Ga. Comp. R. & Regs. R. 351-7-.04 - Independent Laboratory Operations

(1) An independent laboratory shall establish, maintain, and follow standard operating procedures, meeting the minimum standards set forth in these rules, detailing the performance of all methods employed by the facility used to test the analytes it reports, and made available for testing analysts to follow at all times.

(2) The standard operating procedures shall include, at a minimum, procedures for:

(a) Sample collecting;

(b) Sample increments;

(c) Sample receiving;

(d) Sample accessioning;

(e) Sample storage;

(f) Identifying and rejecting unacceptable samples;

(g) Recording and reporting discrepancies;

(h) Security of samples, aliquots, extracts, and records;

(i) Validating a new or revised method prior to testing samples to include:

1. Accuracy;

2. Precision;

3. Analytical sensitivity;

4. Analytical specificity (interferences);

5. Limit of Detection ("LOD");

6. Limit of Quantitation ("LOQ"); and

7. Verification of the reportable range.

(j) Aliquoting samples to avoid contamination and carry-over;

(k) Sample retention to assure stability, as follows:

1. For samples that comprise test batches submitted for testing other than pesticide contaminant testing, sample retention for fourteen (14) days; and

2. For samples that comprise test batches submitted for pesticide contaminant testing, sample retention for ninety (90) days.

(l) Disposal of samples and hazardous waste;

(m) The theory and principles behind each assay;

(n) Preparation and identification of reagents, standards, calibrators, and controls and ensure all standards are traceable to National Institute of Standards of Technology ("NIST");

(o) Special requirements and safety precautions involved in performing assays;

(p) Frequency and number of control and calibration materials;

(q) Recording and reporting assay results;

(r) Protocol and criteria for accepting or rejecting analytical procedure to verify the accuracy of the final report;

(s) Pertinent literature references for each method;

(t) 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;

(u) Acceptability criteria for the results of calibration standards and controls as well as between two (2) aliquots or columns;

(v) A documented system for reviewing the results of testing calibrators, controls, standards, and subject tests results, as well as reviewing for clerical errors, analytical errors, and any unusual analytical results; and

(w) Laboratory and sample contamination prevention.

(3) The independent laboratory director or agent shall approve, sign, and date each procedure. If any modifications are made to those procedures, then the independent laboratory director or agent shall approve, sign, and date the revised version prior to use.

(4) The independent laboratory's standard operating procedures shall be kept on the independent laboratory premises, be accessible to all employees during all hours of operation, and be made available upon request to the Commission or its employees.

(5) An independent laboratory shall establish, monitor, and document on an ongoing basis the quality control measures taken by the independent laboratory to ensure the proper functioning of equipment, validity of standard operating procedures, and accuracy of results reported. Such quality control measures shall include the following, at a minimum:

(a) Documentation of instrument preventive maintenance, repair, troubleshooting, and corrective actions taken when performance does not meet established levels of quality;

(b) Review and documentation of the accuracy of automatic and adjustable pipettes and other measuring devices when placed into service and annually thereafter;

(c) Cleaning, maintaining, and calibrating as needed the analytical balances, and in addition, verifying the performance of the balance annually using certified weights to include three (3) or more weights bracketing the ranges of measurement used by the independent laboratory;

(d) Annually verifying and documenting the accuracy of thermometers using a NIST traceable reference thermometer;

(e) Recording temperatures on all equipment when in use where temperature control is specified in the standard operating procedures, such as water baths, heating blocks, incubators, ovens, refrigerators, and freezers;

(f) Properly labeling reagents as to the identity, concentration, date of preparation, storage conditions, lot number tracking, expiration date, and identity of the preparer(s);

(g) Avoiding mixing different lots of reagents in the same analytical run;

(h) Performing and documenting a calibration curve with each analysis using, at minimum, five (5) calibrators throughout the reporting range;

(i) For qualitative analyses, analyzing, at minimum, a negative and a positive control with each batch of samples analyzed;

(j) For quantitative analyses, analyzing, at minimum, a negative and two (2) levels of controls that challenge the linearity of the entire curve;

(k) Using a control material or materials that differ in either source, lot number, or concentration from the calibration material used with each analytical run;

(l) For multi-analyte assays, performing and documenting calibration curves and controls specific to each analyte, or at minimum, one with similar chemical properties as reported in the analytical run;

(m) Analyzing an appropriate matrix blank and control with each analytical run, when available;

(n) Analyzing calibrators and controls in the same manner as unknowns;

(o) Documenting the performance of calibration standards and controls for each analytical run to ensure the acceptability criteria as defined in the standard operating procedure is met;

(p) Documenting all corrective actions taken when unacceptable calibration, control, and standard or instrument performance does not meet acceptability criteria as defined in the standard operating procedure;

(q) Maintaining records of validation data for any new or modified methods to include; accuracy, precision, analytical specificity (interferences), LOD, LOQ, and verification of the linear range; and

(r) Performing validation testing to ensure that current standard operating procedures are followed for the test or tests to be performed.

(6) The independent laboratory shall conduct an internal audit at least once per year or in accordance with the accrediting body's requirements for such laboratory's ISO/IEC 17025:2017 (or higher) accreditation, whichever interval occurs more frequently, and submit the results of the internal audit to the Commission and its employees within three (3) days of completing the internal audit.

(7) An independent laboratory shall ensure adequate training will be provided to every employee who performs a task, or set of tasks, referenced in the standard operating procedures.

(8) An independent laboratory is prohibited from testing product in final packaged form or providing results to a production licensee during the time that its accreditation is lost or suspended.

(a) An independent laboratory shall reestablish accreditation within one hundred eighty (180) days of the effective date of the loss or suspension of accreditation. If an independent laboratory fails to reestablish its accreditation within one hundred eighty (180) days of the loss or suspension, then the independent laboratory's registration shall become invalid and the respective laboratory shall be removed from the Commission's list of approved independent laboratories for the purpose of testing regulated cannabis.

(b) An independent laboratory shall notify the Commission and its employees of the reestablishment of its accreditation within twenty-four (24) hours of the effective date of reaccreditation.

Notes

Ga. Comp. R. & Regs. R. 351-7-.04

O.C.G.A. §§ 16-12-203, 16-12-210, 16-12-217.

Original Rule entitled "Independent Laboratory Operations" adopted. F. Mar. 16, 2023; eff. Apr. 5, 2023.