Tag Archives: certificate of analysis

How to Vet Suppliers in Cannabis Product Manufacturing

By Amy Davison, Amy Davison
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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.

Documentation: Are You Prepared?

By Radojka Barycki, Radojka Barycki
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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?

Supplier Quality Audits: A Critical Factor in Ensuring GMP Compliance

By Amy Scanlin, Amy Scanlin
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Editor’s Note: This is an article submission from the EAS Consulting Group, LLC team.


To Audit, or not to audit? Not even a question! Audits play a crucial role in verifying and validating business practices, ensuring suppliers are meeting their requirements for Good Manufacturing Practices (GMPs), and most importantly, protecting your interests by ensuring that you consistently receive a compliant and quality product. Audits can help ensure sound business procedures and quality systems, including well-established SOPs, verification and documentation of batch records, appropriate sanitation practices and safe storage and use of ingredients. Audits can also identify deficiencies, putting into motion a corrective action plan to mitigate any further challenges. While a detailed audit scheme is commonplace for established industries such as food, pharmaceuticals and dietary supplements, it is equally important for the cannabis industry to ensure the same quality and safety measures are applied to this budding industry.

If the question then is not whether to audit, perhaps the question is how and when to audit, particularly in the case of a company’s suppliers.This is an opportunity to strengthen the working relationship with each side demonstrating a commitment to the end product.

Supplier audits ensure first and foremost that the company with which you have chosen to work is operating in a manner that meets or exceeds your quality expectations – and you should have expectations because ultimately your product is your responsibility. Any issues that arise, even if they are technically the fault of a supplier, become your issue, meaning any enforcement action taken by your state regulators will directly impact your business. Yes, your supplier may provide you with a batch Certificate of Analysis but you should certify their results as well.

Audits are a snapshot of a moment in time and therefore should be conducted on a regular basis, perhaps biennially or even annually, if they are a critical supplier. In some cases, companies choose to bring in third-party auditors to provide an objective assessment of suppliers. This is especially helpful when the manufacturer or customer does not have the manufacturing, compliance and analytical background to accurately interpret data gathered as part of the audit. With the responsibility for ensuring ingredient identity and product integrity falling on the manufacturer, gaining an unbiased and accurate assessment is imperative to reducing the risk to your business.

Conducting a supplier audit should be well planned in advance to ensure both sides are ready. The audit team must be prepared and able to perform their duties via a combination of education, training and experience. A lead auditor will oversee the team and ultimately will also oversee the results, verifying all nonconformities have been properly identified. They will also work with the supplier to conduct a root cause analysis for those nonconformities and develop a corrective action plan to eliminate them from occurring in the future. The audit lead will also verify follow-up results.

Auditors should discuss with the supplier in advance what areas will be observed, what documentation will need to be ready for review and they should conduct their assessments with professionalism. After all, this is an opportunity to strengthen the working relationship with each side demonstrating a commitment to the end product.This is your chance to ensure your suppliers are performing and will meet your business, quality and product expectations.

Auditors must document that ingredient identity and finished product specifications are verified by test methods appropriate for the intended purpose (such as a whole compound versus a powder). State regulations vary so be certain to understand the number and types of required tests. Once the audit is complete and results are analyzed, you, the manufacturer, have an opportunity to determine if the results are acceptable. Remember, it is your product, so ultimately it is your responsibility to review the available data and release the product to market, you cannot put that responsibility on your supplier.

Quality Agreements as Part of a Business Agreement

There are opportunities to strengthen a partnership at every turn, and one way to set a relationship on the right path is to include a quality agreement as part of a business agreement. A quality agreement lays out your expectations for your suppliers, what you are responsible for and is a living document that, once signed, demonstrates their commitment to upholding the standards you expect. Just as with a business agreement, have any quality agreements reviewed by an outside expert to ensure the wording is sound and that your interests are protected. This is just another step in the development of a well-executed business plan and one that solidifies expectations and provides consequences when those expectations are not met.

Supplier audits must be taken seriously as they are opportunities to protect your brand, your business and your consumers. Enter into an audit as you would with any business endeavor – prepared. This is your chance to ensure your suppliers are performing and will meet your business, quality and product expectations.

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EVIO Labs: The First Accredited Cannabis Lab in Florida

By Lauren Masko, Lauren Masko
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EVIO Logo

EVIO Labs recently became the first cannabis laboratory in Florida to obtain ISO 17025 accreditation. Perry Johnson Laboratory Accreditation, Inc. (PJLA), an organization that provides third-party assessments to ISO/IEC 17025, accredited EVIO Labs. The assessment process that lead to ISO 17025 accreditation for EVIO Labs included a thorough review of their quality management system, their capability to perform potency and contaminant testing for cannabis products.

Tracy Szerszen, president and operations manager at PJLA, encourages this international standard for laboratories to provide confidence to end-users that the test results they receive are reliable. She says laboratories that achieve this accreditation are showing they have the proper tools, equipment and staff to provide accurate testing. “It is a very critical component of the industry, and becoming accredited provides the assurance that laboratories are performing to the highest standard,” says Szerszen. “EVIO Labs has taken the right step in their commitment towards meeting this standard and providing clean and safe cannabis for the patients of Florida.”

PJLAEVIO Labs provides cannabis testing for cannabinoid and terpene profiles, microbiological and pesticides contamination, residual solvent, heavy metals, mycotoxins, water activity and moisture content. Chris Martinez, co-founder and president of EVIO Labs Florida explains that the Florida Department of Health mandates that an independent third-party laboratory tests medical cannabis to ensure that these products are safe for human consumption. Martinez says their first priority is the safety of their patients, and ensuring that EVIO Labs provides clean and safe cannabis for Florida.

Chris Martinez
Chris Martinez, co-founder and president of EVIO Labs Florida

Martinez launched their laboratory with some help from Shimadzu last year. “Our Broward lab is powered by Shimadzu with over $1.2M in the latest testing equipment utilizing LCMS technology with the world’s fastest polarity switching time of 5 m/sec and scan speeds of 30,000 u/sec with UF Qarray sensitivity 90 times that of previously available technologies,” says Martinez. According to Martinez, their licensing agreement with EVIO Labs (OTC:SGBYD) marked a first for the publicly traded company with exclusivity in the Florida market. The agreement includes proprietary testing methodologies, operating procedures, training and support.

Every certificate of analysis is reviewed by a lab director with over 20 years of experience operating in FDA regulated labs. Martinez says that EVIO has some of the most advanced technology in the industry, which provides them the opportunity to quickly provide results, frequently as fast as a 24-hour period. Martinez and his team are currently building a 3,300 square-foot laboratory in Gainesville, which is expected to be running by March of this year.

The Practical Chemist

Building the Foundation of Medical Cannabis Testing – Understanding the Use of Standards and Reference Materials – Part 2

By Joe Konschnik
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In the last article I referred to the analogy of the analytical reference material being a keystone of the laboratory foundation, the stone upon which all data relies. I then described the types of reference materials and their use in analytical testing in general terms. This article will describe the steps required to properly manufacture and deliver a certified reference material (CRM) along with the necessary documentation.

A CRM is an exclusive reference material that meets strict criteria defined by ISO Guide 34 and ISO/IEC 17025.  ISO is the International Organization for Standardization and IEC is the International Electrotechnical Commission. These organizations work together to set globally recognized standards. In order for a reference material to be labeled as a CRM it must 1) be made with raw or starting materials which are characterized using qualified methods and instruments, 2) be produced in an ISO-accredited lab under documented procedures, and 3) fall under the manufacturer’s scopes of accreditation. Verifying a CRM supplier has these credentials is easily done by viewing their certificates which should include their scopes of accreditation. Restek_accredit

There are many steps required to produce a CRM that meets the above three criteria.  The first step requires a review of the customer’s, or end-user’s requirements to carefully define what is to be tested, at what levels and which analytical workflow will be used.  Such information enables the producer to identify the proper compounds and solvents required to properly formulate the requested CRM.

The next step requires sourcing and acquiring the raw, or starting materials, then verifying their compatibility and stability using stability and shipping studies in accordance with ISO requirements. Next the chemical identify and purity of the raw materials must be characterized using one or more analytical techniques such as: GC-FID, HPLC, GC-ECD, GC-MS, LC-MS, refractive index and melting point. In some cases, the percent purity is changed by the producer when their testing verifies it’s different from the supplier label. All steps are of course documented.

restek_CRMThe producer’s analytical balances must be verified using NIST traceable weights and calibrated annually by an accredited third party provider to guarantee accurate measurement. CRMs must be prepared using Class A volumetric glassware, and all ampules and vials used in preparation and final packaging must be chemically treated to prevent compound degradation during storage. Next, CRMs are packaged in an appropriate container, labeled then properly stored to maintain the quality and stability until it’s ready to be shipped. All labels must include critical storage, safety and shelf life information to meet federal requirements. The label information must be properly linked to documentation commonly referred to as a certificate of analysis (COA) which describes all of the above steps and verifies the traceability and uncertainty of all measurements for each compound contained in the CRM. Restek_CRM2

My company, RESTEK, offers a variety of documentation choices to accompany each CRM. Depending on the intended use and data quality objectives specified by the end-user, which were defined way back at the first step, three options are typically offered: They include gravimetric only, qualitative which includes gravimetric, and fully quantitative which includes all three levels of documentation. The graphic to the right summarizes the three options and what they include.

It’s important to understand which level you’re purchasing especially when ordering a custom CRM from a supplier. Most stock CRMs include all three levels of documentation, but it’s important to be sure.

Understanding what must be done to produce and deliver a CRM sets it apart from other reference material types, however it’s important to understand there are some instances where CRMs are either not available, nor required and in those situations other types of reference materials are perfectly acceptable.

If you have any questions or would like more details about reference materials please contact me, Joe Konschnik at (800) 356-1688 ext. 2002 by phone, or email me at joe.konschnik@restek.com.