Tag Archives: ISO

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.

How Effective is Your Internal Auditing Program?

By David Vaillencourt
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The word “audit” evokes various emotions depending on your role in an organization and the context of the audit. While most are familiar with and loathe the IRS’s potential for a tax audit, the audits we are going to discuss today are (or should be) welcomed – proactive internal quality audits. A softer term that is also acceptable is “self-assessment.” These are independent assessments conducted to determine how effective an organization’s risk management, processes and general governance is. 

“How do you know where you’re going if you don’t know where you’ve been” – Maya Angelou

Internal quality audits are critical to ensuring the safety of products, workers, consumers and the environment. When planned and performed periodically, these audits provide credible, consistent and objective evidence to inform the organization of its risks, weaknesses and opportunities for improvement. Ask yourself the question: do your clients/vendors rely on you to produce reliable, consistent and safe products? Assuming the answer is yes, what confidence do you have, and where is the documented evidence to support it?

Compliance units within cannabis businesses are typically responsible for ensuring a business stays legally compliant with state and federal regulations. This level of minimum compliance is critical to prevent fines and ensure licenses are not revoked. However, compliance audits rarely include fundamental components that leave cannabis operators exposed to many unnecessary risks.

Internal quality audits are critical to ensuring the safety of products, workers, consumers and the environment.

As a producer of medical and adult-use products that are ingested, inhaled or consumed in other forms by our friends, family and neighbors, how can you be sure that these products are produced safely and consistently? Are you confident that the legal requirements mandated by your state cannabis control board are sufficient? Judging by the number of recalls and frustrations voiced by the industry regarding the myriad of regulations, I would bet the answer is no.

What questions do internal audits address? Some examples include:

  • Are you operating as management intends?
  • How effective is your system in meeting specified objectives? These objectives could include quality metrics of your products, on-time delivery rates and other client/customer satisfaction metrics.
  • Are there opportunities to improve?
  • Are you doing what you say you do (in your SOPs), and do you have the recorded evidence (records) to prove it?
  • Are you meeting the requirements of all applicable government regulations?

There are potential drawbacks to internal audits. For one, as impartiality is essential in internal audits, it may be challenging to identify an impartial internal auditor in a small operation. If your team always feels like it is in firefighting mode, it may feel like a luxury to take the time to pull members out of their day-to-day duties and disrupt ongoing operations for an audit. Some fear that as internal assessments are meant to be more thorough than external assessments, a laundry list of to-do items may be uncovered due to the audit. But, these self-assessments often uncover issues that have resulted in operational efficiencies in the first place. This resulting “laundry list” then affords a proactive tool to implement corrective actions in an organized manner that can prevent the recurrence of major issues, as well as prevent new issues. The benefits of internal audits outweigh the drawbacks; not to mention, conducting internal audits is required by nearly every globally-recognized program, both voluntary (e.g. ISO 9001 or ASTM Internationals’s Cannabis Certification Program) and government required programs such as 21 CFR 211 for Pharmaceuticals.

Internal Auditing is a catalyst for improving an organization’s effectiveness and efficiency by providing insight and recommendations based on analyses and assessments of data and business processes. Additional benefits of internal audits include giving your organization the means to:

  • Ensure compliance to the requirements of internal, international and industry standards as well as regulations and customer requirements
  • Determine the effectiveness of the implemented system in meeting specified objectives (quality, environmental, financial)
  • Explore opportunities for improvement
  • Meet statutory and regulatory requirements
  • Provide feedback to Top Management
  • Lower the cost of poor quality

Findings from all audits must be addressed. This is typically done in accordance with a CAPA (Corrective Action Preventive Action) program. To many unfamiliar with Quality Management Systems, this may be a new term. As of Jan 1, 2021, this is now a requirement for all cannabis licensed operators in Colorado. Many other states require a CAPA program or similar. Continuing education units (CEUs) are available through ASTM International’s CAPA training program, which was developed specifically for the cannabis industry.

Examples of common audit findings that require CAPAs include:

  • Calibration – Production and test equipment must be calibrated to ensure they provide accurate and repeatable results.
  • Document and record control – Documents and records need to be readily accessible but protected from unintended use.
  • Supplier management – Most standards have various requirements for supplier management that may include auditing suppliers, monitoring supplier performance, only using suppliers certified to specific standards, etc.
  • Internal audits – Believe it or not, since internal audits are required by many programs, it’s not uncommon to have a finding related to internal audits! Findings from an internal audit can include not conducting audits on schedule, not addressing audit findings or not having a properly qualified internal auditor. Are you looking for more guidance? Last year, members of ASTM International’s D37 Committee on Cannabis approved a Standard Guide for Cannabis and Hemp Operation Compliance Audits, ASTM D8308-21.

If you are still on the fence about the value of an internal audit, given the option of an inspector uncovering a non-conformance or your own team discovering and then correcting it, which would you prefer? With fines easily exceeding $100,000 by many cannabis enforcement units, the answer should be clear. Internal audits are a valuable tool that should not be feared.

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.

QIMA/WQS to Audit Cannabis Companies as CSQ Certification Body

By Cannabis Industry Journal Staff
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Back in July of 2020, ASI Global Standards announced the launch of their newest audit standard: The Cannabis Safety & Quality Scheme (CSQ). The scheme is built around ISO requirements and the Global Food Safety Initiative (GFSI) requirements.

In a press release published in December of 2020, CSQ announced they have added a new licensed certification body to the program: QIMA/WQS, which is a provider of independent third-party certification, inspection, and training services for the food industry.

The CSQ program is marketed as the world’s first cannabis certification to meet GFSI criteria, which is expected to get benchmarked in 2022.

The CSQ scheme is built on four standards:

  • Growing and Cultivation of Cannabis Plants
  • Manufacturing and Extraction of Cannabis
  • Manufacturing and Infusion of Cannabis into Food & Beverage Products
  • Manufacturing of Cannabis Dietary Supplements

The first CSQ certifications are expected to be awarded this month. Being a licensed certification body for the CSQ program means QIMA/WQS will conduct document evaluations as well as on-site inspections to ensure companies are meeting the CSQ standards prior to certification.

“At QIMA WQS, we see an enormous potential to support and provide quality certification to the entire cannabis supply chain. Joining CSQ and its innovative approach is an exciting step into the diversification of our services and growth,” says Mario Berard, CEO of QIMA/WQS.

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.

Shimadzu Announces Partnership with Missouri Lab

By Cannabis Industry Journal Staff
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In a press release published last week, Shimadzu Scientific Instruments announced a partnership with MoCann Testing, a division of EKG Labs. MoCann Testing is the first state-certified medical cannabis testing lab in Missori.

It sounds like the partnership involves Shimadzu supplying MoCann with instruments and supporting their testing efforts with training, method development and maintenance, though the press release does not mention any details.

“We are excited to support MoCann’s mission to help individuals across the state of Missouri have access to safe medical marijuana through accurate sample testing and quality results,” says Bob Clifford, Ph.D., general manager of marketing at Shimadzu. “Because selecting the right analytical solutions is a critical investment, we provide more than just advanced instrumentation and software. We assist with method development, instrument training and maintenance that keep systems operating at the highest level.”

MoCann Testing is certified by Missouri, accredited to ISO 17025 and they offer the full gamut of testing services for growers and manufacturers in Missouri.

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!”