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General Treatments / . Health. . .
« Last post by Sergioavami on Today at 10:35:03 AM »
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General Treatments / . Health. . .
« Last post by Sergioavami on Today at 10:34:34 AM »
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General Treatments / . Health. . .
« Last post by Sergioavami on Today at 10:34:06 AM »
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General Treatments / . Health. . .
« Last post by Sergioavami on Today at 10:33:37 AM »
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5
CBD / Infused Products Virtual Conference
« Last post by Administrator on September 20, 2018, 03:17:32 PM »
Infused Products Virtual Conference

This complimentary virtual conference consists of 5 back-to-back webinars, all on the same day. Hear from experts in the infused products and edibles industry discuss the latest in regulatory compliance, quality and safety issues. Speakers will help attendees better understand GMPs, standards, food safety protocols, vetting supplier quality and much more. Sign up for this complimentary virtual event today.


The post Infused Products Virtual Conference appeared first on Cannabis Industry Journal.



The post Infused Products Virtual Conference appeared first on Cannabis Industry Journal.


Source: Infused Products Virtual Conference
6
CBD / How to Vet Suppliers in Cannabis Product Manufacturing
« Last post by Administrator on September 18, 2018, 07:06:11 PM »
How to Vet Suppliers in Cannabis Product Manufacturing

A step-by-step guide to evaluating potential suppliers of packaging, active ingredients and excipients for cannabis-infused products.


The post How to Vet Suppliers in Cannabis Product Manufacturing appeared first on Cannabis Industry Journal.



The quality of your edible cannabis product can only be as reliable as the components that comprise it. The three types of components include active ingredients (such as CBD oil), packaging components  (such as the bottles that hold finished product) and inactive ingredients (such as coconut oil). When evaluating a potential supplier for these three areas, a risk-based method follows a vendor selection process that highlights critical ingredients and also adequately assesses excipients. With this approach, the vetting process for a supplier is based on the impact the potential ingredient or component will have on the quality and purity of the finished product.


Choose only those suppliers who can provide certification that the packaging components are food-grade or food-safeThere are three basic categories to guide vendor assessment. Is the supplier providing 1) a packaging component with product contact, 2) an excipient, or inactive ingredient, or 3) the active ingredient? Regardless of the category, due to the factious nature of cannabis, it is important to first verify with a vendor that it will sell its products to a company in the cannabis industry. Once that is determined, the evaluation process may begin.


Packaging Components


Sourcing validation is a critical initial step in the production process. (image credit: Lucy Beaugard)

Packaging components, such as bottles and caps, are considered primary packaging because they have direct contact with the finished product. Suppliers of the primary packaging must be able to provide assurance that their goods do not contain additives that are harmful to consumers. Therefore, choose only those suppliers who can provide certification that the packaging components are food-grade or food-safe. Reputable vendors will also be able to provide a certificate of compliance, also known as a certificate of conformance, which states that the component meets specifications required for that part. Many cannabis regulations require finished products to be sold in child-resistant packaging, so the supplier will need to provide child-resistant certification for the packaging components, if applicable.


Excipients


Excipients are ingredients that are added to a product for the purposes of streamlining the manufacturing process and enhancing physical characteristics such as taste and color. Some examples could include coconut oil, starch and alcohol. Though they do not have the same critical nature as active ingredients, their potential risk to a finished product is generally greater than that of a packaging component. As such, there are additional factors to consider for an excipient vendor. Verify with the supplier that it can provide the following documentation. While governing regulations may not require some information, the data included in these documents are important to ensure the quality of your finished product.



  • Certificate of Analysis (or, certificate of conformance), for each lot of material. The information on a certificate, including the tests performed, specifications and test results must be sufficient to determine if the material is acceptable for use in the product.

  • Allergen Statement. This statement is important to accurately include or disclaim allergens on the finished product label.

  • Residual Solvent Statement. Solvents are commonly used to bolster the manufacturing process for a material. In order to maintain acceptable levels of residual solvents in a final product, it is necessary to also consider the toxicity and level of each solvent in the raw material.

  • Heavy Metals Certification. Since metals pose a risk to consumer safety, it is important to know what amounts, if any, are being contributed to your product by raw materials.


Because changes in an excipient can impact your finished product, make every attempt to obtain a commitment from a supplier to notify you if changes are made to the excipient’s specifications.


Active Ingredients


Cannabis oil is the ingredient that, when the edible cannabis product is consumed, is biologically “active.” Thus, it is considered to be the active ingredient in cannabis products. Since cannabis oil has a direct impact on the quality of a product, it is critical that the oil supplier be appropriately evaluated. One of the main considerations for a cannabis oil supplier is whether the supplier is willing to host initial and periodic audits of its manufacturing facility. Such audits are crucial in assessing the capability of the vendor to comply with regulatory requirements and established procedures – can the supplier consistently provide quality material? The answer to this question is too important to risk for you and your customers.As anyone working in the industry has experienced, anything related to cannabis is placed under an unprecedented critical lens.


Additionally, verify the oil supplier will provide key documentation, such as that listed above for excipients, to support the quality and purity of the oil. And last but not least, ensure the information reported by the supplier is adequate to meet the requirements of your finished product.


Evaluation guidelines and criteria such as these should be added to standard operating procedures to ensure consistency and quality across all products. As anyone working in the industry has experienced, anything related to cannabis is placed under an unprecedented critical lens. The importance of consumer safety and bolstering industry integrity is paramount. Sourcing validation is a critical initial step in the production process that can directly impact a company’s success and longevity in the cannabis industry.


The post How to Vet Suppliers in Cannabis Product Manufacturing appeared first on Cannabis Industry Journal.


Source: How to Vet Suppliers in Cannabis Product Manufacturing
7
CBD / How to Vet Suppliers in Cannabis Product Manufacturing
« Last post by Administrator on September 14, 2018, 04:39:37 AM »
How to Vet Suppliers in Cannabis Product Manufacturing

A step-by-step guide to evaluating potential suppliers of packaging, active ingredients and excipients for cannabis-infused products.


The post How to Vet Suppliers in Cannabis Product Manufacturing appeared first on Cannabis Industry Journal.



The quality of your edible cannabis product can only be as reliable as the components that comprise it. The three types of components include active ingredients (such as CBD oil), packaging components  (such as the bottles that hold finished product) and inactive ingredients (such as coconut oil). When evaluating a potential supplier for these three areas, a risk-based method follows a vendor selection process that highlights critical ingredients and also adequately assesses excipients. With this approach, the vetting process for a supplier is based on the impact the potential ingredient or component will have on the quality and purity of the finished product.


Choose only those suppliers who can provide certification that the packaging components are food-grade or food-safeThere are three basic categories to guide vendor assessment. Is the supplier providing 1) a packaging component with product contact, 2) an excipient, or inactive ingredient, or 3) the active ingredient? Regardless of the category, due to the factious nature of cannabis, it is important to first verify with a vendor that it will sell its products to a company in the cannabis industry. Once that is determined, the evaluation process may begin.


Packaging Components


Sourcing validation is a critical initial step in the production process. (image credit: Lucy Beaugard)

Packaging components, such as bottles and caps, are considered primary packaging because they have direct contact with the finished product. Suppliers of the primary packaging must be able to provide assurance that their goods do not contain additives that are harmful to consumers. Therefore, choose only those suppliers who can provide certification that the packaging components are food-grade or food-safe. Reputable vendors will also be able to provide a certificate of compliance, also known as a certificate of conformance, which states that the component meets specifications required for that part. Many cannabis regulations require finished products to be sold in child-resistant packaging, so the supplier will need to provide child-resistant certification for the packaging components, if applicable.


Excipients


Excipients are ingredients that are added to a product for the purposes of streamlining the manufacturing process and enhancing physical characteristics such as taste and color. Some examples could include coconut oil, starch and alcohol. Though they do not have the same critical nature as active ingredients, their potential risk to a finished product is generally greater than that of a packaging component. As such, there are additional factors to consider for an excipient vendor. Verify with the supplier that it can provide the following documentation. While governing regulations may not require some information, the data included in these documents are important to ensure the quality of your finished product.



  • Certificate of Analysis (or, certificate of conformance), for each lot of material. The information on a certificate, including the tests performed, specifications and test results must be sufficient to determine if the material is acceptable for use in the product.

  • Allergen Statement. This statement is important to accurately include or disclaim allergens on the finished product label.

  • Residual Solvent Statement. Solvents are commonly used to bolster the manufacturing process for a material. In order to maintain acceptable levels of residual solvents in a final product, it is necessary to also consider the toxicity and level of each solvent in the raw material.

  • Heavy Metals Certification. Since metals pose a risk to consumer safety, it is important to know what amounts, if any, are being contributed to your product by raw materials.


Because changes in an excipient can impact your finished product, make every attempt to obtain a commitment from a supplier to notify you if changes are made to the excipient’s specifications.


Active Ingredients


Cannabis oil is the ingredient that, when the edible cannabis product is consumed, is biologically “active.” Thus, it is considered to be the active ingredient in cannabis products. Since cannabis oil has a direct impact on the quality of a product, it is critical that the oil supplier be appropriately evaluated. One of the main considerations for a cannabis oil supplier is whether the supplier is willing to host initial and periodic audits of its manufacturing facility. Such audits are crucial in assessing the capability of the vendor to comply with regulatory requirements and established procedures – can the supplier consistently provide quality material? The answer to this question is too important to risk for you and your customers.As anyone working in the industry has experienced, anything related to cannabis is placed under an unprecedented critical lens.


Additionally, verify the oil supplier will provide key documentation, such as that listed above for excipients, to support the quality and purity of the oil. And last but not least, ensure the information reported by the supplier is adequate to meet the requirements of your finished product.


Evaluation guidelines and criteria such as these should be added to standard operating procedures to ensure consistency and quality across all products. As anyone working in the industry has experienced, anything related to cannabis is placed under an unprecedented critical lens. The importance of consumer safety and bolstering industry integrity is paramount. Sourcing validation is a critical initial step in the production process that can directly impact a company’s success and longevity in the cannabis industry.


The post How to Vet Suppliers in Cannabis Product Manufacturing appeared first on Cannabis Industry Journal.


Source: How to Vet Suppliers in Cannabis Product Manufacturing
8
CBD / Distillation Of Your Cannabis Extract: Ignorance Is Not Bliss
« Last post by Administrator on September 13, 2018, 06:27:04 PM »
Distillation Of Your Cannabis Extract: Ignorance Is Not Bliss

This article will help businesses better understand the distillation chemistry used to produce a cannabis distillate product.


The post Distillation Of Your Cannabis Extract: Ignorance Is Not Bliss appeared first on Cannabis Industry Journal.



In a previous article I discussed the elephant in the room for clients of laboratory services- the possibility of errors, inaccurate testing and dishonesty.


Now, I will explain how the current “smoke and mirrors” of distillation claims are impacting the cannabis industry in the recreational and medical areas. We have all heard the saying, “ignorance is bliss.” But, the ignorance of how distillation really works is creating misinformation and misleading consumers.


That is, just because a cannabis extract has been distilled, doesn’t mean it is safer.There have been reports of people claiming that “Distilled cannabis productsthat are Category 2 distillate are pesticide free and phosphate free, while Category 1 has pesticides and phosphates, but within acceptable limits”


The problem is that these claims of Category 1 and Category 2 cannot be proven just by saying they are distilled. Ignorance of the physical chemistry rules of distillation will lead to increased concentrations of pesticides and other organic contaminants in the supposedly purified cannabis distillate. That is, just because a cannabis extract has been distilled, doesn’t mean it is safer.


So, let’s look at a basic physical chemistry explanation of the cannabis distillation process.



  • First off, you must have an extract to distill. This extract is produced by butane, carbon dioxide or ethanol extraction of cannabis botanical raw material. This extract is a tarry or waxy solid. It contains cannabinoids, terpenes and other botanical chemicals. It will also contain pesticides, organic chemicals and inorganic chemicals present in the raw material. The extraction process will concentrate all of these chemical compounds in the final extract.

  • Now you are ready to distill the extract. The extract is transferred to the vacuum distillation vessel. Vacuum distillation is typically used so as to prevent the decomposition of the cannabinoid products by thermal reactions or oxidation. Under a vacuum, the cannabinoids turn into a vapor at a lower temperature and oxygen is limited.

  • Part of the vacuum distillation apparatus is the distillation column. The dimensions of this column (length and width) along with the packing or design (theoretical plates) will determine the efficiency of distillation separation of each chemical compound. What this means is that the more theoretical plates in a column, the purer the chemical compound in the distillate. (e.g. Vigreux column = 2-5 theoretical plates, Oldershaw column = 10-15 plates, Sieve plate column = any number you can pay for).

  • The temperature and vacuum controls must be adjustable and accurate for all parts of the distillation apparatus. Failure to control the temperature and vacuum on any part to the apparatus will lead to:

    • Thermal destruction of the distillate

    • Oxidation of the distillate

    • Impure distillate




Now, you can see that a proper distillation apparatus is not something you throw together from a high school chemistry lab. But just having the proper equipment will not produce a pure cannabis product. The physical chemistry that takes place in any distillation is the percentage a chemical compound that occurs in the vapor phase compared to the percentage in liquid phase.So, how can you produce a cannabis distillate that is clean and pure?


For example, let’s look at whiskey distillation. In a simple pot still, alcohol is distilled over with some water to produce a mixture that is 25%-30% ethanol. Transferring this distillate to an additional series of pot stills concentrates this alcohol solution to a higher concentration of 85%-90% ethanol. So, each pot still is like a single theoretical plate in a distillation column.


But, if there are any chemical compounds that are soluble in the vapor produced, they will also be carried over with the vapor during distillation. This means that pesticides or other contaminants that are present in the cannabis extract can be carried over during distillation!


So, how can you produce a cannabis distillate that is clean and pure?



  • Produce a cannabis extract that has lower concentrations of bad chemicals. Since a lot of the cannabis extracts available for distillation are coming from grey-black market cannabis, the chances of contamination are high. So, the first thing to do is to set up an extraction cleanup procedure.

    • An example of this is to wash the raw extract to remove inorganic phosphates. Then recrystallize the washed extract to remove some of the pesticides.



  • Make sure that the distillation apparatus is set up to have proper temperature and vacuum controls. This will limit production of cannabis decomposition products in the final distillate.

  • Make sure your distillation apparatus has more than enough theoretical plates. This will make sure that your cannabis distillate has the purity needed.

  • Finally, make sure that the staff that operates the cannabis distillation processes are well trained and have the experience and knowledge to understand their work.


Inexperienced or under-trained individuals will produce inferior and contaminated product. Additional information of extract cleanup and effective vacuum distillation can be obtained by contacting the author.


The post Distillation Of Your Cannabis Extract: Ignorance Is Not Bliss appeared first on Cannabis Industry Journal.


Source: Distillation Of Your Cannabis Extract: Ignorance Is Not Bliss
9
Quality Plans for Lab Services:  Managing Risks as a Grower, Processor or Dispensary, Part 5

After outlining the risks to address in quality plans earlier in the series, Dr. Askew shows how your brand can suffer in the court of public opinion.


The post Quality Plans for Lab Services:  Managing Risks as a Grower, Processor or Dispensary, Part 5 appeared first on Cannabis Industry Journal.



Protection in the Court of Public Opinion


In the last four articles, I have outlined areas that impact your operations as they apply to laboratory quality programs. But this article will take a different path. It will focus on protecting your crop and brand along with any business that utilizes your crop, such as dispensaries or edible manufactures in the court of public opinion.


Now, the elephant in the room for cannabis companies is the difference between rules written by the state and their enforcement by the state. There are many anecdotal stories out there that can be used as case studies in identifying ways to protect your brand. Remember, consumers and the media caught them, not the regulators.


Cheating in the cannabis industry: growers, dispensaries, edibles manufactures, etc. This includes:



  1. Finding laboratories that will produce results that the client wants (higher potency numbers)

  2. Not testing for a particular contaminant that may be present in the cannabis product.

  3. Selling failed crops on the gray or black market.

  4. Claiming to regulators that the state rules are unclear and cannot be followed (e.g. So, give me another chance, officer)


So why should you be worried? Because, even if the state where you operate fails to enforce its own rules, the final end-user of your product will hold you accountable! If you produce any cannabis product and fail to consider these end-users, you will be found out in the court of public opinion by either the media or by the even more effective word of mouth (e.g. Social Media).


So, let’s take a look at some recent examples of these problems:



  1. “Fungus In Medical Marijuana Eyed As Possible Cause In California Man’s Death”

  2. “Pesticides and Pot: What’s California Smoking?”

  3. Buyers beware: California cannabis sold Jan. 1 could be tainted”


Each of these reports lists contamination by microbial stains or pesticides as being rampant within the California market whose products are used for medical or recreational use. Just imagine the monetary losses these cannabis businesses faced for their recalled cannabis product when they got caught. Remember, consumers and the media caught them, not the regulators.Institute a quality program in your business immediately.


How can you be caught? There are many different ways:



  1. Consumer complaints to the media

  2. Secret shopper campaigns (more to come on that in the next article)

  3. Media investigations

  4. Social media campaigns


What are the effects on your business? Product recalls such as these two to hit the California market recently.


So, what should you do to produce an acceptable product and provide reasonable protection to your cannabis business? Institute a quality program in your business immediately. This quality program will include areas of quality assurance and quality control for at least these areas.



  1. Growing

  2. Processing or formulating

  3. Shipping

  4. Dispensing

  5. Security

  6. Training of staff

  7. Laboratory services


Setting up and supporting these programs requires that your upper management impose both a rigorous training program and make employee compliance mandatory. Otherwise, your business will have an unreasonable risk of failure in the future.


Further information on preparing and instituting these types of quality assurance and quality control programs within your business can be found at the author’s website.


The post Quality Plans for Lab Services:  Managing Risks as a Grower, Processor or Dispensary, Part 5 appeared first on Cannabis Industry Journal.


Source: Quality Plans for Lab Services:  Managing Risks as a Grower, Processor or Dispensary, Part 5
10
CBD / Documentation: Are You Prepared?
« Last post by Administrator on September 12, 2018, 11:29:06 PM »
Documentation: Are You Prepared?

Knowing the types of documents required for standards and regulations will help you stay ahead of compliance issues at your facility.


The post Documentation: Are You Prepared? appeared first on Cannabis Industry Journal.



Documents play a key role in the world of regulations and global standards. Documents tell a story on programs development, implementation and verification during an inspection or audit. Documents are used as evidence to determine conformance to the law or standard. However, do you know what kind of documents may be reviewed during a regulatory inspection or a food safety audit? Are you prepared to show that the implementation of regulatory requirements or a standard is done efficiently at your facility?


Inspectors and auditors will look for compliance either to regulations or to a standard criterion. Regulations and standards require that documentation is controlled, secured and stored in an area where they cannot deteriorate. Therefore, writing a Document Management Program (DMP) will help a business owner ensure consistency in meeting this and other requirements.Radojka Barycki will host a a plenary session titled, “Cannabis: A Compliance Revolution” at the 2018 Food Safety Consortium | Learn More


A well-developed and implemented DMP provides control over documents by providing a number sequence and revision status to the document. In addition, ownership for development, review and distribution of the documents are assigned to specific individuals within the company to ensure that there are no inconsistencies in the program. Documents must also have the name of the company in addition to a space to write the date when the record is generated. It is recommended to include the address if there are multiple operational sites within the same company.


There are different types of documents that serve as support to the operations:



  1. Program: A written document indicating how a business will execute its activities. When it comes to the food industry, this is a written document that indicates how quality, food safety and business activities are controlled.

  2. Procedures: General actions conducted in a certain order. Standard Operational Procedures (SOPs) allow the employee to know what to do in general. For example, a truck receiving procedure only tells the employee what the expected conditions are when receiving a truck (cleanliness, temperature, etc.) However, it doesn’t tell the employee how to look for the expected conditions at the time of the truck arrival.

  3. Work Instructions: Detailed actions conducted in a certain order. For example, truck inspection work instruction tells the employee what steps are to be followed to perform the inspection.

  4. Forms: Documents used to record activities being performed. 

  5. Work Aids: are documents that provide additional information that is important to perform the job and can be used as a quick reference when performing the required activities within the job. 


Are you prepared to face document requirements now and in the future?

The inspectors and auditors base their role on the following saying: “Say what you do. Do what you say. Prove it!” The programs say what the company do. The procedures, work instructions and work aids provide information on implementation (Do what you say) and the forms become records that are evidence (prove) that the company is following their own written processes.


Regulatory requirements for cannabis vary from state to state. In general, an inspector may ask a cannabis business to provide the following documentation during an inspection:



  1. Business License(s)

  2. Product Traceability Programs and Documents

  3. Product Testing (Certificate of Analysis – COAs)

  4. Certification Documents (applicable mainly to cannabis testing labs)

  5. Proof of Destruction (if product needs to be destroyed due to non-compliance)

  6. Training Documents (competency evidence)

  7. Security Programs


As different states legalize cannabis, new regulatory requirements are being developed and modeled after the pharma, agriculture and food industries. In addition, standards will be in place that will provide more consistency to industry practices at a global level. The pharma, agriculture and food industries base their operations and product safety in programs such as cGMPs, GAPs, HACCP-based Food Safety Management Systems and Quality Management Systems. Documents required during an inspection or audit are related to:



  1. Good Agricultural Practices (GAPs)

  2. Current Good Manufacturing Practices (cGMPs)

  3. Food Safety Plan Documents

  4. Ingredient and Processing Aids Receiving

  5. Ingredient and Processing Aids Storage

  6. Operational Programs (Product Processing)

  7. Final Product Storage

  8. Final Product Transportation

  9. Defense Program

  10. Traceability Program

  11. Training Program

  12. Document Management Program


In the always evolving cannabis industry, are you prepared to face document requirements now and in the future?


The post Documentation: Are You Prepared? appeared first on Cannabis Industry Journal.


Source: Documentation: Are You Prepared?
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