Tag Archives: accreditation

Navigating ISO/IEC 17025: Key Considerations for Cannabis Lab Software

By Montserrat Valdes
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In some states, cannabis testing facilities must undergo a third-party audit as a condition for obtaining their license. This may involve obtaining an ISO/IEC 17025 accreditation, which requires an evaluation from a qualified auditor. Alternatively, some laboratories may undergo a voluntary audit in certain regions to showcase their competency.

ISO/IEC 17025 is a widely acknowledged global benchmark for the expertise of testing and calibration laboratories. It establishes guidelines for laboratories to showcase their technical proficiency and ability to produce precise and trustworthy results.

For cannabis testing laboratories, obtaining ISO/IEC 17025 accreditation can offer a significant edge over their rivals. Such accreditation can result in several advantages, such as improved credibility, lower operational expenses, better conformity with local and state regulations and more efficient cross-border trade.

Integrating any standard into a regulated enterprise can be a complex undertaking and ISO/IEC 17025 is no exception. This standard puts a strong emphasis on quality by requiring laboratories to exhibit their impartiality, consistency and proficiency in all aspects of their work. Compliance with ISO/IEC 17025 necessitates timely and secure data retrieval, which is difficult to achieve without an information management system. Therefore, laboratories are increasingly turning to laboratory information management systems (LIMS) to modernize their practices, improve quality and meet ISO/IEC 17025 compliance standards. This article explores the critical factors that laboratory managers and staff should consider when selecting a LIMS that can help them fulfill the demands of ISO/IEC 17025. However, let’s first discuss the sections the ISO/IEC 17025 requirements are classified into.

ISO/IEC 17025 Requirements 

The ISO/IEC 17025 requirements are divided into five sections:

  1. General Requirements (Section 4): The fourth section of the ISO/IEC 17025:2017 standard details the general conditions that laboratories must follow. This section is primarily concerned with two critical aspects: impartiality and confidentiality. The impartiality requirement mandates laboratories to remain unbiased and take measures to prevent any potential bias. Similarly, the confidentiality requirement mandates that any information collected or generated during laboratory operations must be treated as private and safeguarded adequately to prevent unauthorized access. In instances where the release of confidential information is necessary by law or contract, the laboratory must communicate such release in an appropriate and timely manner.
  2. Structural Requirements (Section 5): In order to achieve the three key objectives of competence, impartiality, and consistent operations, this section addresses the fundamental organizational requirements of a laboratory. This entails being a legal entity with well-defined management responsibilities and documenting all activities, procedures and methods that fall within the standard’s scope. It highlights the importance of human resources by requiring laboratories to provide individuals with the necessary authority and resources to identify and rectify deviations from procedures, methods and the quality management system.
  3. Resource Requirements (Section 6): This section highlights the crucial role of resources in helping a laboratory achieve its objectives and maintain high standards. The section covers five areas, namely personnel, facility and working environment, equipment, metrological traceability and third-party products and services. To meet the standard’s requirements, personnel must demonstrate competence and impartiality, and lab personnel must record their current training status. Lab staff should also be provided with adequate resources to perform their duties. The facility and working environment should be suitable for generating accurate analytical results, while equipment must be properly calibrated and maintained. Metrological traceability is important to establish the connection between measurement results and a reference. Additionally, it is essential to thoroughly evaluate and approve third-party products and services to ensure their suitability. Clear communication of the requirements to third parties is also necessary in this regard.
  4. Process Requirements (Section 7): This section of the standard outlines 11 essential processes that aim to improve efficiency in laboratory operations. The processes include evaluating requests, tenders, and contracts, as well as selecting, verifying and validating methods. This section covers areas such as sampling, test item handling, and technical record-keeping. Other requirements include reporting outcomes, managing complaints and non-conforming work and controlling data and information management, which is especially important in the current digital era.
  5. Management System Requirements (Section 8): Section 8 deals with the laboratory’s management system, which must support consistent adherence to the standard’s requirements while ensuring the quality of the laboratory results. The section offers two options for the management system: Option A for new systems and Option B for existing systems driven by ISO 9001. The section consists of eight tasks which involve activities such as documenting the quality management system (QMS), identifying and addressing potential risks and opportunities, implementing measures for improvements and taking corrective actions. The final clause of the section involves conducting an internal audit of the laboratory’s management system to ensure it complies with the standard’s requirements.

Key Considerations for Selecting a Cannabis Lab Testing Software or LIMS

A cloud-based cannabis lab testing software to manage staff training with ease

Before selecting a Laboratory Information Management System (LIMS) for your cannabis testing lab, it is crucial to comprehend the informatics requirements of your laboratory. This involves understanding analysis necessities, limitations on reporting and data sharing, demands for instrument interfacing, requirements for sample barcoding and tracking, and procedures for ensuring quality assurance. Once all this is in place, a laboratory should take into account the following considerations:

Technology Considerations

When considering technology options, it’s important to consider future growth, data management and security and regulatory responsibilities. If a laboratory expects to grow in the future, it should consider investing in technologies that could enhance data management practices and security. The laboratory must also take into account how compliance with ISO/IEC 17025 will impact its future expansion and technological needs. To determine hardware and software investment, the laboratory must consider the type of work it will be performing and the associated regulatory and customer-centric responsibilities. It is also essential to identify the person or team responsible for addressing any potential technological problems, like setting up and maintaining software. If the laboratory wants to avoid procuring IT infrastructure and hiring IT personnel for maintaining LIMS, they should deploy a cloud-based LIMS that eliminates the need to have an elaborate IT infrastructure or dedicated IT staff. 

Cybersecurity Considerations

As the need for cybersecurity continues to grow in various industries, it has become apparent that cannabis testing laboratories are also vulnerable to cybersecurity threats regardless of size. Therefore, it is important to consider additional cybersecurity measures for these laboratories. Although the ISO/IEC 17025 standard does not explicitly mention cybersecurity, it does address the proper control of data in section 7.11. The standard emphasizes that LIMS, whether hosted locally or in the cloud, should be protected from unauthorized access and tampering. To comply with the ISO/IEC 17025 standard, laboratories should integrate cybersecurity considerations into their LIMS selection process. This can be achieved by creating a cybersecurity plan and including cybersecurity controls in the user requirements specification (URS) for LIMS software. Using a pre-built URS that includes cybersecurity controls can simplify the process of evaluating and selecting informatics software for laboratories. It is important to maintain the LIMS to ensure data and information integrity, recording any security breaches or non-conformance and addressing them promptly.

Regulatory Compliance Considerations

Meeting well-designed standards like ISO/IEC 17025 can enhance a laboratory’s operational culture and assure the reproducibility and accuracy of test results. If a laboratory is considering purchasing a LIMS solution and is unsure about how it can align with ISO/IEC 17025 and other regulations and standards, they can refer to resources like ASTM E1578-18 Standard Guide for Laboratory Informatics for guidance. The laboratory’s own requirements list can then be used as a checklist for vendors.

System Agility

A schematic representation of the various requirements of ISO 17025

Laboratories should consider if the LIMS under consideration can handle adding other types of testing, protocols, and workflows in the future. A flexible LIMS that allows for configuring various aspects of the system, such as sample registration screens, test protocols, labels, reports, and measurement units, is essential. When evaluating a vendor’s system, it’s important to understand what makes it user-configurable and how easy it is to make changes. Moreover, you must check if you can make changes in the system without requiring programming skills.

Cost Concerns

For a laboratory to have a clear understanding of what is included in the sales agreement, it is important to provide an estimate or statement of work (SOW) that outlines the details of the anticipated elements with as much specificity as possible. These elements should include the cost of licensing or subscription, core items needed to comply with regulations, the total cost of optional items, and the required services such as LIMS implementation, maintenance, technical support, training, product upgrades, and add-ons. There are two main pricing models for LIMS solutions: a one-time license fee and a subscription fee for cloud-hosted LIMS. If a laboratory has an internal IT team, it may prefer the one-time fee, but a SaaS subscription may be more cost-effective if they don’t have an IT team and want to save on hefty upfront cost. To accurately reflect the various pricing nuances, the estimate or SOW should specify whether the costs are for monthly or annual subscription services, hourly support and training, or a one-time fixed cost. 

The ISO/IEC 17025 accreditation offers several benefits, including improved credibility, lower operational costs, and better conformity with local and state regulations. However, integrating ISO/IEC 17025 requirements into a laboratory’s practices can be challenging. That’s where a cannabis lab testing software comes in. Laboratory managers and staff must consider several critical factors when selecting a LIMS to meet the requirements of ISO/IEC 17025. Key considerations for selecting a LIMS to meet ISO/IEC 17025 requirements with ease include technology considerations, cybersecurity considerations, regulatory compliance considerations, system agility and cost considerations. By meeting the compliance requirements of the ISO/IEC 17025 standard, cannabis testing laboratories can ensure the quality of their results and provide trustworthy services to their customers.

Ask the Experts: Ensuring the Validity of Cannabis Lab Testing

By Cannabis Industry Journal Staff
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Cannabis testing laboratories are one of the major players in the industry for protecting public health. Ensuring that laboratory test results are reliable and valid requires a multipronged approach involving method validation, proficiency testing and performing frequent reviews of equipment and processes.

Cannabis testing laboratories often use a variety of different methods to conduct proficiency testing. Laboratories can either participate in programs run by ISO/IEC 17043-accedited proficiency testing providers or through intralaboratory comparison. Comparing different instruments, methods, technologies against pre-defined criteria is a must when validating methods for a specific type of test and ensuring the competence of the laboratory.

Beyond proficiency testing, there are a number of other stopgaps at a laboratory’s disposal for ensuring valid results, like using accredited certified reference materials, performing checks on measuring equipment frequently, reviewing reported results and retesting retained items. All of that and more is outlined in the ISO/IEC 17025:2017 standard, section 7.7.

labsphoto
What good is a test result if you cannot attest to its validity?

There’s a lot that goes into making sure laboratories provide valid results, much of which is detailed in the accreditation process. For more information, we sit down with Keith Klemm, senior accreditation manager for ANSI National Accreditation Board to learn about laboratory accreditation, method validation and other certifications and credentialing available in the cannabis industry.

Q: Why is method validation important for cannabis test methods? 

Keith Klemm: Because cannabis production, testing, and sales is regulated by each individual state, there are very few standard methods for testing cannabis and cannabis-derived products. Non-standard methods or methods developed by the laboratory must be validated to ensure the methods are fit for their intended purpose. What good is a test result if you cannot attest to its validity? There would be no confidence that the results are accurate. Additionally, while organizations such as ISO, AOAC and ASTM are developing standard methods for use in the laboratory, the wide range of products and matrices being tested require modifications to standard methods. Standard methods used outside their intended scope must also be validated, again to ensure the method remains fit for the intended purpose.

Q: We’re pretty familiar with laboratory accreditation. What other accreditations are available in the cannabis industry?

Klemm: Accreditation programs are available for product certification and personnel credentialing, in addition to laboratory accreditation. ANAB’s product certification program was launched in 2020 and is based on the requirements of ISO/IEC 17065. The program combines the requirements of this standard with specific scheme requirements to attest to the competency of certification bodies who then certify products within the scheme. Two schemes are in development specific to the cannabis industry: Cannabis Safety and Quality (CSQ) and PurityIQ. For personnel credentialing, a new Cannabis Certificate Accreditation Program (C-CAP) was developed and is based on ASTM D8403, Standard Practice for Certificate Programs within the Cannabis and Hemp Industries. It also includes any additional state Responsible Vendor Training requirements.

Q: What are the steps to becoming an accredited cannabis testing laboratory, product certification body, or C-CAP organization?

Klemm: The process begins with a request for quote. The organization prepares for the initial assessment by implementing the requirements of the applicable standards, regulatory requirements, and scheme requirements. ANAB believes in a partnership approach to accreditation with a focus on customer needs while ensuring accreditation requirements are met. Once the organization is ready, an initial document review is performed. The accreditation assessment is then performed on-site by technically skilled and knowledgeable assessors. If any nonconformities are encountered, the organization provides a response with cause and corrective actions. Once all nonconformities are resolved and technical review is completed, a scope of accreditation and certificate are provided to the organization. The technical review may vary depending on the accreditation that is being sought, but the general process of accreditation is the same. After accreditation is achieved, the organization moves into a cycle of surveillance and reassessment as defined by the accreditation program and any scheme requirements.

About Keith Klemm

Keith Klemm is a graduate of Manchester University with a B.S. in Biology.  Keith is an experience laboratory director and operations manager with 30 years’ experience in the laboratory environment and has worked as a senior accreditation manager for ANSI National Accreditation Board for the past five years.

Keith’s areas of expertise include:

  • Microbiological assays for food, medical device, and environmental test matrixes.
  • Environmental chemistry of water and wastewater.
  • Biocompatibility testing of medical devices.
  • ISO/IEC 17025:2017
  • AOAC International – guidelines for food laboratories program requirements
  • 21 CFR Part 58, GLP program requirements
  • EPA NLLAP program requirements
  • AAFCO program requirements
  • FDA ASCA Pilot program for Biocompatibility
  • Michigan Cannabis Regulatory Agency program requirements
  • ISO 20387 Biobanking

AOAC Accreditation: Why Third-Party Approval Matters More Than Ever

By Anthony Repay
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When people have to make important decisions, we often consult a third party to increase our knowledge and confidence in a product. For instance, when choosing a car, an individual may weigh heavily on safety ratings and other awards from organizations such as Consumer Reports. These awards are often boasted and a heavy focus in car commercials because it tells the consumer that a third party has deemed their car valuable to own. For more than 100 years, the Association of Official Agricultural Chemists (AOAC® International) has operated in this exact manner, and has set the bar and guidelines for testing in the cannabis industry through its special program called the Cannabis Analytical Science Program, also known as CASP.

The CASP program is designed to develop standards and validation guidance to evaluate testing methods, as well as the methods’ ability to detect the target organism or compound on the cannabis matrix. With the addition of new states permitting the legal sale of both medical and adult use cannabis and no federal governing body overseeing testing regulations, the value of AOAC cannot be understated, as these guidelines allow cannabis testing laboratories to have their own third-party reference to look to when choosing a compliant testing method to implement in their laboratory.

AOAC was founded in 1884 by the US government as the standard setting body in the country and, in 1991, became an independent association known as AOAC International, with a goal of building a reputation as an international, consensus-based standard-setting body and a conformity assessment organization in analytical sciences. As an independent third-party resource, AOAC has the Performance Tested Methods’ (PTM) and Official Methods of AnalysisSM (OMA) programs for certification of analytical testing methods in both biology and chemistry.

If analytical methods, including proprietary test kits, are deemed acceptable, AOAC provides approved certification, their seal of approval that the method works as designed. Though multiple factors are considered to determine if AOAC approval is given; accuracy and precision of the method are among the most important. For example, when validating a cannabis method for microbiology, AOAC will contract an independent testing facility to conduct a series of tests with known spiked samples to measure the recovery limit of the target microorganism. This allows the organization to determine if the method is sensitive enough to be named an AOAC-approved method through either the PTM or OMA conformity programs. Another way of ensuring the validity of results is by conducting an inclusivity and exclusivity study on a method. In this type of experiment, target organisms are tested while also spiking with non-target organisms to see if there will be a high rate of false positives.

In cannabis, discussions have grown surrounding testing of four strains of Aspergillus, which are A. terreus, A. flavus, A. fumigatus and A. niger. By spiking cannabis with one of the four Aspergillus strains and on a separate sample with a non-target Aspergillus strain such as A. clavatus, it ensures that only the target strains are being recognized and recorded on the method being tested.

This methodology limits the likelihood of unconfirmed positives occurring, ensuring the validity of the results. Of course, when a method is undergoing an actual AOAC evaluation for approval, the testing requirements for both the sensitivity and inclusivity/exclusivity experiments are much more thorough than the explanation above.

Regardless of which AOAC-approved method you select, you can feel confident that most of the “heavy-lifting” is done and that the method is accurate and precise enough to implement in a cannabis testing facility. In turn, the cannabis testing laboratory then only needs to complete their own internal method verification to ensure the method works with their processes, people, environment and product, but on a much smaller scale and aligns with state regulations.

labsphotoOn a consumer safety level, AOAC-approved methods are designed to keep cannabis consumers safe. Whether they are an adult using cannabis or medicinal cannabis patient, the product that is being sold should be held to the highest safety standards. By having a laboratory that is utilizing an independently approved AOAC method, an additional layer of confidence is achieved that the product being consumed is safe. This ultimately limits the number of costly recalls from dispensaries and minimizes risk to consumers. At the end of the day, cannabis testing laboratories want to keep the public safe and it is our job to do so. This means implementing these independently approved methods from agencies such as AOAC at various touch points in the seed to sale cycle to ensure the data is validated and reliable.

Overall, just as it is equally important to get a non-biased and reputable third-party approach to your automobile search, a scientist that is responsible for choosing methods in their cannabis compliance laboratory should also consider these third-party approvals. As a scientist, the goal every day is to report accurate data to help the client and the consumer equally. The cannabis compliance laboratories are the last line of defense in preventing harmful or contaminated products from getting into the marketplace and any extra assurance we have with our testing methodology is always encouraged. Ultimately, AOAC’s work is important and their standard of quality and safety is a must-have in the cannabis laboratory.

SC Labs Develops Comprehensive Hemp Testing Panel

By Cannabis Industry Journal Staff
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SC Labs, a cannabis testing company with roots in Santa Cruz, California, announced this week that they have developed a comprehensive hemp testing panel that covers a number of contaminants on a national regulatory level. In the press release, the company says they aim to fill the void of national hemp testing requirements.

The hemp testing panel they have developed purportedly meets testing standards in states that require contaminant levels below a certain action limit. The SC Labs hemp testing panel could theoretically be used for regulatory compliance testing across the country, reaching action limits and analyte levels that meet the strictest state requirements.

The panel tests for pesticides, heavy metals, microbiology, mycotoxins, residual solvents and water activity.

The panel is one sign of progress on the long road to nationally harmonized testing standards. “As an industry, we’ve been advocating for national, standardized, and transparent testing regulations for years now,” says Jeff Gray, CEO of SC Labs. “The government has been slow to respond so we decided it was time to act. As an industry, we’ve been advocating for national, standardized, and transparent testing regulations for years now. The government has been slow to respond so we decided it was time to act.”

SC Labs is headquartered in Santa Cruz, but has licenses in California, Oregon, Texas and Colorado (pending). Their California and Oregon locations are both ISO 17025-accredited and conducting THC-containing cannabis testing, as well as hemp testing.

Kelab Analitica Becomes First Accredited Cannabis Lab in Colombia

By Cannabis Industry Journal Staff
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Established in 2019, Kelab Analitica is the first laboratory in Colombia to specialize in cannabis and pharmaceutical testing. In March of 2020, the lab began operating and serving the cannabis market in the South American country.

Then in December of 2020, Kelab Analitica obtained ISO/IEC 17025:2017 through Perry Johnson Laboratory Accreditation, making it the very first cannabis testing lab in Colombia to attain accreditation. The lab was also certified shortly after in Good Laboratory Practices by Colombian health authorities for analysis of pharmaceutical products.

The lab has found that ISO 17025 accreditation has helped with their marketing strategy. “As the industry grows, more producers are beginning to understand the importance of working with an accredited laboratory for quality and consistency of results and to comply with international requirements,” says a team member at Kelab Analitica.

In the future, they plan to expand their reach locally in Colombia and look for opportunities to expand in Latin America. They are also engaged in research in chromatography and instrumentation to develop new cannabis testing methods.

ISO/IEC 17025 Accreditation Falls Short for Cannabis Testing Laboratories

By Kathleen May
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What is the role of the Quality Control (QC) Laboratory?

The Quality Control (QC) laboratory serves as one of the most critical functions in consumer product manufacturing. The QC laboratory has the final say on product release based on adherence to established product specifications. Specifications establish a set of criteria to which a product should conform to be considered acceptable for its intended use. Specifications are proposed, justified and approved as part of an overall strategy to ensure the quality, safety, and consistency of consumer products. Subsequently, the quality of consumer products is determined by design, development, Good Manufacturing Practice (GMP) controls, product and process validations, and the specifications applied throughout product development and manufacturing. These specifications are specifically the validated test methods and procedures and the established acceptance criteria for product release and throughout shelf life/stability studies.

The Code of Federal Regulations, 21 CFR Part 211, Good Manufacturing Practice for Finished Pharmaceuticals, provides the minimum requirements for the manufacture of safe products that are consumed by humans or animals. More specifically, 21 CFR Part 211: Subpart I-Laboratory Controls, outlines the requirements and expectations for the quality control laboratory and drug product testing. Additionally, 21 CFR Part 117, Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Food: Subpart B-Processes and Controls states that appropriate QC operations must be implemented to ensure food products are safe for consumption and food packing materials and components are safe and fit for purpose. Both food and drug products must be tested against established specifications to verify quality and safety, and laboratory operations must have the appropriate processes and procedures to support and defend testing results.

ISO/IEC 17025, General Requirements for the Competence of Testing and Calibration Laboratories is used to develop and implement laboratory management systems. Originally known as ISO/IEC Guide 25, first released in 1978, ISO/IEC 17025 was created with the belief that “third party certification systems [for laboratories] should, to the extent possible, be based on internationally agreed standards and procedures”7. National accreditation bodies are responsible for accrediting laboratories to ISO/IEC 17025. Accreditation bodies are responsible for assessing the quality system and technical aspects of a laboratory’s Quality Management System (QMS) to determine compliance to the requirements of ISO/IEC 17025. ISO/IEC 17025 accreditation is pursued by many laboratories as a way to set them apart from competitors. In some cannabis markets accreditation to the standard is mandatory.

The approach to ISO/IEC 17025 accreditation is typically summarizing the standard requirements through the use of a checklist. Documentation is requested and reviewed to determine if what is provided satisfies the item listed on the checklist, which correlate directly to the requirements of the standard. ISO/IEC 17025 covers the requirements for both testing and calibration laboratories. Due to the wide range of testing laboratories, the standard cannot and should not be overly specific on how a laboratory would meet defined requirements. The objective of any laboratory seeking accreditation is to demonstrate they have an established QMS. Equally as critical, for product testing laboratories in particular, is the objective to establish GxP, “good practices”, to ensure test methods and laboratory operations verify product safety and quality. ISO/IEC 17025 provides the baseline, but compliance to Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP) and even Good Safety Practices (GSP) are essential for cannabis testing laboratories to be successful and demonstrate testing data is reliable and accurate.

Where ISO/IEC 17025 accreditation falls short

Adherence to ISO/IEC 17025, and subsequently receiving accreditation, is an excellent way to ensure laboratories have put forth the effort to establish a QMS. However, for product testing laboratories specifically there are a number of “gaps” within the standard and the accreditation process. Below are my “Top Five” that I believe have the greatest impact on a cannabis testing laboratory’s ability to maintain compliance and consistency, verify data integrity and robust testing methods, and ensure the safety of laboratory personnel.

Standard Operating Procedures (SOPs)

The understanding of what qualifies as a Standard Operating Procedure (SOP) is often misunderstood by cannabis operators. An SOP is a stand-alone set of step-by-step instructions which allow workers to consistently carry out routine operations, and documented training on SOPs confirms an employee’s comprehension of their job tasks. Although not required per the current version of the standard, many laboratories develop a Quality Manual (QM). A QM defines an organization’s Quality Policy, Quality Objectives, QMS, and the procedures which support the QMS. It is not an uncommon practice for cannabis laboratories to use the QM as the repository for their “procedures”. The intent of a QM is to be a high-level operations policy document. The QM is NOT a step-by-step procedure, or at least it shouldn’t be.

Test Method Transfer (TMT)

Some cannabis laboratories develop their own test methods, but a common practice in many cannabis laboratories is to purchase equipment from vendors that provide “validated” test methods. Laboratories purchase equipment, install equipment with pre-loaded methods and jump in to testing products. There is no formal verification (what is known as a Test Method Transfer (TMT)) by the laboratory to demonstrate the method validated by the vendor on the vendor’s equipment, with the vendor’s technicians, using the vendor’s standards and reagents, performs the same and generates “valid” results when the method is run on their own equipment, with their own technician(s), and using their own standards and reagents. When discrepancies or variances in results are identified (most likely the result of an inadequate TMT), changes to test methods may be made with no justification or data to support the change, and the subsequent method becomes the “validated” method used for final release testing. The standard requires the laboratory to utilize “validated” methods. Most laboratories can easily provide documentation to meet that requirement. However, there is no verification that the process of either validating in house methods or transferring methods from a vendor were developed using any standard guidance on test method validation to confirm the methods are accurate, precise, robust and repeatable. Subsequently, there is no requirement to define, document, and justify changes to test methods. These requirements are mentioned in ISO/IEC 17025, Step 7.2.2, Validation of Methods, but they are written as “Notes” and not as actual necessities for accreditation acceptance.

Change Control

The standard speaks to identifying “changes” in documents and authorizing changes made to software but the standard, and subsequently the accreditation criteria, is loose on the requirement of a Change Control process and procedure as part of the QMS. The laboratory is not offered any clear instruction of how to manage change control, including specific requirements for making changes to procedures and/or test methods, documented justification of those changes, and the identification of individuals authorized to approve those changes.

Out of Specification (OOS) results

The documentation and management of Out of Specification (OOS) testing results is perhaps one of the most critical liabilities witnessed for cannabis testing laboratories. The standard requires a procedure for “Nonconforming Work”. There is no mention of requiring a root cause investigation, no requirement to document actions, and most importantly there is no requirement to document a retesting plan, including justification for retesting. “Testing into compliance”, as this practice is commonly referred to, was ruled unacceptable by the FDA in the highly publicized 1993 court case United States vs. Barr Laboratories.

Laboratory Safety

FDAlogoSafe laboratory practices are not addressed at all in ISO/IEC 17025. A “Culture of Safety” (as defined by the Occupational Safety and Health Administration (OSHA)) is lacking in most cannabis laboratories. Policies and procedures should be established to define required Personal Protective Equipment (PPE), the safe handling of hazardous materials and spills, and a posted evacuation plan in the event of an emergency. Gas chromatography (GC) is a common test method utilized in an analytical testing laboratory. GC instrumentation requires the use of compressed gas which is commonly supplied in gas cylinders. Proper handling, operation and storage of gas cylinders must be defined. A Preventative Maintenance (PM) schedule should be established for eye wash stations, safety showers and fire extinguishers. Finally, Safety Data Sheets (SDSs) should be printed and maintained as reference for laboratory personnel.

ISO/IEC 17025 accreditation provides an added level of trust, respect and confidence in the eyes of regulators and consumers. However, the current process of accreditation misses the mark on the establishment of GxP, “good practices” into laboratory operations. Based on my experience, there has been some leniency given to cannabis testing laboratories seeking accreditation as they are “new” to standards implementation. In my opinion, this is doing cannabis testing laboratories a disservice and setting them up for failure on future accreditations and potential regulatory inspections. It is essential to provide cannabis testing laboratory owners and operators the proper guidance from the beginning and hold them up to the same rigor and scrutiny as other consumer product testing laboratories. Setting the precedence up front drives uniformity, compliance and standardization into an industry that desperately needs it.

References:

  1. 21 Code of Federal Regulations (CFR) Part 211- Good Manufacturing Practice for Finished Pharmaceuticals.
  2. 21 Code of Federal Regulations (CFR) Part 117;Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Food: Subpart B-Processes and Controls.
  3. ICH Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients; Laboratory Controls.
  4. World Health Organization (WHO).
  5. International Building Code (IBC).
  6. International Fire Code (IFC).
  7. National Fire Protection Association (NFPA).
  8. Occupational Safety and Health Administration; Laboratories.
  9. ASTM D8244-21; Standard Guide for Analytical Operations Supporting the Cannabis/Hemp Industry.
  10. org; ISO/IEC 17025.

Americans for Safe Access Accredited to ISO 17065

By Cannabis Industry Journal Staff
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Late last week, the American Association for Laboratory Accreditation (A2LA) granted ISO/IEC 17065 accreditation to Americans for Safe Access (ASA). This is the first accreditation ever issued to a product certification body in the cannabis market.

ASA is a member-based organization founded in 2002 that seeks to ensure safe and legal access to cannabis for medical purposes and research. Back in 2016, A2LA and ASA partnered on a collaboration to develop the Patient Focused Certification (PFC) program.

What started as a supplement to ISO 17025 for cannabis testing labs to demonstrate a dedication to patient safety, has grown into a more comprehensive certification and consulting program that offers training, business services, company certifications. With the ISO 17065 accreditation, ASA can now deliver PFC certifications that confidently identify reliable and high-quality medical cannabis products, business and services.

Jonathan Fuhrman, program manager at A2LA, says this is a big milestone for ASA’s platform. “ISO/IEC 17065 and product certification can play a decisive role in the evolution of cannabis as medicine,” says Fuhrman. “With its high standards for competence and impartiality, adopting ISO/IEC 17065 represents a major win for healthcare providers and patients.”

Heather Despres, the director of ASA’s Patient Focused Certification program, says she is thrilled to be the first cannabis compliance organization to attain the accreditation. “The PFC program was developed by ASA in an effort to continue our commitment to protect patients, many of whom are medically fragile, and consumers who may be seeking medicine outside of conventional medicinal channels,” says Despres. “There is no other process that can demonstrate that continued commitment more than achieving ISO 17065 accreditation.”

Cannalytics Becomes First Accredited Cannabis Lab in Puerto Rico

By Cannabis Industry Journal Staff
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In a press release sent out this week, A2LA announced they have accredited Cannalytics to ISO 17025:2017. With the finalized accreditation in December 2020, Cannalytics is the first cannabis testing laboratory in Puerto Rico to get accredited to the standard.

Jorge Diaz, owner and director of Cannalytics, says their two main objectives are business excellence and quality. “Being the first ISO/IEC 17025 accredited cannabis laboratory in Puerto Rico affirms our mission to provide continuous quality science to our clients while safeguarding the health of Puerto Rico’s medical cannabis patients,” says Diaz.

Cannalytics is a medical cannabis and hemp testing lab based in San Juan, Puerto Rico. They offer compliance and R&D analysis in their suite of testing services.

“We are glad to see the continued growth of our cannabis program in a new territory, which further promotes the value that accreditation adds in ensuring quality in this emerging industry,” says Anna Williams, A2LA Accreditation Supervisor.

Trichome Analytical Accredited, DEA-Registered

By Cannabis Industry Journal Staff
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In a press release sent out this week, Trichome Analytical, based in Mount Laurel, New Jersey, announced two new developments for their business: They have achieved ISO 17025:2017 accreditation and they are officially registered with the DEA for hemp compliance testing.

The press release also mentions their collaboration with Shimadzu, who supplies 80% of the lab’s equipment and supports the Trichome’s operations with technical guidance.

For the hemp industry, pre-harvest testing for THC levels is a requirement and labs are required to get registered with the DEA in order to perform that testing.

These announcements are somewhat timely, given the results of the election. Voters in New Jersey approved adult use cannabis legalization just last week.

East Coast Cannalytics Accredited to ISO 17025

By Cannabis Industry Journal Staff
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In a press release published last week, the American Association for Laboratory Accreditation (A2LA) announced that they have successfully accredited East Coast Cannalytics (ECC) to ISO/IEC 17025:2017. ECC Labs, based in Blacksburg, Virginia, is an analytical and microbial testing lab.

The news is rather timely given Virginia’s recent efforts to reform their cannabis laws. Earlier this year, the state passed legislation legalizing medical cannabis and the very first dispensary in the state opened its doors in Bristol, VA last week.

According to Becky Hobden, CEO of ECC, their mission is to support the rapidly growing cannabis industry in Virginia and the greater Southeast. “ECC is thrilled to be ISO/IEC 17025 accredited! In the cannabis industry ISO/IEC 17025 is a beacon for labs that have rigorously validated methods and hold the highest standards for quality,” says Hobden. “As a leading cannabis lab in the southeast, we are honored to work with A2LA and demonstrate that we meet the quality standards set forth in ISO/IEC 17025. Thank you!”