes. Thus, it is critical to ensure your products do not have microbial growth.
Effective HACCP management system ensures control. Empower your team through education and training on discipline of HACCP. Take the infused gummy recall from February 2021 as an example where cross-contamination, improper employee hygiene, and package permeability were failure points that led to loss of control. Lack of control during transport of the initially sterile packaging also contributes to contamination. Personal clothing worn by team members or visitors are also known sources of pathogenic fungus.
Best practice is to address preventive controls and reducing/mitigating risks. For example, consider installing two-way humidistatic control devices in packaging, such as desiccant packs, to maintain water activity (Aw) in acceptable ranges to mitigate microbial growth. Reducing moisture prevents powdery mildew caused by Golovinomyces Cichoracearum (figure 2).
A great resource to mitigate risks can be found in the ASTM D37; Standard Guide for Cleaning and Disinfection at a Cannabis Cultivation Center; Aw ASTM Standards for Cannabis Flower: D8196 – Standard Practice for Determining Water Activity in Cannabis Flower; and D8197 – Standard Specification for Maintaining Acceptable Water Activity Range for Dry Cannabis Flower.
Sanitary environments are critical from seed to sale.
Figure 2, Right. Powdery mildew development on leaves, stems, and flower buds of Cannabis sativa, caused by Golovinomyces cichoracearum. 2
Use the principles of HACCP to guide and maintain the integrity of your work. Each principle builds on the next to create a solid foundation to build and operate a safe and consistent management system. Establish storage conditions in your control and transport; determine the temperature and humidity for each product type (gummies do not tolerate heat, and certain ingredients are sensitive to humidity which could change the potency). This includes evaluating the stability of each of the ingredients when in final product form (how long do they remain potent).
Depending on the ingredients used, i.e., the formulation, gummies can take on or reject water. Most typically let out the water, then that water has nowhere to go (trapped in the packaging), and the product molds. This is why commercially produced gummies are coated in wax, literally to trap the water inside the product. Inadequate gummy formulations lead to water permeability; change in cannabinoid content is the least of the concerns.
General chapter 659 on Packaging and Storage requirements published by the USP (United States Pharmacopeia and the National Formulary, USP–NF)is a great resource. Though not all cannabis products may be for the medical market, using the standards of excellence from the USP is the best way to minimize product failure and help ensure consumer safety. Packaging 659 states that packaging materials must not interact physically or chemically with a packaged article in a manner that causes its safety, identity, strength, quality, or purity to fail to conform to established requirements.
Empower your cross-functional team to apply and implement HACCP through your organization. In doing so, you will have the discipline and tools to mitigate risks and prevent costly downtime. Your consumers benefit by having safer, consistent, and quality products. Finally, collect the data and share the story. We all need to drive improvement and produce safe consistent products for our consumers. HACCP systems are a tried-and-true tool to achieve this.
Please note that prerequisite programs such as current Good Manufacturing Practices (cGMPs) are an essential foundation for the development and implementation of successful HACCP plans. This article is intended to level up your current manufacturing processes and mitigate your exposure to potential recall or unsafe products in the marketplace.
In our last article, we discussed the benefits of Good Manufacturing Practices as a means to increase productivity, efficiency, and to drive accountability within an organization. With cannabis and hemp businesses negatively impacted by the ongoing COVID-19 pandemic, tight budgets are even tighter and existing room for errors are tighter than ever. As we begin to carefully rise out of the pandemic, failing to address recurring errors and inefficiencies will be catastrophic. In this follow up article, we dive into a few key systems that make up a GMP facility that you can get started on regardless of whether you are at home or on-site.
Internal (Self) Auditing
Even the most thorough and diligent people make mistakes or forget something from time to time. When you have a business that requires multiple people to make it run, the chances of a mistake increase exponentially. Left unchecked, this can result in catastrophic issues such as inventory reconciliation issues, customer dissatisfaction, product nonconformities, recalls, and even lawsuits. An internal audit program utilizes checklists to periodically conduct independent reviews of all operational areas at predefined intervals. Non-conformances are identified, and corrective action plans are implemented. This best practice is not only a GMP requirement but drives continuous improvement within your organization, ensuring:
List out all functional areas
Generate a matrix to establish the frequency of auditing for each functional area (we recommend every functional area be audited at least once per year – you can spread the auditing workload out over a calendar year rather than doing a full business audit once a year).
Conduct reviews of relevant procedures, documents, and records within those areas
Document the findings (including non-conformities)
Develop corrective action plans with the functional area manager to reconcile these non-conformities
Establish a timeline for closeout
Verify the effectiveness of the corrective action by conducting a spot audit 30-days later
Supplier Management
Did you encounter new challenges with the ability of your existing suppliers to provide you with the quality and timeliness of your raw materials, parts, or ingredients for your operation? Supplier management is a key component of a GMP program and ensures that you are able to deliver on your promises to the final client, be it the customer/patient, or another business in the supply chain. Items to include in a supplier management program include:
A Vendor Qualification Form
Quality Agreements
Right to Audit
Terms and conditions regarding product quality (specifications), and % of on-time performance
Documentation – upon delivery and retained over time
Review your existing contracts and supplier program. Don’t have a formal program in place? Get one started now based on existing relationships and their frameworks, and enjoy the benefits of this program as the economy slowly reopens.
Document Control
Do you have a list of all procedures, forms, and record books? Are they all stored in one binder in the Compliance office or do personnel have access via an electronic Document Management System. How do you ensure when a revision to a document is made that the old one is removed from circulation and not accidentally used by an employee? Document control is a pesky activity that many see as an administrative burden. However, discovering that a new formulation recipe was not being followed by a few employees because they were still using an outdated copy of the procedure for the last 3 months will justify any administrative burden and then some. Fortunately, being the year 2020, affordable electronic systems exist to streamline the process of effectively documenting and communicating all changes to relevant personnel, keeping your business compliant and operating efficiently.
Cleaning and Sanitation Validation
It is likely you increased your cleaning and sanitation regiment in light of COVID-19. How will you know when it is appropriate to scale back to pre-COVID regimens? Do you have any evidence that your prior cleaning and sanitation procedure was effective? Many companies are surprised to hear that their procedures are grossly ineffective. In one example, a company required personnel to wear Crocs in the ‘clean’ production areas. They also wore copious amounts of PPE (fresh lab gown and pants, hair nets, face shields) any time they went into a cultivation room. However, they suffered from significant pest outbreaks that seemed to spread from room-to-room with ease. They even had sticky mats outside of every room. The problem? The Crocs! A simple ATP test revealed bioburden levels that would make a college football port-o-potty seem clean. They were able to reduce their PPE levels by reorganizing workflows and periodically disinfecting the crocs, and their pest outbreaks disappeared within 4 weeks!
The cost – a few hundred dollars in testing for pathogens every week as part of their cleaning and sanitation program. By validating their results (running multiple tests and coming up with the same non-detect result) they were confident that their processes were effective (or as we call it in the GMP world – Validated).
Risk Management and Business Continuity
This final one is not an explicit GMP requirement, but, when built into your overall Quality System can provide you with quantifiable benefits. One of the other business disruptions that became evident in the COVID-19 era was how many companies did not have an effective Workplace Crisis Management Plan in place. Along with the GMP audit process it is recommended to review and update business continuity plans. What was learned during COVID-19? Where are gaps in the chain of communication, processes, and policies? How can we improve our training programs? Taking time to improve and adapt operating procedures will continue to build trust and effectiveness in your business.
Merril Gilbert, Co-Founder and CEO of Trace Trustand A True Dose™ and hGMP™ the first universal independent certification programs for dose accuracy in legal Cannabis and Hemp derived ingestible products. Always at the forefront of emerging trends on the future of food, technology, health and wellness, she leverages 25 years of experience of creative development, operations and investment for everything food and beverage. Current Chair of the NCIA Education Committee.
David Vaillencourt, CEO of The GMP Collective. David and his team at The GMP Collective bring decades of pharmaceutical and food industry best practices to cannabis and hemp. He holds a Master’s Degree, is a Certified Food Systems Auditor and brings a decade of experience in various governmental scientific work. David supports the industry in many ways, including serving as an Officer on ASTM International’s D37 Cannabis Standards Development Committee, participation in NCIA’s Facility Design Committee, and has also developed cannabis training content for college courses.
Webinar Recording: Good Manufacturing Practices in the Age of COVID-19
Tune in to this webinar recording from Wednesday, April 15, 2020. As the realizations of the Coronavirus sink in, one thing is certain – cannabis companies need to be leveraging good manufacturing practices, otherwise known as GMPs. GMPs are the practices required in order to conform to the guidelines recommended by the Food and Drug Administration (FDA). The FDA is the public health agency in the United States that controls the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices. While many companies in cannabis are already following these guidelines, some are not.
This panel explores the GMPs themselves, how companies can become compliant, how GMPs can be amplified to make certain that we are preventing the spread of COVID-19, and whether there are extra precautions that should be taken to keep cannabis consumers safe.
Panelists:
Andrew Kline, Director of Public Policy National Cannabis Industry Association
Haley Brandsgard, Senior Quality and Compliance Manager Mary’s Brands
Alena Rodriguez, Managing Director Rm3 Labs
Trevor Morones, Founder Control Point
Jen Komerda, Quality Assurance Manager Wana Brands
Member Blog: While You Are At Home – Time To Prepare For Achieving GMP Certification
COVID-19 has altered everyone’s day to day life and has put a strain on the healthcare, food, distribution, insurance, and financial industries in ways we did not think possible just a few short months ago. It will be a slow process to get our lives and businesses moving forward. Having Good Manufacturing Processes (GMPs) in place will ensure that your business will rise from this stronger and more profitable, in addition to the trust and safety that it will display to customers.
The lifeblood of your organization starts and ends out on the production floor – whether that is in the greenhouse, the extraction and formulation room, or in packaging. This can be reduced to a series of processes with inputs and outputs. It should go without saying that without product moving through your processes, you have no output and thus no revenue.
Enter Good Manufacturing Practices (GMPs). Don’t confuse GMP as just the latest buzzword in the cannabis and hemp industry. It is a system of best practices that have proven themselves the world over through continuous improvement and refinement for several decades!
These best practices provide significant value to your employees, risk managers, investors, and customers as they enforce your company’s commitment to their safety. While you continue to keep your business afloat during these uncertain times, whether it is from the safety of your home or from the front lines if you are in a market that has recognized cannabis as the essential business NOW is the perfect time to review documents and take the next step to becoming GMP compliant.
Why GMPs for the Cannabis or Hemp Industry?
Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved with any manufacturing production that cannot be eliminated through testing the final product.
GMP covers all aspects of production from the starting materials, premises, and equipment to the training and personal hygiene of staff. Detailed written procedures are essential for each process that could affect the quality and safety of your final product. These are complemented by systems to record and store data, to provide tangible proof that these procedures have been consistently followed – every time a product is made.
If your cultivation, extraction, manufacturing, laboratory, or distribution business is still operating you have probably had to modify your daily operating procedures. This may include implementing staggered schedules, limiting production runs, and providing frontline employees with revised hygiene guidelines and protective gear. Have you updated your standard operating procedures (SOPs) to reflect these changes?
Your SOPs are living breathing documents and are fundamental to every business, and a business built on Good Manufacturing Practices is no exception. To understand the value, let’s ask a few simple questions.
First, have any of these events happened within your business recently?
A change in PPE requirements
New or more stringent sanitation practices
Additional steps for end of day facility closing
New vendors or suppliers of ingredients (hand sanitizer? bleach?)
Employee leave requirements
Assuming the answer is yes to at least one of those questions (and if it isn’t, go back and read it again or call another colleague and ask them), your SOPs need to be updated.
Have you or someone in your organization reviewed your SOPs since any of those changes were made?
If you answered yes, how do you know that? Is there written evidence (a record or log) of this review somewhere?
For many of you, it is likely that someone somewhere performed some level of review, but whether it was documented in a clear traceable manner is another story.
Give Credit Where Credit is Due
It is common that within many organizations, the activities required to establish a robust Quality System, including GMPs largely exist, yet most likely not being documented. Unfortunately, the lack of documentation or poor documentation is nearly just as bad as not having done it in the first place. Why? Because an organization is a large fluid operation with many people moving in different directions. Without a record of changes, this change quickly gets lost in the shuffle.
By now it should be clear that the redundancies and miscommunications from a lack of documenting your activities can quickly multiply. By taking a few minutes to record everything properly provides tangible evidence of the activity (get credit for the work you did!) and will save time and money in the long run!
Now what?
Remember those questions earlier on in the article? Everywhere you had a “No”, go back and make it a “Yes”! And record it. At the end of the day, give yourself a pat on the back. You just conducted your first internal audit! You are well on your way to increasing your operational efficiency, and being able to show the world you care about product safety and quality by demonstrating Good Manufacturing Practices!
Stay tuned for our next post where we will dive deeper into the functional areas and programs that are the core components of a GMP system.
Co-Founder & CEO of TraceTrust and A True Dose™ and hGMP™ the first universal independent certification programs for dose accuracy in legal cannabis and hemp-derived ingestible products. Always at the forefront of emerging trends on the future of food, technology, health and wellness, she leverages 25 years of experience of creative development, operations and investment for everything food and beverage. Current Chair of the NCIA Education Committee.
David and his team at The GMP Collective bring decades of pharmaceutical and food industry best practices to cannabis and hemp. He holds a Master’s Degree, is a Certified Food Systems Auditor, and brings a decade of experience in various governmental scientific work. David supports the industry in many ways, including serving as an Officer on ASTM International’s D37 Cannabis Standards Development Committee, participation in NCIA’s Facility Design Committee, and has also developed cannabis training content for college courses.
Contact the authors to learn more about how your business may benefit from implementing GMPs.
Committee Blog: Facts About Current Good Manufacturing Practices (cGMPs) And Their Role In The Cannabis Industry
Good Manufacturing Practices (GMP) are minimum requirements to ensure that products are created in a manner that ensures they are of consistent quality and safe for their intended use. If a product is found to be produced in a facility that does not meet GMPs, they can be considered adulterated and unsafe. In the U.S., the U.S. Food & Drug Administration (FDA) regulates the manufacture and sale of food and beverages, dietary supplements, pharmaceutical products, and cosmetics by requiring adherence to GMPs. The “c” in cGMP stands for current, meaning that how companies conform to GMPs must continually evolve with the development of new scientific research and industry best practices. Today, the two terms are used interchangeably. While cannabis is not recognized as a legal product at the federal level, federal legalization will inevitably result in the requirement for cannabis producers to conform to cGMPs.
cGMPs can be broken into six major sections (1) Management Commitment, (2) Risk Management, (3) Quality Management Systems, (4) Site & Facility Management, (5) Product Controls, and (6) Staff Training (Figure 1).
Figure 1 Major elements of any system that follows Good Manufacturing Practices
Why are cGMPs important?
cGMPs are important for every industry to ensure manufacturers are producing safe products. A site that isn’t following the minimum requirements for cGMPs in their specific industry is putting the basic well-being of consumers around the world at risk, which the FDA terms adulterated. cGMPs provide assurance that steps within the manufacturing process result in passing final product testing. Final product testing alone is not enough to ensure the safety of consumers. In most cases, final product testing is completed on a small sample batch, so that manufacturers are not wasting the final product on sampling and testing. For example, if the manufacturer is producing 1 million dietary supplements, the manufacturer might only test 100 tablets from that batch. This means that if cGMPs are not being followed and there is no consistency in the safety of producing that product, then some of the products may be safe for consumption, while others may not. This results in product recalls or withdrawals, damage to brand reputation, and lawsuits. A recent study by the Denver Department of Health found that 80% of cannabis products on dispensary shelves failed testing despite passing final batch testing prior to sale.
What do cGMPs include?
Every industry regulated by the FDA has its own guidelines for cGMPs, which are found within Title 21 of the Code of Federal Regulations. Unique differences between cGMP requirements for each industry exist. If your company has multiple product lines that fall into any of these different industries, understanding how these differences will impact you are critical. Figure 2 provides a high-level overview of the major GMP topics that are required by industry.
Figure 2 Summary table of major FDA cGMP regulations by industry sector
Industry Type
Location of primary GMPs within 21 CFR
Food & Edibles
21 CFR 117
Dietary Supplements
21 CFR 111
Pharmaceutical
21 CFR 211
Cosmetics
See Draft Guidance for Cosmetic Good Manufacturing Practices
Figure 3 Table of the major industry types regulated by the FDA and where one can find the major cGMP requirements
Not all GMP topics are referenced in the primary section of the CFRs, which can make it difficult for people who are new to GMPs to ensure they are appropriately prepared. For example, the food and beverage cGMPs (21 CFR 117) does not include packaging and labeling controls, whereas the pharmaceutical cGMPs (21 CFR 211) does include packaging and labeling controls. 21 CFR 101 is home to packaging and labeling statues for the food and beverage industry.
Each sector regulated by the FDA has overlap which contributes to talent acquisition/recruitment from other industries.
THIRD-PARTY cGMP AUDITS
What are Third-Party cGMP Audits?
A third-party cGMP audit is a systematic independent and documented activity in which objective evidence is gathered and assessed to determine if the site’s cGMP system is appropriate and effective. In the 1990’s third-party GMP audits were like an inspection you would receive from the FDA or local health department. This means there was a heavy focus on the building itself and what was happening on the production line during the time of the audit. Nowadays, cGMP audits typically include much more than what is required from the Code of Federal Regulations (CFR). Examples of this include extra requirements for Hazard Analysis Critical Control Points (HACCP) and a much heavier review of documentation to ensure best practices are being followed all the time and not just on the audit day.
Benefits of Using an Experienced and Accredited Certification Body
One thing to keep in mind when considering a third-party cGMP audit is whether or not the audit is accredited. Certification Bodies are accredited (approved) by an Accreditation Body, to ensure their internal procedures and audit processes follow strict guidelines for different audit standards. If approved, the CB gets accredited to that specific audit standard. This along with direct oversight of the audit Scheme Owner and the Accreditation Body ensure that the Certification Body has qualified auditors and that the entire audit process goes through several quality checks before it becomes “final.” In the U.S., the three major accreditation bodies approved to do this are:
WHY SHOULD MY COMPANY RECEIVE A 3rd PARTY cGMP AUDIT?
Unlike the food & beverage, dietary supplement, pharmaceutical, and cosmetics industries, cannabis is federally illegal in the United States. This means there are no federal regulations for cGMPs in the cannabis industry. However, some states, such as Florida, have taken the initiative and implemented requirements to have all cannabis facilities become audited to a cGMP standard before they can receive their license to begin manufacturing.
As the cannabis industry continues to evolve, retailers and others downstream in the supply chain will demand that cannabis manufacturers provide evidence of a certain level of quality and safety in their products. An attestation or certificate from a third-party demonstrating that your facility meets cGMP requirements is an internationally recognized way to provide that evidence and establish trust. Globally, third-party cGMP audits are crucial to maintaining product safety and quality by providing a third set of eyes to verify what is working and what is not. Besides regulatory requirements and customers requiring your facility to get a third-party cGMP audit, there are numerous other benefits to receiving a cGMP audit. Some of these benefits include the following:
Reduction in failed product testing
Improvement of product safety
Improvement of product quality and consistency
Eliminating potential risks and possible recalls
Marketing advantages over competitors who are not audited by a third-party
Improvement to consumer confidence and an increase in brand loyalty
ROADMAP TO cGMP CERTIFICATION
Management Commitment
It is essential to the entire cGMP system to have commitment from top-down. Without this, your site will not receive the resources (e.g. people, equipment, tools, budgets) it needs to implement an effective cGMP system. The culture of an organization requires everyone to practice what is lectured. Simply; Say what you do, do what you say.
Start Preparing Early
Be realistically courteous to the timeline by generating an internal analysis. Using the scheme, the audit will be against, create a list of programs you currently have, and which are missing. Working towards a better score early will provide greater long-term value.
The very first thing you need to do before you start making major changes to your facility or procedures is to identify which GMP standard or standards you intend to meet. With this established, you can select a Certification Body and obtain a copy of the audit form or checklist that they will use to assess you.
Assess Your Current Level of Conformance
Establish an audit team and conduct a thorough assessment of your current organization. If this is new to your organization and staff, it is beneficial to work with a GMP expert that has experience in both cannabis and the cGMP program you are going to be audited against. Review your entire system against the audit checklist and highlight or markup items your site is already doing. This allows you to focus on the things you are missing and close any “gaps”.
Implementation and Teamwork
The preparation of an audit should never rest on the shoulders of one person. Your site should establish a multidisciplinary/interdepartmental team to implement the various tasks based on the findings from your initial assessment. Collaboration is key to successfully preparing for a cGMP audit, especially when timelines set by upper management are very stringent.
Training
Training is essential in preparing for your cGMP audit and business in general. This helps close the gaps between what your safety and quality department has developed and what your front-line employees are applying. All employees should understand what cGMPs are and how it applies to and benefits their daily activities.
Establish Your Internal Audit Program
Conducting internal audits is an effective way to not only prepare for your cGMP audit but to continually improve your organization. Breaking down your entire audit checklist into department or process-specific sections, you can establish the frequency of auditing these bite-sized sections. Should they be reviewed annually, semiannually, quarterly, monthly, or continuously throughout day-to-day operations? Some things, like reviewing your suppliers, may only need to be done annually, while things such as pre-operational inspections should be performed daily. Always use the actual audit checklist to observe your documents and facility to see if there are any gaps. Whenever possible, the person or team conducting the internal audit should never review their own work. Establishing any issues or non-conformances should be noted, evaluated, corrected, and closed out.
Schedule Your Third-Party Audit
A third-party mock audit is the closest thing you can get to an actual audit. This is where a third-party company would come in and evaluate your site to the specific cGMP standards and give a formal report over any deficiencies found during the assessment. This is a great way to test your preparedness before the actual audit.
Address Non-Conformances and Celebrate!
Your auditor will almost certainly identify areas where you are not fully compliant, known as non-conformances. Depending on your level of preparedness, you will hopefully have only a few Minors, but non-conformances can be classified as Major or Critical. You will work with your auditor to establish actions and a timeline to effectively resolve these non-conformances and provide follow up evidence of their closure. After successfully closing out your non-conformances, you will be rewarded with a certificate or attestation. Sit back, relax, celebrate! With a cGMP system in place, the established intervals to audit your system will ensure you have the tools and knowledge to maintain your cGMP status!
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by Trevor Morones, Darwin Mallard, Liz Geisleman
Merril Gilbert, Co-Founder and CEO of 
David Vaillencourt, CEO of 
