15 Miss. Code. R. 22-5.10

Current through August 31, 2024

Section 15-22-5.10 - Quality Assurance Measures for Cannabis Testing Entities

5.10.1 The cannabis testing entity shall develop and implement a Quality Assurance (QA) program to assure the reliability and validity of the analytical data produced by the cannabis testing entity. The QA program shall, at minimum, include a written QA manual that addresses the following:

A. Quality control procedures;

B. Cannabis testing entity organization and employee training and responsibilities, including good laboratory practice (GLP);

C. QA objectives for measurement data;

D. Traceability of data and analytical results;

E. Instrument maintenance, calibration procedures, and frequency;

F. Performance and system audits,

G. Corrective action procedures;

H. Steps to change processes when necessary;

I. Record retention and document control;

J. Test procedure standardization; and

K. Method validation;

L. Chain of custody protocols;

M. Premise and sample security;

N. Sample handling, including sample receipt, identification, rejection, storage and destruction;

O. Contingency plans for data that is not within control limits, or is otherwise unacceptable for analysis; and

P. Disposal of cannabis and laboratory waste.

5.10.2 The supervisory or management cannabis testing entity employee shall annually review, amend if necessary, and approve the QA program and manual both when they are created and when there is a change in methods, testing entity equipment, or the supervisory or management testing entity employee.

5.10.3 The cannabis testing entity's standard operating procedures for testing methods shall include the following:

A. The name of the testing method;

B. A list of all analytes used in the testing method;

C. The applicable matrix or matrices;

D. Sample receipt and acceptance;

E. Method sensitivity;

F. Potential interferences;

G. Analytical instrument and equipment used;

H. Consumable supplies, reagents, and standards;

I. Sample preservation and hold time;

J. Type, frequency, and acceptable criteria for quality control samples;

K. Type, frequency, and acceptable criteria for calibration standards;

L. Procedures for analyzing batch samples;

M. Data quality assessment and acceptance criteria;

N. Calibration of results; and,

O. Reagent solution and reference material preparation.

P. Current step-by-step instructions with sufficient detail to perform the assay to include equipment operation and any abbreviated versions used by a testing analyst.

5.10.4 Each cannabis testing entity shall maintain a consumables log or inventory for all reagents, reference standards and media purchased and received. All reagents and reference standards, including any working standards, must be:

A. Labeled to indicate identity, batch number, date received or prepared, expiration date, and where applicable, concentration or purity, and date opened;

B. Stored under appropriate conditions to minimize degradation or deterioration of the material;

C. Within their expiration or re-qualification dates at the time of use; and,

D. Documented on records for each analysis.

5.10.5 Each cannabis testing entity shall calibrate and maintain its equipment as specified below, and the calibration, verification and/or check and maintenance must be documented.

A. Trend testing space temperatures and humidity daily using NIST-certified temperature devices. Record corrective action if temperatures are out-of-range.

B. Check autoclaves performance with bioindicator monthly and use heat-indicating tape with each cycle.

C. Check automatic Pipettes or Micropipettors and Pipette Tips dispensing accuracy and precision quarterly and calibrate annually.

D. Check balances daily with a documented zero before use and service and recalibrate annually.

E. Inspect Biosafety cabinet airflow with each use and have certified annually.

F. Clean blenders as required by manufacturer after each homogenization of submitted cannabis or cannabis products.

G. Verify centrifuge speeds and temperatures daily and have certified annually.

H. Calibrate conductivity monthly.

I. Trend freezer and refrigerator temperatures daily using NIST-certified temperature devices. Record corrective action if temperatures are out-of-range.

J. Inspect glassware for chemistry cannabis testing entity with each use for cleanliness, chips, and etching with each use. Use class A when specified by the approved method and keep certificate of conformance per each piece of class A glassware. If class B or class A without a certificate of conformance, perform verification check upon purchase or prior to first use.

K. Inspect glassware for microbiological cannabis testing entity with each use for cleanliness, chips, and etching.

L. Trend incubator temperatures daily using NIST-certified temperature devices. Record corrective action if temperatures are out-of-range.

M. Trend water bath temperatures daily using NIST-certified temperature devices. Record corrective action if temperatures are out-of-range.

N. Trend Laminar Flow Hoods daily and service annually.

O. Clean Microscope optics and stage daily and check alignment with each use. Service annually.

P. Follow Microwave digestors manufacturer's instructions.

Q. Check Muffle furnaces temperature accuracy at least annually.

R. Standardize pH meters with at least 2 buffer solutions daily before use.

S. Check Spectrophotometers wavelength.

T. Check Timers and stop watches at least annually.

U. Certify reference weights annually.

V. Follow Analytical Instrumentation manufacturer's instructions for cleaning and maintenance and document all cleaning, calibrations, maintenance, and repairs.

W. Maintain all service records for the life of equipment.

5.10.6 The cannabis testing entities shall develop, implement, and validate test methods for the analyses of samples as follows:

A. To the extent practicable, methods shall compart with the following guidelines:

B. The Bacteriological Analytical Manual (BAM), 2019, which is incorporated by reference, includes no future editions or amendments, and is available at https://www.fda.gov/food/laboratory-methods-food/bacteriological-analytical-manualbam;

C. AOAC Official Methods of Analysis, 21st Edition, 2019, which is incorporated by reference, includes no future editions or amendments, and is available at https://www.aoac.org/official-methods-of-analysis-21st-edition-2019; and

D. To the extent practicable, methods shall be validated in accordance with the following guidelines:

1. AOAC - Appendix J: Guidelines for Validation of Microbiological Methods for Food and Environmental Surfaces, 2012, which is incorporated by reference, includes no future editions or amendments, and is available at http://www.eoma.aoac.org/app_j.pdf [File Link Not Available];

2. AOAC - Appendix K: Guidelines for Dietary Supplements and Botanicals, 2013, which is incorporated by reference, includes no future editions or amendments, and is available at http://www.eoma.aoac.org/app_k.pdf [File Link Not Available];

3. ICH - Validation of Analytical Procedures: Text and Methodology Q2(R1) 2005, which is incorporated by reference, includes no future editions or amendments, and is available at https://database.ich.org/sites/default/files/Q2_R1__Guideline.pdf [File Link Not Available] or Unofficial version of the Rules in 9 A.A.C. 17, effective September 8, 2022 Page 115 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q2-r1-validation-analytical-procedures-text-and-methodology.

E. Method validation should, at a minimum, verify accuracy, precision, analytical sensitivity, analytical specificity, limit of detection, limit of quantification, reportable range and the identification of interfering substances.

F. Methods adopted from a matrix specific standard method, inclusivity and exclusivity do not require a comprehensive reassessment, provided that there were no modifications to the methods, including, but not limited to, all of the following:

1. Referenced media.

2. Primers.

3. Probes.

4. Antibodies.

5. Critical chemistries that were not modified.

6. Microbial methods shall include environmental monitoring and quality control of all buffers, media, primers, and incubators.

G. The licensed laboratory shall generate a validation report for each test method. Each validation report shall include the following information:

1. Instrument calibration data, if any;

2. Raw data, including instrument raw data scanned as a PDF, for each test method, if any;

3. Cannabis reference materials or certified reference material results;

4. Data and calculations pertaining to LOD and LOQ determinations, if any;

5. Quality Control Sample report;

6. Worksheets, forms, pictures, or copies of laboratory notebook pages

H. The laboratory director shall review, approve, sign, and date the validation report for each test method.

I. Validations shall be submitted to the agency for approval with an acceptable and graded external proficiency test by a third party, where all required analytes are shown to have passed.

J. Upon new test methods or altered test methods being used in the laboratory, the new validation report shall be submitted to the Department within 5 business days.

15 Miss. Code. R. 22-5.10

Adopted 1/13/2024