64ER20-12 CMTL Certificate of Analysis.

1. (1) A CMTL must generate a Certificate of Analysis containing the results from each Final Product tested, containing all the information required in paragraph (a) below, and all the information required in paragraphs (b) and/or (c) below, as applicable. Additional information, analysis, or graphics not expressly required by paragraphs (a) through (c) may be included on any report required by this rule.

   1. (a) Certificates of Analysis for Environmental, Microbiological, and Cannabinoid Profile testing must contain:

      1. The name of the MMTC from which the sample was collected;

      2. The cultivation facility or facilities where the marijuana was cultivated;

      3. The processing facility or facilities where the marijuana was processed;

      4. The Cultivar or Cultivars making up the sample (If the Retail Batch is comprised of more than two Cultivars, the Testing Sample can be referred to as “mixed Cultivar”);

      5. The batch number and date the Retail Batch was created;

      6. The batch number and date any Laboratory Batch was created;

      7. The date sample preparation occurred;

      8. The total weight or volume of the Final Product received for testing;

      9. The internal Employee identification number of any person who performed the sample preparation;

      10. The date and time of the sample’s preparation;

      11. The title of the Standard Operating Procedure used to prepare the sample;

      12. The date and time sample analysis occurred; and

      13 The internal Employee identification number of any person who performed the sample analysis.

   2. (b) Certificates of Analysis for Environmental and Cannabinoid Profile testing must contain:

      1. The title of the Standard Operating Procedure used in the sample analysis;

      2. The type of instrument used to analyze the sample;

      3.The final weight or volume of the sample used in the analysis;

      4. The sample Matrix;

      5. The Target Analytes measured in the test;

      6. The numerical concentration for each Target Analyte measured in the Testing Sample and its Limit of Detection;

      7. The dilution factor of each Target Analyte;

      8. The percentage of each cannabinoid that must be tested and the total percentage of these cannabinoids within the sample; and

      9. Whether the sample has passed or failed in relation to Acceptable Limits for individual Target Analytes.

   3. (c) Certificates of Analysis for Microbiological Testing must contain:

      1. Presence or absence of microbes in 1 gram;

      2. Concentration of aflatoxins;

      3. Concentration of ochratoxin;

      4. The sample Matrix;

      5. The Target Analytes measured in the test;

      6. The Acceptable Limit for the analysis conducted; and

      7. Whether the sample passed or failed in relation to the Acceptable Limits for Microbes and Mycotoxins.

   4. (d) Certificates of Analysis generated by the CMTL to the MMTC within 14 days of the sample departure date noted on the chain of custody documentation.

2. (2) Data Packages. CMTLs must create and maintain Data Packages for every analyzed Laboratory Batch. Data packages must contain:

   1. (a) The name and address of the CMTL that performed the testing;
   2. (b) The name and address of the facility where the marijuana was cultivated;
   3. (c) The name and address of the facility where the marijuana was processed;
   4. (d) Internal Employee identification numbers of all Employees that performed any sample preparation, the sample analysis, or reviewed and approved the collected data;
   5. (e) Laboratory Batch Quality Control sample reports;
   6. (f) Raw data for each sample;
   7. (g) Instrument raw data, if any;
   8. (h) Instrument test method with parameters;
   9. (i) Instrument tune reports, where applicable;
   10. (j) All instrument Calibration and/or tune data;
   11. (k) Internal Standard report;
   12. (l) Initial Calibration Certification Report;
   13. (m) Continuing Calibration Verification Report;
   14. (n) Sample preparation worksheets;
   15. (o) Employee workbook sheets relevant to the analysis run;
   16. (p) Analytical Batch sample sequence; (q) Chain of custody documentation; and
   17. (r) A copy of any Certificate of Analysis required by subsection (1).

3. (3) Prior to the dissemination of any documentation contemplated by subsections (1) and (2) to the department or a MMTC, the CMTL’s Laboratory Director, or designee, must:

   1. (a) Review the quantitative analytical results for technical correctness and completeness;
   2. (b) Verify that the results of each analysis are accurately reported, and that the results can be traced back to the specific Laboratory Batch; and
   3. (c) Verify approval of the results by signing and dating the Data Package.
4. (4) CMTLs must maintain Data Packages for three (3) years from the date created. Chain of custody documentation, Initial Display of Competency documentation, MMTC audit reports, and MMTC onsite inspection reports must be retained for a minimum of three years from the date created. Quality Control reports and Proficiency Testing results must be retained for a minimum of two years from the date of receipt by the CMTL. Video surveillance recordings must be maintained for a minimum of 45 days or longer upon the request of a law enforcement agency or as ordered by any court of competent jurisdiction.

5. (5) Records. Upon request by the department, a CMTL must provide the department copies of the following within 48 hours of the department’s request:

   1. (a) Proof of accreditation required by CMTL rules;
   2. (b) All materials and documents submitted for the most recent ISO/IEC 17025 accreditation audit;
   3. (c) Standard Operating Procedures;
   4. (d) Analytical Methods;
   5. (e) Equipment logs;
   6. (f) Raw analytical data;
   7. (g) Initial Display of Competency documentation;
   8. (h) Chain of custody documentation;
   9. (i) Sample rejection logs;
   10. (j) Quality Assurance reports;
   11. (k) Proficiency Testing results;
   12. (l) Quality Assurance Manual;
   13. (m) Personnel qualification, training, and competency documentation;
   14. (n) Purchasing and supply records;
   15. (o) Method verification and validation records;
   16. (p) Quality Assurance and Quality Control records;
   17. (q) Equipment service records;
   18. (r) Non-conforming work and corrective action records;
   19. (s) Internal and external audit records;
   20. (t) Testing Facility and Secure Storage area security records;
   21. (u) Data Packages;
   22. (v) Data backup records;
   23. (w) Data reports, data review, and data approval records;
   24. (x) Any report or Certificate of Analysis created for a MMTC;
   25. (y) Any analytical testing data:
   26. (z) Traceability records;
   27. (aa) Standards records;
   28. (bb) Calibration records;
   29. (cc) Extraction logs, Certified Reference Materials records;
   30. (dd) Analyst notebooks and logbooks;
   31. (ee) Sample analysis reports;
   32. (ff) Contamination records;
   33. (gg) Cleaning records;
   34. (hh) Safety and chemical-hygiene records;
   35. (ii) Any other generated report related to the testing of marijuana;
   36. (jj) Any other generated report related to the audit or onsite inspection of MMTCs, to include any materials used in the creation of such report; and

   37. (kk) Any other document or record necessary to substantiate compliance with sections 381.986 and 381.988, F.S., and CMTL rules.

       

       

       

       

Rulemaking Authority 381.988(3), 381.988(9) FS. Law Implemented 381.988 FS. History–New 1-22-20.