Cannabis Needs Supplier Quality Agreements

Consumers often assume the product they are buying is, for all intents and purposes, what is labeled or described on the packaging. They make the purchase without second thought on what is being purchased. It is usually a fair assumption, and due to the innocuous nature of most products, the buyer is not out anything more than The time and frustration of sending the product back to the purchasing location. Consumer goods generally come with a guarantee to ensure that the consumer can will be satisfied with the product, or the manufacturer with replace or refund the product at their own expense. That is all well and good for the consumer, but what about business to business transaction where the buyer is another business?

In these cases the buyer would be out more than just time and frustration as the product purchased could cause a loss of income if the product is an ingredient for the buyer’s product line. For example, a nutrient supplier mixing up product lines and cannabis cultivator applying a feeding cycle of micro nutrients while assuming low concentration and subsequently burning up the entire crop. In this case there would be lost revenue due to loss of plants and lost time spent to this stage of growth, All of which must be restarted – both time and money lost.

In the worst case, a consumer of cannabis products like vape cartridges or tinctures is harmed from unsterilized containers due to poor handling practices or sterilization techniques. This would cause patients or consumers to shy away from the manufacturer all together. In these cases, the brand is harmed and those losses are hard to quantify. However, irreparable damage can be assured. So how do businesses protect themselves when buying from another manufacturer? How do these companies ensure that what they are buying is what they are getting? After all, the livelihood of their products and overall brand of their company is at stake.

Supplier Quality Agreements and vendor audits make these assurances so that business to business transaction are protected by more than just a replacement or refund. A supplier quality agreement is a contract between a supplier and a buyer for specific products that are being purchased. This contract details all aspects of the purchase, such as packaging quantities and labeling of the product and its contents, to the specifications that each shipment or lot of product must meet for the product to be accepted by the buyer. The agreement spells out the testing requirements and reporting of data that the buyer receives each time a purchase is made for a quantity of product. This ensures that each order must meet the specifications set by the buyer, and not the assumed quality of the manufacturer.

What sets these agreements apart from the normal consumer “guarantee” is the fact that these contracts can hold the manufacturer liable for defective product that is purchased and lost revenue due to the poor quality of the product. Supplier quality agreements protect the company’s best interests and transfer a part of the risk from the buyer to the supplier. It is worth noting that having a means of verifying the testing results is a best practice. This is a sure fire way to eliminate all doubts about the contents of the product.

At the end of the day, supplier quality agreements will allow the cannabis industry to concentrate on what they do best. The company is protected from losses in revenue and time spend while the consumer focus of health and safety is maintained. Let the trusted quality professionals at Orion help you navigate the complexities of supplier quality agreements so that you can spend less time worrying about your supplier and more time on your final products. Contact us today at Orion GMP Solutions or by email at info@oriongmp.com to get started on your supplier agreements.

Oregon Cannabis Quality Gets A Boost

Starting August 30, 2017, every batch of usable marijuana must be tested directly for pesticides according to the Oregon Health Authority’s testing rules in order to be compliant. This includes product that was sampled prior to August 30.

The state of Oregon is continuing to lead in terms of standardizing quality in the cannabis industry. As of August 30th, cannabis cultivators and producers test and qualify 100% of batches going to dispensaries from an ORELAP (Oregon Laboratory Accreditation Program) accredited testing laboratory. These labs undergo a biennial review from the state to ensure that the laboratory has procedures in place that adhere to internationally recognized standards.

Raw flower and concentrates including edibles must pass testing for pesticides, water activity and moisture content, potency of cannabinoid compounds, and microbiological contamination. Oregon Health Authority has created an overview of the testing and reporting requirements.

Before the mandate was in place, only 30% of batches required testing before approval to be sold in local dispensaries. In a bulletin published this week, cannabis organizations will be required to test all harvest and production batches of cannabis before going to market.

Initially, the reduced testing requirements were the consequence of a limited number of accredited testing laboratories. Currently, for a lab to be certified to test cannabis or its products it needed to be accredited by the ORELAB and licensed by the OLCC. The number of labs has increased from 5 to 10 since the initial requirements.

Since last year, there have been 3 instances of recalls in the state of Oregon. Two recalls were initiated by the Oregon Health Authority and 1 by the Oregon Liquor Control Commission. In our article, The Downfall of a Recall, we identified how all of these instances could be avoided with the proper quality systems in place.

The increase in inspections definitely has the patients and consumers best interests at heart but these inspections are simply filtering out the defective products. Quality can never be inspected into a product, rather it must be inherently incorporating into the production process. Oregon and the rest of the country must continue to push for standardization of the industry and regulation for the manufacture of cannabis and cannabis products.

To learn more about quality by design and creating processes that bring inherent quality to your products contact us at info@oriongmp.com or visit our website for more information.

Cannabis Testing Laboratory Guidelines

This might not sound savory to the manufacturing side, but often, there is high variation in the manufacturer’s product.

HempHacker and Orion GMP Solutions firmly believe that testing for product quality is useless when we are talking about GMP Cannabis. It must first be engineered into the product – Quality by Design, to be specific. Testing laboratories serve an important function in the industry. They have many different sample types, and their work must be both accurate and precise.

With multiple sample types (e.g edibles, raw flowers, solid and liquid extracts, and infused beverages), the analytical chemists of the cannabis industry have their work cut out for them. In GMP Cannabis Manufacturing, all the testing is done in-house. This is called in-process testing. In-process testings is an activity that measures your product’s quality attributes as it is being processed.

Several important points come up in these guidelines. When to test. What to test. How to test. These are the essential activities in a GMP Cannabis Testing Facility. In the Cannabis Industry 2.0 (i.e. GMP Cannabis), all laboratory testing will be done in-house, and it will not be hindered by restrictive legislation. Validated and repeatable test methods are mandatory for the analytical laboratory to provide consistent results. This is an important point, should be considered by every cannabis manufacturer.

This might not sound savory to the manufacturing side, but often, there is high variation in the manufacturer’s product. Think about it – how many different structures are there on the plant; how many different light angles are hitting those different structures, how many different samples were taken from the plant… There is a lot to think about, and those are only a few variables.

Take a look at this 36 page PDF developed for New Mexico Cannabis Testing Facilities. It describes everything you would ever want to know about a testing facility down to how they should document their work, to how they actually do their work.

While these guidelines do not explain all aspects of a GMP Cannabis In-Process Testing Laboratory, they do describe the activities well.

Standardizing Cannabis with ASTM D37

In 1996 California introduced cannabis for medicinal use, opening the doorway to legalization in the United States. Many other countries and cultures have recognized cannabis for its therapeutic properties. and Now, more than a decade into the twenty-first century, has the US began to accept this notion as well.

Cannabis is now the fastest growing industry in the United States with sales slated for $7 billion, more than a 25% increase from 2016. A poll by Gallup shows that cannabis approval is up to 60% of the American public in 2016 which is 50% higher than 2011. In 2012 Colorado and Washington State became the first states to have recreationally legal cannabis for consumption by those 21 years of age or older.

By 2017 states across the union have recognized cannabis for medicinal use. Currently, 29 states have some form of medicinal cannabis laws in effect with 8 states and the District of Columbia being out right legalized for recreational use.

The federal government still has cannabis listed as an illegal schedule I substance with no oversight by the FDA for regulation. With a serious need emerging for regulation, stakeholders in the budding cannabis industry turned to ASTM International in 2015 for a committee to be formed to create standards. ASTM being an internationally recognized body of professionals that lead the way in creation of standards for industries throughout the world for basically every facet of manufacturing, finally accepted the task in 2017 and created D37 the committee on cannabis. For stakeholders in the industry this was a huge step forward in the recognition of cannabis and its legitimacy as a therapeutic drug with widespread medicinal use.

D37 is the officially recognized committee on cannabis with the inaugural meeting on June 11-12, 2017 in Toronto, Canada. The committee is composed six subcommittees to cover all aspects of manufacture of cannabis which was agreed upon during the meeting to vote and create the committee at ASTM headquarters.

The six subcommittees cover indoor and outdoor horticulture and agriculture, quality management systems, laboratory, processing and handling, security and transportation, and personnel training, assessment, and credentialing. Each subcommittee is chaired by a leader in each respective field.

Those involved in the inaugural meeting all agreed that this is a pivotal point in the industry and the upmost care shall be taken in the development of these standards. Careful consideration will be placed on each and every standard and all stakeholders see this committee as the prime example of what cannabis will be in the next decade.

ASTM has chosen to lead the way in bringing cannabis from the taboo underground into the forefront of horticulture manufacturing. D37 will bring standardization into a medicine that so many already desperately depend on and a medicine that so many more need. ASTM has recognized the flaws in an industry that most have a difficult time acknowledging as a legitimate medicine but understands the more information that is available the more likely it is to be accepted. Cannabis is no longer in basements and closets but controlled in multi-million dollar state of the art greenhouses. This will be the medicine of the 21st century and eliminate the dependence on opioids that are destroying so many lives. Stakeholders of the industry see this as the way in to the future and the help so many need.

Contact Us.

Are you interested in participating in ASTM International D37 Cannabis Standards Committee? Send us an email and we will send you a personal invitation to the committee.

Downfall of a Recall

Oregon’s recreational cannabis market experienced its first recall of cannabis this month after cannabis flower containing high levels of pyrethrin was sold to the public. The Oregon Liquor Control Commission (OLCC) issued the first recall of recreational cannabis after BUDS 4 U notified the commission of contaminated cannabis flower. Samples of Blue Magoo failed for the chemical pyrethrin when tested at GreenHaus Analytical Labs. Several breakdowns of the quality system in each tier of the distribution system occurred for this recall to take place.

The root cause of the recall stemmed from the application of pyrethrin. This chemical is a widely used insecticide for soft-bodied insects and is considered to have low acute toxicity in humans or mammals. The fact it was applied indicates a need to eliminate insects. In no case should a pesticide be applied without cause. If it is necessary to eliminate pests, it is the responsibility of management to minimize the introduction of pesticides that will adequately eliminate the pest and preserve the quality of the cannabis.

Insects are foreign bodies that should not be present in cultivation operations when proper quality management systems (QMS) are in place and strictly enforced by all employees of the operation. Proper quarantine and Quality Control (QC) testing of raw materials such as grow mediums or nutrients should eliminate the presence of foreign bodies. Any outside materials that introduced to the cultivation room or greenhouse should be quarantined before being used and be required to meet quality assurance specifications that ensure contamination risk is eliminated.

Proper environmental controls ensure that the physical cultivation areas are maintained in a way to eliminate the introduction of pests. Requiring employees to change from personal clothing reduces the probability of inadvertently introducing pests from outside environments. Insect nets on regularly inspected external vents or air circulation systems reduces the chance for introduction of infestation into the cultivation areas. Regular inspection of physical structure for damage or deterioration reduces risks of outside pests being introduced to the operation. The preventative measures listed offer some examples of what can be done to eliminate the introduction of pests into cultivation areas, however sanitization between harvest batches must be performed as a primary preventative measure. This ensures that the room and all equipment will not be the source of contamination.

From a QMS point of view, the most serious breakdown of process is the release of cannabis that was not verified by approval of the operation’s quality assurance department. This harvest lot or batch should have been segregated and properly quarantined until specifications were met. It is the responsibility of quality assurance to certify that all products have met the entirety of the specifications, including pesticide residue, before releasing for shipment. Approval and verification of meeting product specifications before batch release is the most vital duty of any quality assurance department.

Not only was the batch released from the cultivation facility without being properly certified, but the distributor was careless enough to release the product to a dispensary without completing their own quality assurance checks to ensure the products in their control were properly tested and that all specifications were met. The dispensary is also partially to blame, but it should also be praised considering it initiated the notification to the OLCC and started the recall process. If proper checks were in place through the QMS system this would have been caught and the public’s safety would not have been at risk.

QMS only works if every aspect is strictly enforced and followed to the letter. Each operation has the responsibility to verify all specifications and checks are made when the health and safety of the public is at risk. Adherence and certification to the FOCUS Cannabis Cultivation Standard is an easy route that cultivation operations can take to ensure all products meet specifications. Recalls can be the quick end of a company, and meeting the guidelines of this certification is one way to ensure that business will continue to prosper. FOCUS Standards are set by leading experts in the fields of quality management and can help ensure the safety and health of all those receiving cannabis related products.

References:

Gunasekara, Amrith S. “Environmental Fate of Pyrethrins.” Environmental Monitoring Branch, Department of Pesticide Regulation, Sacramento, CA, 2004.
https://www.oregon.gov/ODA/programs/Pesticides/Pages/CannabisPesticides.aspx
https://www.oregon.gov/ODA/shared/Documents/Publications/PesticidesPARC/GuidelistPesticideCannabis.pdf

GMP Cannabis simplified into 11 steps

Sometimes it’s best to take a step back, and explain basic concepts of the bigger picture – to take a look at the forest instead of just the trees. Good Manufacturing Practices (GMPs) are complicated systems that assure customer safety. Despite being complicated, you can break them down to a simplified concept of what they are, why they exist, and what it looks like for an operator or technician executing a Standard Operating Procedure (SOP).

What is GMP?

GMP stands for Good Manufacturing Practices. It is also commonly referred to as cGMP, meaning that it is the “current Good Manufacturing Practice” that meets GMP requirements as they are currently regulated. They are the set of regulations that describe all of the operations required to call a drug product, a GMP certified product. Any drug you buy at the pharmacy is produced under GMP conditions.

Why are there GMP regulations?

GMP’s are a way to ensure the public’s safety for manufactured drugs, in order to prevent public health crises. It helps prevent the distribution of adulterated drugs, due to poor manufacturing practices, from reaching consumers that whose health could potentially be harmed.

For example, there was a time before GMPs, where a manufacture could substitute whatever they wanted into their “miracle elixers” that were good for soothing all aches and pains. There was no basis for their efficacy, and the ingredients were completely unregulated. This all changed around 1906 when Upton Sinclair wrote “The Jungle,” where he described the filthy and unsanitary conditions of meat packing plants in Chicago. This completely changed how people thought about how things are manufactured.

What does it mean to operate under Good Manufacturing Practices?

Things have changed since the early 1900’s, and we now have processes in place to make sure that no drug or food substance goes out the door of a factory without having close control over the process. There are many concepts packed into an SOP, and many systems that all work together to make the process work.

So, “from the ground up,” here’s what is looks like when a technician or operator works through a GMP process using their SOP’s. Imagine a technician producing and extract using a Supercritical CO2 process or a Cannabis chef producing an edible with a purified extract.

Obtain the proper and current Standard Operating Procedure (SOP) before starting the job. The SOP will guide the technician through the procedure step-by-step, greatly reducing the chance of operator error.
Thoroughly read through the SOP before starting to make sure that nothing has changed for the procedure, and that the right procedure is being used for the right starting materials.
Follow the instructions exactly, and do not change them or deviate from them.
Work accurately and precisely, paying close attention to the details of each step.
Prevent any contamination or mix-up of materials. Do not have two separate batches of raw materials of in-process materials in the same are without being labeled.
Make sure that no products are mislabeled.
Use equipment that’s been cleaned, calibrated, and is the right tool for the job. All equipment should be well maintained and ready to use. If something is not working, it should be labeled “out of service” until it’s ready for use.
Document your work as it is being done, with initials and dates on the SOP for each step.
Keep your workspace clutter free and clean.
Any documented work may not be destroyed – it can be corrected, but never discard it.
If anything does not go according to the SOP, it must be reported to direct supervisors and the deviation must be documented and analyzed for any risks posed to the end user.

These are the most general guidelines for what GMP looks like in practice. While GMPs are a new concept to the recreational and medical cannabis industry, they’re not new to the pharmaceutical industry. It will take time for the industry to catch up, but it’s not hard to do once a company commits to a culture of quality management systems and cGMPs.

If you have more questions, check out www.oriongmp.com and get a free consultation on putting together your Cannabis related Good Manufacturing Practices and Quality Manufacturing Systems.

18 GMP Cannabis definitions you need to know

The Code of Federal Regulations Title 21, Part 210 is dry reading, but it’s necessary for the cannabis industry to digest. Understanding these regulations, despite their dry nature, is the job of the Quality Assurance unit. In fact, it’s optimal that everyone involved in cGMPs is very aware and familiar with this documentation.

For the sake of this writing, my aim is to inform quality assurance (QA) and quality control (QC) personnel of what they need to know. This is a good place to start. You must understand the following definitions in order to read further into the literature of Good Manufacturing Practices.

Code of Federal Regulations Title 21, Part 210 – Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs

The 21 CFR 210 and 211 only describe the minimum current good manufacturing practices.

The 21 CFR describes the minimum methods, facilities, and controls that need to be in place for manufacturing, processing, packing, and/or holding any drug product. The main goal is to make sure that drugs are manufactured to the specifications they claim to have – it ensures:

Safety
Identity and strength
Quality and purity characteristics

As usual, there’s a consequence for not following the rules, which can be very costly. If it’s found that a company manufacturing under cGMPs is not complying with the 21 CFR, they may:

Determine the drug is adulterated
Hold the person responsible who was in charge of the process

When your company is found to be violating the 21 CFR, you might get a publicly published 483 warning letter that will say something along the lines of:

“You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.”

Right now, cGMPs for the cannabis industry are in their infancy. When the FDA is regulating the industry, it will be a different story.

Definitions

When you fully understand these terms, you will have a much easier time understanding the 21 CFR part 211. It’s the baseline of information that sets the stage for everything that’s to come. Take warning though – these are complicated definitions, and often require a background in chemistry or the sciences to fully understand.

Some definitions will be followed by an explanation tying it into terms related to the cannabis industry, as necessary.

Batch – a specific quantity of a drug or other material that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture.

This could be a batch of plants that finished their flowering period at the same time, and were harvested at the same time. Alternatively, it could be the finished extract that was produced by one cycle of a CO2 or hydrocarbon extraction system.

Component – any ingredient intended for use in the manufacture of a drug product, including those that may not appear in the final drug product.

This could be the CO2 or butane used in an extraction.

Drug Product – a finished dosage form, for example, tablet, capsule, solution, etc., that contains an active drug ingredient generally, but not necessarily, in association with inactive ingredients. The term also includes a finished dosage form that does not contain an active ingredient but is intended to be used as a placebo.

This could be flowers that have been fully processed to their dried and cured form, ready for use. It could also be an extract that has been fully purged, packaged, and labeled, ready for use.

Fiber – any particulate contaminant with a length at least 3X greater than its width.

Nonfiber releasing filter – any filter, which after appropriate pretreatment such as washing or flushing, will not release fibers into the component or drug product that is being filtered.

Active ingredient – any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or other animals. The term includes those components that may undergo chemical change in the manufacture of the drug product and be present in the drug product in a modified form intended to furnish the specified activity or effect.

In the case of cannabis, this would be all the cannabinoids that are present in the final product. Cannabis is tricky in that its final forms are usually a mixture of cannabinoids, and not pure product. All together, the mixture of cannabinoids can be considered the active ingredient.

Inactive ingredient – any component other than an active ingredient.

In the case of cannabis flowers, it would be everything but for the cannabinoids. In the case of an extract, there can be waxes and other lipids that are present with the active ingredient.

In-process material – any material fabricated, compounded, blended, or derived by chemical reaction that is produced for, and used in, the preparation of the drug product.

In general, there are purification steps involved in producing cannabis products, and relatively few chemical reactions.

Lot – a batch, or a specific identified portion of a batch, having uniform character and quality within specified limits; or, in the case of a drug product produced by continuous process, it is a specific identified amount produced in a unit of time or quantity in a manner that assures its having uniform character and quality within specified limits.

Similar to a batch, but is the result of a continuous process. Therefore, a lot would be the packaged components from, for example, 100 bottles filled with cannabis tinctures. The tinctures would be filled in a continuous process and all 100 would be filled in a specific identified amount of time or quantity.

Lot number, control number, or batch number – any distinctive combination of letters, numbers, or symbols, or any combination of them, from which the complete history of the manufacture, processing, packing, holding, and distribution of a batch or lot of drug product or other material can be determined.

This is the identifying number of a lot or batch. It’s a locally produced number that’s used to track all activity that was associated with manufacturing a drug substance.

Manufacture, processing, packing, or holding of a drug product – includes packaging, labeling operations, testing, and quality control of drug products.

Quality control unit – any person or organizational element designated by the firm to be responsible for the duties relating to quality control.

Strength

The concentration of the drug substance (e.g. weight/weight, weight/volume, or the unit dose/volume basis).
The potency, i.e., the therapeutic activity of the drug product as indicated by appropriate laboratory tests or by adequately developed and controlled clinical data (e.g. expressed in terms of units by reference to a standard).

Theoretical yield – the quantity that would be produced at any appropriate phase of manufacture, processing, or packing of a particular drug product, based upon the quantity of components to be used, in the absence of any loss or error in actual production.

Actual yield – the quantity that is actually produced at any appropriate phase of manufacture, processing, or packing of a particular drug product.

Percentage of theoretical yield – the ratio of the actual yield (at any appropriate phase of manufacture, processing, or packing of a particular drug product) to the theoretical yield (at the same phase), stated as a percentage.

Acceptance criteria – the product specifications and acceptance/rejection criteria, such as acceptable quality level and unacceptable quality level, with an associated sampling plan, that are necessary for making a decision to accept or reject a lot or batch (or any other convenient subgroups of manufactured units).

Representative sample – a sample that consists of a number of units that are drawn based on rational criteria such as random sampling and intended to assure that the sample accurately portrays the material being sampled.

If you have more questions, check out www.oriongmp.com and get a free consultation on putting together your Cannabis related Good Manufacturing Practices and Quality Manufacturing Systems.

GMP Cannabis vs. Extraction content on HempHacker

Last week I sent out a survey to subscribers on the HempHacker email list. The goal was to find what content interests readers the most. The numbers and comments speak for themselves. Overall, everyone loves actionable content, but they would also like to see more blog posts about what’s going on at HempHacker.

The people’s choice is extraction content. If the people will have it, it shall be done. However, I am looking for an experienced writer and cannabis alchemist to join the HempHacker team to write for the crowd. My time is being placed mostly on Good Manufacturing Practices (GMP) consulting lately, and I haven’t been able to focus on extraction content.

I received some very helpful constructive criticism, which I greatly appreciate. It helps me understand how I could do my job better. It’s slightly difficult to scale it for all situations since there are different variables for each system, but I understand the need for specific parameters in doing extractions. I will work to improve this.

64% want more extraction content

New extraction techniques on the market
- Wiped film evaporation
- Short path distillation
Specific parameters for supercritical extractions – i.e. useable parameters
- Amounts to be extracted
- Solvents used
- Temperatures
- Pressures
Solventless extractions
SFE vs BHO comparisons

36% want more GMP Cannabis related content

How to establish GMP systems in your facility
GMP Training
Good Documentation Practices (GDP)
Quality Assurance (QA) and Quality Control (QC) Practices

While I understand the majority want to see more extraction content, GMP consulting pays the bills, and is my primary focus. I really hope that the GMP Cannabis content will also be useful to people doing extractions. It is the definite future of the industry, and I would like to help everyone learn the practices before the FDA regulates the production and processing of cannabis and its extracts.

Thank you to everyone who participated in the survey. Your feedback is very useful to me. As usual, you have an open line of communication to me at andrew@hemphacker.com.

-Andrew

Compliance vs. Good Manufacturing Practices

Just to clarify, there is a difference between Compliance and Good Manufacturing Practices (GMPs). To put it simply, Compliance covers the laws that allow a company to manufacture cannabis and its products, while GMPs provide a framework for how you do it.

Compliance is presently defined as the state by state rules for manufacturing cannabis and cannabis products. It covers the regulations, required transparency, laws, policies, requirements, and standards for manufacturing cannabis. This sets the legal framework for how businesses in their respective states can operate.

Good Manufacturing Practices, on the other hand, are guidelines that come from the Food and Drug Administration and the International Conference on Harmonization. Both provide the requirements for a pharmaceutical manufacturing operation to produce drugs that will be ingested by human beings. They set the operational framework for how to manufacture drugs that are safe for human consumption.

There are also some similarities. Both Compliance and GMPs can have Standard Operating Procedures (SOPs). SOPs are simply the documentation of any process that a company does. They range from simple to complicated. It can be an SOP for sweeping the floors, or an SOP for a 32 step organic chemistry synthesis of tetrahydrocannabinol.

Compliance is without a doubt, the most important first step to establishing your business. Without it, you can face serious legal consequences. Establish your company with a trusted attorney who specializes in compliance, and start manufacturing with peace of mind.

GMPs are the next best step to make your business stand out above the competition – being a GMP Certified facility creates a huge differentiation in your product. With a well defined GMP system in place, you can track improvements to your product over time using the scientific method, ensure consumer safety, and have fully traceable processes. Overall, it’s a win-win adaptation to your business because you improve your processes (and chances to be bought out) and you improve product safety and quality for the consumer (sell more product).

If you have more questions, check out www.oriongmp.com and get a free consultation on putting together your Cannabis related Good Manufacturing Practices and Quality Manufacturing Systems.

Validating SOPs for GMP Cannabis

The objective of validating a procedure is to demonstrate that the procedure is suitable for its intended purpose. This extends to all SOPs. They must be validated to prove that they accomplish their purpose. There are many different processes that can be validated in pharmaceutical operations. Some examples include, but are not limited to, process chemistry, analytical testing, lab facilities, cleaning, equipment, packaging, etc.

For the sake simplicity, this article will cover validation of analytical methods. Method development and validation are all about setting specifications and making sure that the method can reliably achieve those standards. The specifications are discovered during method development, where an analyst works by trial and error to find the right conditions, that are described by example below. It is a tedious process, but once the proper method for analysis is established (i.e. the right column, the right flow rates, the right wavelength, and right temperatures), you have data that should show a reproducible method. From there, it’s a matter of setting the amount of variance that is tolerable to still accomplish the method (i.e. validation parameters).

Analytical method development is the time when the robustness of a method is established. Robust in this sense, means that you can change parameters of the method without seeing variation in the results – that is, despite conditions being less than optimal, you still get good results. Validation checks the variation in methods – you must get the same results for a given method within a specified percentage or relative standard deviation. If a method has been proven to be robust, it has a much greater chance of passing validation (being within the specified variance).

There are three major types of analytical methods: identity tests, assays, and impurity tests. An identity test proves that a certain molecule is present in a sample. An assay shows how much of a molecule is present in a sample. An impurity test shows how much of the sample has degraded or the relative quantities of impurities present in a sample. There are 6 major parameters tested in the validation of analytical methods: accuracy, precision, specificity, detection limits, quantification limits, and range.

Validation parameters require qualified reference standards. Ideally they will be from a third party, manufactured in an ISO environment that ensures the purity. The qualified reference standards are how meaningful comparisons are made to assess each parameter.

accuracy – how close to the target value the method reliably achieves
precision – how close each measurement is to the other measurements in a series of measurements
specificity – identification of the exact molecule that’s being tested – i.e. the method can discriminate between molecules similar to the target molecule.
detection limit – the smallest quantity of a molecule that can be detected
quantification limit – the smallest quantity of a molecule that can be reliably quantified
range – the smallest and largest amount of a molecule that can be reliably quantified in an analytical test

Details of the method should be clearly listed and explained in the validation report. They are important because they clearly lay out the conditions to execute a given method. Here are a few examples of method conditions:

Description of the method – e.g. HPLC
Type of chromatography column – e.g. C18 Reverse Phase HPLC Column
Flow rate and method durations – e.g. 1mL/min – 20 min runtime
Detection Wavelength – e.g. 210nm
Column Temperature – e.g. 30C

If you have more questions, check out www.oriongmp.com and get a free consultation on putting together your Cannabis related Good Manufacturing Practices and Quality Manufacturing Systems.