Tag Archives: ISO

MRAs

The Role of 3rd Party Accreditation in Cannabis Safety

By Roger Brauninger
1 Comment
MRAs

Living in a world of ever-increasing interdependence and an era of limited state government, financial and human resources, it is imperative that those charged with protecting the health and safety of patients and users of medical and recreational cannabis products leverage what private sector institutions and existing frameworks already offer in setting up quality standards for laboratory testing operations. That this moment arrives now – at a point where state governments are being tasked with undertaking the most significant change in the regulation of this substance whilst the federal government appears unwilling to play a substantial role – makes this partnership both inevitable and absolutely necessary.

Accreditation is an internationally accepted conformity assessment tool for ensuring laboratory competence and confidence in the accuracy and reliability test data. The accreditation infrastructure is well-established through accreditation bodies (ABs) and the Mutual Recognition Arrangement (MRA) of the International Laboratory Accreditation Cooperation (ILAC), supported by regional cooperative arrangements, including those of the Asia Pacific Laboratory Accreditation Cooperation (APLAC) and the Inter-American Accreditation Cooperation (IAAC). ILAC functions as a forum for harmonization of laboratory accreditation procedures and policies, thus reducing technical barriers to trade and promoting laboratory accreditation as a mechanism for establishing confidence in testing facilities. ILAC MRA signatory ABs are recognized, through a rigorous peer evaluation process, as competent to accredit testing organizations. All signatory ABs must meet the requirements of ISO/IEC 17011 and use ISO/IEC 17025 as the basis for accreditation of laboratories. In turn, under the ILAC MRA and the regional co-operations, competent laboratories are recognized globally, thus facilitating acceptance of the test results that accompany goods across international borders.

MRAs
A map showing the mutual recognition agreements across the globe

In other areas, such as the food supply and energy, both state and federal government have been an active participant in accreditation activities. According to The Administrative Conference of the United States in its Agency Use of Third-Party Programs to Assess Regulatory Compliance*, “…agencies in diverse areas of regulation have developed third-party programs to assess whether regulated entities are in compliance with regulatory standards and other requirements. Through these programs, third parties are charged with assessing the safety of imported food… Third parties also ensure that products labeled as organic and energy-efficient meet applicable federal standards. In these regulatory third-party programs, regulated entities generally contract with third parties to carry out product testing and other regulatory compliance assessment activities in the place of regulatory agencies. Regulatory agencies take on new roles in coordinating and overseeing these third-party actors.” While this reference largely deals with areas outside of cannabis regulation, it remains useful and relevant because of the manner in which cannabis products are used.

Traditionally, ABs have worked with regulators to establish specific technical requirements to supplement the ISO/IEC 17025 accreditation framework. In this partnership, the AB is responsible for executing the assessment and accreditation process but the regulator retains responsibility for the ultimate decisions on the acceptance of that organization’s accreditation. In the example of our food supply and its various sources, governmental recognition of accreditation bodies operating in accordance with international standards is much more practical than government agencies themselves accrediting the individual testing organizations or ABs. Thus the public/private partnership paradigm: To assess regulatory compliance a Regulatory Agency approves ABs that accredit organizations that assess whether Regulated Entities or Regulated Products are in conformity with a Regulatory Standard.*

In this example, all of the organizations are treated equally by the regulatory agency since they use the same recognition criteria for ABs and the same accreditation requirements in the assessment of conformity assessment bodies. This approach would also provide consistency at a point in time where many states are grappling with trying to find the best quality standard to use and which, to date, has resulted in many different standards being chosen or considered for implementation. This is especially true when one looks at the requirements put into place by the “early adopter” states. However, in those states that have entered this area more recently, it seems clear that the consensus is use of ISO/IEC 17025 as the most appropriate quality management standard for testing laboratories.

Seth_Wong_headshot
From The Lab

What to Consider When Selecting a Laboratory

By Seth Wong
No Comments
Seth_Wong_headshot

There are many factors to consider when selecting a third party analytical laboratory:

  • Why are you testing?
  • Does a governing body require it?
  • Are you testing to meet compliance with industry trends?
  • Are you testing as supplemental protection to an in house laboratory operation?
  • Are your results being used to help you market your product?
  • Are the results being utilized for internal R&D?
  • What are you looking to get out of testing?

Perhaps it is a combination of all these things. Regardless, whomever you contract with for whatever reasons, it is important to understand what you are getting, know what you are entitled to, understand your results, and understand where you and your company remain vulnerable. You must also be prepared with a plan to handle adverse results. Testing at a third party analytical contract laboratory does not mean they assume all of your product’s or company’s liability, regardless of the lab’s reputation.

Ask your third party laboratory about any accreditations, certifications, and licenses that the lab should be accredited and/or certified for. Each state has different certifications and licensing requirements; make sure the entity you are using is licensed or certified for the services you need. Additionally, there is an accreditation called International Standards Organization (ISO) 17025 that is the pinnacle of third party laboratory accreditation. ISO 17025 is a set of protocols that your third party lab should follow to do everything it can to ensure your data is accurate and produced with reliable standards, control samples, matrix control samples and proficiency tests to verify the accuracy of the lab’s employees and methods, among a number of other criteria included in the standard. A number of different entities offer accreditation to ISO 17025 but it is important that the the accrediting body is also accredited to their ISO standard. Simply buying ISO 17025 compliant materials or standards does not mean that the vendor service or product is accredited to ISO 17025. Cannabis laboratories are just starting to implement and build systems around ISO 17025 but it has been prevalent in the third party lab business in many industries for decades and should be applied to the cannabis industry.

Visit your lab and understand their background and experience. Start by requesting a tour of the laboratory you choose; you want to know how things look behind the scenes. Is the lab orderly and doing its best to protect sample integrity? There may be a lot of things going on in the laboratory and it may look chaotic but it should be relatively clean. This prevents contamination and sample mix-ups. Further your relationship with your laboratory by understanding the laboratory’s experience and getting to know your laboratory staff. Consider the lab staff as part of your extended team, they are there to help you and help bring your product to market. The more they understand your goals, the more they can help.

Understand your lab’s history and background: Have they worked with products and/or analytes similar to yours? Have they worked with your sample matrix or one similar to it before? Their prior knowledge and laboratory experience, as it relates to your product, will help provide accurate data and navigate complex matrices.

Most importantly, a laboratory should be willing to release the data packet that is used to generate test results to the client. Releasing this data does not divulge any proprietary information of the lab. It is the laboratory’s job to provide you with the data upon request. It is important to note, looking at your raw data is not the same as looking at the laboratory method, also known as a work instruction or operating procedure. The lab most likely won’t give you the method as those are typically trade secrets, but there is no reason not to share with you the chromatography that the HPLC, GC, GC/MS, or LC/MS generated. This will demonstrate the lab’s sound analytical data and increase your confidence in the analysis you are receiving. When you pay for the results, you are also paying for your data and if your laboratory is not releasing that information to you at your request, you should be skeptical. This data needs to be able to stand up to audits and legal action.

Finally, confidentiality: your data is your data. Yes, you may have to report results to a governing body, but your laboratory should not be sharing your name and your data with anyone but your authorized list of contacts without your permission. They should not even disclose that you are their client without your prior authorization. Confidentiality is not just applicable to a few key employees at the laboratory, it is pertinent to everyone from the sample pickup driver, if you have one, to the chemists and upper level management.

Understanding your contract laboratory’s certifications, licenses, and accreditations, requesting and receiving raw data packages, and ensuring that you feel comfortable with the laboratory, its staff and their practices are key elements to ensuring a successful relationship with your laboratory.