Anytime a cannabis sample enters a laboratory, the sample is received, handled, weighed, identified and traced throughout the testing and disposal process. Laboratories working with cannabis must have quality systems in place to ensure every action taken to test the cannabis sample is documented and in compliance with good manufacturing practices. Eurofins-Experchem’s sample receipt and handling SOPs includes the following key elements.
- Purpose: The purpose of the SOP is outlined to make sure it’s outcome is understood
- Scope: The Scope of the SOP explains what events the SOP is intended to avoid and which events the SOP is intended to encourage
- Responsibilities: All positions that the SOP affects are outlined
- Initial Receipt of the Sample: Samples are submitted to Eurofins Experchem Laboratories with a Sample Information Form. In Canada, cannabis is regulated as a controlled substance. Controlled substances come with a special shipping document and must be weighed upon receipt to the lab to make sure the weight is the same as the client has indicated. Cannabis samples received are inspected to ensure no tampering or damage has occurred to the sample before it is tested. Any temperature and/or storage requirements are noted and followed. If any conditions are not understood the client is contacted for clarification immediately. Pending the sample’s conditions are met, the sample is placed into the laboratory.
- Procedure: Eurofins Experchem uses its own sample tracking software to track a sample across the lab. A unique project number and date of entry is given to the sample. Client name, product name, condition of sample, test(s) performed, ID or lot number and size of samples are all recorded. A sticker is attached to the sample to clarify.
- Rush Samples: Rush samples are stamped “RUSH” in red and are placed in a priority sequence. The sample is placed in the safe until required for testing. If the product is not cannabis, the sample is placed on a shelf corresponding with the actual day of the month it was received and entered into sample tracking. If the sample requires cold temperatures it is placed in a refrigerated area and monitored in a similar way.
- Discrepancies: Any discrepancies in information found on the sample that may differentiate from what the client requests will be communicated to the client upon finding.
- Controlled Documents: Stickers, original lab specification sheets, sample submission forms, and SOP training evaluation questionnaires.
- Results: As soon as testing is completed, lab results are approved by quality assurance reviewers. A Certificate of Analysis (COA) is electronically and automatically sent through the sample tracking system to the client’s email.
Eurofins-Experchem Laboratories is a Health Canada and FDA-accredited analytical laboratory with a regulatory support division. The laboratory carries out testing for many different sectors including pharmaceuticals, cosmetics, natural health products and medical devices. Starting in 2014, cannabis testing was incorporated into the mix. One reason our results so accurate is due to rigorous staff orientation and training method. Diligent staff training and monitoring is very important for success as a Good Manufacturing Practices (GMP) facility with a Drug Establishment Licence and Narcotics License. So what does that look like on the inside? Saif Al-Dujaili, our quality assurance manager, Sohil Mana, our vice president of operations, and I will provide some guidelines for developing training programs below.
- Introductory Session: When any new employee starts an introductory phase, it begins with general admin, a facility tour, policy manual training, govt. legislation overview and health and safety training and orientation (WHIMS and Bill 168) specific to our lab. We record signatures on any pertinent forms for SOPs that the new employee will be using.
- Standard Operating Procedures: Any new employee must read all related SOPs and is evaluated on their understanding of them through questionnaires/quizzes. SOPs are written for all equipment, instrumentation or process that is applied in the lab, to ensure consistency across operations.
- Laws and Regulations: New employees must be familiar or familiarized with Good Manufacturing Practices and Good Laboratory Practices. Analysts are required to read all sections of the USP pertinent to their role, as decided by the quality manager and/or dept. head and a checklist is recorded on training.
- Methods: Different methods are used to test products including Compendium or other published methods with organizations such as the Association of Analytical Communities (AOAC) and the American Chemical Society (ACS). Client Methods and house-developed methods are also used. If there is a change to any method, a change control form must be filled out and documented.
- Documentation: Documentation is very important in a GMP lab. All data is recorded in a hard cover bound book and/or approved worksheets. Quality assurance data reviewers are responsible for ensuring all data is being recorded properly.
- Sample Management: Employees are trained on sample management related to sample entry, how samples are distributed to analysts, turn-around time, and where finished projects are placed.
- Training Forms: Everything an employee learns must be recorded and filed for records. Analysts must follow a training matrix on qualitative and quantitative testing methods. Recurrent training occurs each 3 years or less depending on the position the analyst holds. Any updates on GMPs, new instruments or equipment is ongoing and recorded. Experchem runs “ghost” samples through its laboratory to ensure compliance by employees at any given time. Employees are evaluated on their abilities to comply.
- Ongoing Training: Once employees are up and running they also receive monthly training in the lab and an annual GMP training followed by a comprehensive quiz that must be passed for them to continue work.
Interested in learning more about cannabis testing in Canada and the US? Contact Tegan Adams, business development manager with Eurofins at firstname.lastname@example.org.
Editor’s Note: Eurofins-Experchem has helped submit over 150 MMPR applications to Health Canada and continues to work with 10 of the 27 licensed MMPR producers in Canada. Their regulatory affairs division has started working with companies applying to produce and distribute cannabis in those states, which are new to its sale and distribution. They offer services include writing SOPs, training staff and performing mock inspection audits.