As of this writing, thirty states and Washington DC have passed laws legalizing medical marijuana; eight of those states have also legalized recreational use of marijuana. This shift in the US legal landscape has created an exciting new opportunity for entrepreneurs, investors, and even “ganjapreneurs” to create products, services, and companies that service the cannabis industry. One important part of the industry is testing and ensuring the quality of the cannabis being sold.
Both the DEA and state governments have made it clear that they want cannabis products to be tested for potency and purity before they are sold to consumers. The agency and states have made it clear that they want cannabis products to be tested for potency and purity before they are sold to consumers. But many laboratories that are accredited to perform this type of testing by the international standard organization for testing and calibration (ISO/IEC) are not equipped to test for pesticides, microbiological contaminants, and other issues that may affect cannabis.
What is the function of the quality control (QC) laboratory?
The quality control (QC) laboratory is one of the most important functions in the production of consumer goods. The quality control laboratory takes the final decision on the release of the products based on their compliance with the established specifications. Specifications establish a set of criteria that a product must meet to be considered acceptable for the intended use. The specifications are proposed, justified and adopted as part of an overall strategy to ensure the quality, safety and conformity of consumer products. Subsequently, the quality of consumer products is determined by design, development, Good Manufacturing Practice (GMP) control, product and process validation, and specifications applied during product development and manufacturing. These specifications shall include the specifically approved test methods and procedures and the acceptance criteria established for release and shelf life studies.
The Code of Federal Regulations, 21 CFR Part 211, Good Manufacturing Practices for Prepackaged Pharmaceuticals, contains minimum requirements for the manufacture of safe products for human or animal consumption. Specifically, 21 CFR part 211: Subpart I, Laboratory Controls, establishes quality control and drug testing requirements and expectations for laboratories. In addition, 21 CFR part 117, Current Good Manufacturing Practices, Hazard Analysis and Preventive Controls Based on Human Food Hazards: Subpart B – Processes and Controls – requires that appropriate quality controls be applied to ensure the safety of food for consumption and the safety and suitability of food packaging materials and components. Food and medicines should be tested against defined specifications to verify their quality and safety, and laboratories should have appropriate processes and procedures in place to support and protect the test results.
ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories, is used for the development and implementation of laboratory management systems. ISO/IEC 17025, originally known as ISO/IEC Guide 25 and first published in 1978, was created to recognise that third party certification systems [for laboratories] should be based as far as possible on internationally recognised standards and procedures. National accreditation bodies are responsible for the accreditation of laboratories according to ISO/IEC 17025. Accreditation bodies are responsible for assessing the quality system and technical aspects of the laboratory’s quality management system (QMS) against the requirements of ISO/IEC 17025. Accreditation against ISO/IEC 17025 is used by many laboratories to differentiate themselves from their competitors. In some cannabis markets, certification to the standard is mandatory.
The accreditation procedure according to ISO/IEC 17025 generally consists of a summary of the requirements of the standard using a checklist. Documentation is requested and reviewed to determine if the submitted documentation meets the checklist items directly related to the requirements of the standard. ISO/IEC 17025 covers requirements for testing and calibration laboratories. Given the wide variety of testing laboratories, the standard cannot and should not be overly specific about how the laboratory should meet the requirements. The goal of any laboratory seeking accreditation is to demonstrate that it has an established QMS. Equally important, especially for product testing laboratories, is the establishment of good practices (GxP) to ensure that test methods and laboratory procedures confirm the safety and quality of products. ISO/IEC 17025 is fundamental, but compliance with Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP) and even Good Safety Practice (GSP) is critical to the success of cannabis testing laboratories and to demonstrating the reliability and accuracy of test data.
If not accredited to ISO/IEC 17025
Compliance with ISO/IEC 17025 and subsequent accreditation is an excellent way of ensuring that laboratories have made an effort to establish a QMS. However, specifically for laboratories that test products, there are a number of gaps in the standard and in the accreditation process. Following are the five issues that I believe most affect a cannabis laboratory’s ability to maintain compliance and consistency, verify data integrity and reliability of analytical methods, and ensure the safety of laboratory personnel.
Standard operating procedures (SOPs)
Understanding what is considered a standard operating procedure (SOP) is often misunderstood by cannabis operators. An SOP is a clear set of step-by-step instructions that allow employees to perform routine tasks in a consistent manner. Documented SOP training confirms that employees understand their duties. Although not required by the current version of the standard, many laboratories develop a quality manual (QM). The QMS defines the organization’s quality policy, quality objectives, the QMS and the procedures that support the QMS. Cannabis laboratories often use the QM as a benchmark for their procedures. The purpose of the QM is to be a policy document for the company. KM is NOT a step-by-step guide, or at least it shouldn’t be.
Transfer of Test Methods (TMT)
Some cannabis labs develop their own testing methods, but many cannabis labs often purchase equipment from vendors that offer proven testing methods. Laboratories buy equipment, install it with pre-installed methods, and start testing products. There is no formal verification (called test method transfer (TMT)) by the laboratory to show that the method approved by the supplier will work equally well and produce valid results on the supplier’s equipment, by the supplier’s technicians and using the supplier’s standards and reagents, when the method is performed on their own equipment, by their own technicians and using their own standards and reagents. If inconsistencies or discrepancies are found in the results (most likely due to inadequate TMT), the test methods may be changed without justification or data to support the changes, and the next method will be the validated method used for testing the final version. The standard requires that the laboratory use validated methods. Most laboratories can easily produce documentation that meets this requirement. However, there is no evidence that the process for validating internal methods or transferring methods from suppliers was developed using a standard guide for validating test methods to confirm that the methods are accurate, precise, reliable, and reproducible. Therefore, changes in test methods do not need to be defined, documented and justified. These requirements are referred to in ISO/IEC 17025, step 7.2.2, Validation of methods, but they are written as guidance and not as an actual requirement for acceptance of accreditation.
The standard talks about identifying changes in documents and authorizing changes in software, but the standard and therefore the accreditation criteria do not prescribe that a process and procedure for change management must exist as part of the QMS. The laboratory does not have clear change management guidelines, including specific requirements for changes in test procedures and/or methods, documentation of the reasons for the changes, and identification of the individuals authorized to approve the changes.
Out of specification results (OOS)
Documenting and managing out-of-specification (OOS) test results is perhaps one of the most important obligations of cannabis testing laboratories. The standard requires a procedure for defective work. There is no mention of the need for a root cause analysis, no requirement to document actions and, most importantly, no requirement to document a plan for retesting, including a rationale for retesting. Compliance testing, as the practice is commonly known, was instituted by the FDA in the high-profile court case United States v. Barr Laboratories was declared inadmissible in 1993.
Safe laboratory practices are not addressed at all in ISO/IEC 17025. Most cannabis laboratories do not have a safety culture (as defined by the Occupational Safety and Health Administration (OSHA)). Policies and procedures should be developed that specify required personal protective equipment (PPE), safe handling of hazardous materials and spills, and a designated emergency evacuation plan. Gas chromatography (GC) is a common test method used in analytical laboratories. GC instruments require the use of compressed gas, which is usually supplied in gas cylinders. The proper handling, use and storage of gas cylinders should be specified. A preventive maintenance (PM) schedule should be established for eyewash stations, safety showers, and fire extinguishers. Finally, Material Safety Data Sheets (MSDS) should be printed and kept for reference by laboratory personnel.
ISO/IEC 17025 accreditation provides an additional level of trust, respect and assurance in the eyes of regulators and consumers. However, the current accreditation process does not allow for GxP, good laboratory practice. In my experience, cannabis labs that want to be accredited get some leniency because they have only been applying the standards for a short time. In my opinion, this does a disservice to cannabis laboratories and sets them up for failure in future accreditations and possible inspections by regulatory bodies. It is very important to guide owners and operators of cannabis laboratories from the outset and to ensure that they operate with the same rigour and control as other laboratories testing consumer products. Setting a precedent at the outset ensures uniformity, consistency and standardisation in an industry that desperately needs it.
- 21 Code of Federal Regulations (CFR) Part 211 – Good Manufacturing Practices for Prepackaged Drug Products.
- 21 Code of Federal Regulations (CFR) Part 117; Current Good Manufacturing Practices, Hazard Analysis, and Preventive Controls Based on Risk Assessment for Human Food : Subpart B – Processes and controls.
- ICH Q7 guidelines on good manufacturing practice for active pharmaceutical ingredients; laboratory controls.
- World Health Organization (WHO).
- International Building Code (IBC).
- International Fire Code (IFC).
- National Fire Protection Association (NFPA).
- Occupational Safety and Health Administration; Laboratories.
- ASTM D8244-21; Standard Guide for Analytical Operations in Support of the Cannabis and Horsemeat Industry.
- org; ISO/IEC 17025.
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