Compilation of Rules and Regulations of the State of Georgia › Department 351 - GEORGIA ACCESS TO MEDICAL CANNABIS COMMISSION › Chapter 351-7 - INDEPENDENT LABORATORIES › Rule 351-7-.01 - Independent Laboratory Registration and Renewal

Current through Rules and Regulations filed through June 27, 2024
(1) An independent laboratory shall be approved by the Commission prior to
								 testing product in final packaged form from production licensees. The Commission hereby delegates the
								 authority and responsibility to approve or deny registration forms submitted by independent laboratories to
								 the GMCC Executive Director.
(2) To request approval by the
								 Commission, the requesting independent laboratory shall submit the following to the Commission:
(a) A complete independent laboratory registration form as required by the
								 Commission;
(b) The required non-refundable registration fee as
								 listed on the fee schedule;
(c) The legal name of the independent
								 laboratory as reflected in the articles of incorporation or organizational documents filed with the Georgia
								 Secretary of State, including:
1. The type of corporation or entity of the
								 independent laboratory;
2. A copy of the independent laboratory's
								 articles of incorporation, articles of organization, or partnership document; and
3. The trade name of the independent laboratory, if applicable and if
								 different from the legal name.
(d) The physical
								 address, county, and global positioning satellite coordinates where the independent laboratory is
								 located;
(e) The U.S. Postal Service mailing address of the
								 independent laboratory;
(f) The name(s) of the independent
								 laboratory owner(s) and the director or agent;
(g) The telephone
								 number(s) of the independent laboratory director or agent;
(h)
								 The electronic mail address of the independent laboratory director or agent;
(i) A copy of the secure and verifiable document as set forth in Code
								 Section  50-36-2 for the independent laboratory owner;
(j) Attestation that, upon registration with the Commission, the
								 independent laboratory will maintain compliance with all local ordinances, rules, or regulations adopted by
								 the locality where the independent laboratory is located, which are in effect at the time of submitting the
								 registration form, including copies of any required local registration, license, or permit of the locality
								 where the independent laboratory is located;
(k) Documentation
								 related to a certificate of accreditation for International Organization for Standardization
								 ("ISO")/International Electrotechnical Commission ("IEC") 17025:2017 or higher:
1. A copy of such certificate for each required testing field as set forth
								 in Rule  351-7-.08; or
2. Records
								 demonstrating that such certificate for each required testing field as set forth in Rule
								  351-7-.08  has been applied for, including all of the following:
(i) A copy of the application to the accrediting body for ISO/IEC
								 17025:2017 (or higher) accreditation;
(ii) Documentation of the
								 payment receipt(s) for accreditation with the accrediting body;
(iii) Documentation acknowledging receipt of the application and payment(s)
								 by the accrediting body;
(iv) Tentative schedule of any remaining
								 steps in obtaining such certificate, including supporting documentation; and
(v) Documentation from the accrediting body for all accreditation audit(s),
								 including dates and status, that have been scheduled and completed.
(l) A copy of the United States Department of Justice, Drug Enforcement
								 Administration Controlled Substances Act Certificate of the independent laboratory.
(m) A current copy of its standard operating procedures which shall
								 address, at a minimum, the following:
1. Oversight of the independent
								 laboratory, including, but not limited to, documentation of the reporting and management structure of the
								 independent laboratory;
2. Accurate record keeping;
3. Employee safety and security;
4. Safety and security plans, including a disaster plan with procedures to
								 be followed in case of fire or other emergencies;
5. Secure
								 transportation plan and techniques for crime prevention;
6. A job
								 description or employment contract developed for all employees which includes duties, responsibilities,
								 authority, qualification, and supervision;
7. Alcohol and
								 drug-free workplace policies;
8. Storage of product in final
								 packaged form prior to testing which ensure product quality and efficacy are maintained;
9. Testing of product in final packaged form, including:
(i) Each batch of product in final packaged form produced by a production
								 licensee; and
(ii) Product in final packaged form from a
								 dispensing licensee, when necessary.
10. A detailed
								 description of how the product in final packaged form will be tested, including:
(i) The process detailing how samples are collected by the independent
								 laboratory;
(ii) The number of samples tested;
(iii) The size of sample tested;
(iv) The tests conducted;
(v)
								 Creation and reporting of the certificate of analysis to the production licensee;
(vi) Reporting results to the Commission; and
(vii) Disposal of samples.
11. An inventory of equipment and the methods used for the testing of
								 product in final packaged form to detect the following for a certificate of analysis as set forth in Rule
								  351-7-.08:
(i) Potency;
(ii) Cannabinoid profile;
(iii)
								 Heavy metals;
(iv) Pesticides;
(v) Residual solvents;
(vi)
								 Visible foreign material;
(vii) Microbiological contaminants and
								 mycotoxins; and
(viii) Terpenes.
(n) Attestation that the registration form and its required documentation
								 are true and current at the time of submission to the Commission and its employees.
(o) Other information upon request by the Commission or its
								 employees.