Tag Archives: personnel

Ask The Expert: Exploring Cannabis Laboratory Accreditation Part 4

By Aaron G. Biros
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In the first part of this series, we spoke with Michelle Bradac, senior accreditation officer at A2LA, to learn the basics of cannabis laboratory accreditation. In the second part, we sat down with Roger Brauninger, A2LA Biosafety Program manager, to learn why states are looking to lab accreditation in their regulations for the cannabis industry. In the third part, we heard from Michael DeGregorio, chief executive officer of Konocti Analytics, Inc., discussing method development in the cannabis testing industry and his experience with getting accredited.

In the fourth and final part of this series, we sit down with Susan Audino, Ph.D., an A2LA lead assessor and instructor, laboratory consultant and board member for the Center for Research on Environmental Medicine in Maryland. Dr. Audino will share some insights into method validation and the most technical aspects of laboratory accreditation.

Susan Audino, Ph.D.

Susan Audino obtained her Ph.D. in Chemistry with an analytical chemistry major, physical and biochemistry minor areas. She currently owns and operates a consulting firm to service chemical and biological laboratories. Susan has been studying the chemistry and applications of cannabinoids and provides scientific and technical guidance to cannabis dispensaries, testing laboratories and medical personnel. Dr. Audino’s interest most directly involves cannabis consumer safety and protection, and promotes active research towards the development of official test methods specifically for the cannabis industry, and to advocate appropriate clinical research. In addition to serving on Expert Review Panels, she is also chairing the first Cannabis Advisory Panel and working group with AOAC International, is a member of the Executive Committee of the ASTM Cannabis Section and has consulted to numerous cannabis laboratories and state regulatory bodies.

CannabisIndustryJournal: What are the some of the most significant technical issues facing an accreditation body when assessing a cannabis-testing laboratory?

Susan: From the AB perspective, there needs to be a high level of expertise to evaluate the merits and scientific soundness of laboratory-developed analytical test methods. Because there are presently no standard or consensus test methods available, laboratories are required to develop their own methods, which need to be valid. Validating methods require a rigorous series of tests and statistical analyses to ensure the correctness and reliability of the laboratory’s product, which is– the test report.

CIJ: When is method validation required and how does this differ from system suitability?

Susan: Method validation is required whenever the laboratory modifies a currently accepted consensus or standard test method, or when the laboratory develops its own method. Method validation is characterized by a series of analytical performance criteria including determinations of accuracy, precision, linearity, specification, limit of detection, and limit of quantitation. The determination of system suitability requires a series of deliberate variations of parameters to ensure the complete system, that is all instrument(s) as well as the analytical method, is maintained throughout the entire analytical process. Traditionally, method validation has been referred to as “ruggedness” and system suitability as “robustness.”

CIJ: What are the most important aspects of method validation that must be taken into account? 

Susan: In keeping with the FDA guidelines and other accepted criteria, I tend to recommend the International Conference on Harmonization (ICH), particularly Q 2A, which is a widely recognized program that discusses the pertinent characteristics of method validation. This include: method specification, linearity, range, accuracy, and precision (e.g., repeatability, intermediate precision, reproducibility). As mentioned earlier, system suitability is also a critical element and although related to method validation, does require its own protocol.

CIJ: What three areas do you see the laboratory having the hardest time with in preparing for accreditation? 

Susan: My responses to this question assume the laboratory employs appropriate instruments to perform the necessary analyses, and that the laboratory employs personnel with experience and knowledge appropriate to develop test methods and interpret test results.

  • By and large, method validation that is not appropriate to the scope of their intended work. Driving this is an overall lack of information about method validation. Oftentimes there is an assumption that multiple recoveries of CRMs constitute “validation”. While it may be one element, this only demonstrates the instrument’s suitability. My recommendation is to utilize any one of a number of good single laboratory validation protocols. Options include, but are not limited to AOAC International, American Chemical Society, ASTM, and ICH protocols.
  • Second is the lack of statistically sound sampling protocols for those laboratories that are mandated by their governing states to go to the field to sample the product from required batches. Sampling protocols needs to address the heterogeneity of the plant, defining the batch, and determining/collecting a sample of sufficient quantity that will be both large enough and representative of the population, and to provide the laboratory an adequate amount from which to sub-sample.
  • Third, sample preparation. This is somewhat intertwined with my previous point. Once an appropriate sample has been collected, preparation must be relevant to the appropriate technology and assay. It is unlikely that a laboratory can perform a single preparation that is amenable to comprehensive testing.
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Quality Controls and Medical Cannabis: What We Can Learn from Pharma

By Dr. Ginette M. Collazo
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When we discuss growing and producing medical cannabis, we must think of it as a medicine. By definition, it is a substance intended to assist you with a medical condition, to help you feel better and not harm you. Drugs produced in the pharmaceutical industry go through extensive quality controls to ensure a level of safety for the consumer or patient. Yet when we talk process and quality controls in medical cannabis production, there is still a lot to learn.

Are we waiting for the wake-up call? Well, ring! Recently Health Canada, the regulatory body overseeing Canada’s medical cannabis market, decided that “It will begin random testing of medical marijuana products to check for the presence of banned pesticides after product recalls affecting nearly 25,000 customers led to reports of illnesses and the possibility of a class action lawsuit.”

Proper quality controls help protect businesses from unforeseen issues like those massive recalls in Canada. These can assure that the product is safe (won’t harm you), has integrity (free of contamination), and that the product is what it says it is (identity). To achieve this important goal, we must have robust systems that will guarantee product quality. Why is this important? Quality controls can ensure a safer and more consistent product, helping build patient and consumer trust and brand loyalty, preventing a public relations nightmare like a recall due to pesticide contamination.

Food processing and sanitation
Product recalls due to manufacturing errors in sanitation cause mistrust among consumers.

The FDA, among other regulatory bodies, has established excellent guidelines to implement these controls. So there is a lot we can learn from the pharmaceutical industry and that FDA guidance regarding quality controls and assurance. After all, we are all interested in the same thing: a safe and effective product.

So, let’s take a look at some of the controls included in the CFR (Code of Federal Regulation), Part 211 , which include Good Manufacturing Practices (GMPs) for finished products, and how you can implement them in the growing business of growing cannabis.

  1. Personnel selection and training: The GMPs establish that “Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training… to enable that person to perform the assigned functions.” These include the creation of specific curricula per position and the establishment of requirements for specialized tasks. We all want to be successful so training, in this case, is what we call the vaccine for mistakes.
  2. Facilities: “Any building or buildings used in the manufacture, processing, packing, or holding of a drug product shall be of suitable size, construction, and location to facilitate cleaning, maintenance, and proper operations.” This requirement includes segregation of spaces to avoid cross-contamination, housekeeping, the cleaning process and detergent types, material storage conditions, humidity levels, temperature, water, and even ventilation requirements to prevent contamination with microorganisms. All with the intention of protecting the product.
  3. Pest control: “There shall be written procedures for the use of suitable rodenticides, insecticides, fungicides, fumigating agents, and cleaning and sanitizing agents. Such written procedures shall be designed to prevent the contamination of equipment, components, drug product containers, closures, packaging, labeling materials, or drug products and shall be followed.” There have been many issues pertaining this requirement. In 2010, Johnson & Johnson received many complaints claiming that the product had a musty, moldy odor. Later, the firm identified the cause of the odor to be a chemical, called 2, 4, 6-Tribromoanisole or TBA; a pesticide used to treat wooden pallets. One of the specific requirements of this section is to avoid the use of wooden pallets, but if you decide to use them, the method of sterilization by heat treatment seems like the only safe option for sterilizing wooden pallets and wood cases.
  4. Equipment/Instrumentation: “Equipment used in the manufacture, processing, packing, or holding of a drug product shall be of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and its cleaning and maintenance.” The intention is to not alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements. What would happen if lubricants/coolants or any other substance, not intended to be part of the product, comes in contact with the product?
  5. Procedures and documentation: “There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. Such procedures shall include all requirements of this subpart. These written procedures, including any changes, shall be drafted, reviewed, and approved. When we have followable, well written, clear, and specific procedures, we avoid possible errors that can get us in trouble.
  6. Defects Investigation: “Written production and process control procedures shall be followed in the execution of the various production and process control functions and shall be documented at the time of performance. Any deviation from the written procedures shall be recorded and justified.” We want to be successful, for that we need to learn from failures, understanding the root causes, correcting and preventing re-occurrence is what will keep you competitive. As you can see this requirement is essential for, quality, business and to evidence that such deviations did not adulterate the product.
  7. Process controls: Besides written procedures and deviations management, operation controls are pivotal in guaranteeing the quality as well as complete documentation of your process. These controls will vary depending on your technology and your product. If you do alcohol (ethanol) extraction, for example,  you want to keep an eye on the temperature, dissolution time, and even have color standards to be able to quickly and correctly identify possible abnormalities, while you can still correct the mistake. In-process product testing will allow you to monitor “performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the final product.”

Regardless of federal regulatory guidance, quality controls can be that one factor which can make or break your business. Why re-invent the wheel?