Rule 351-4-.06 - Quality Control Procedures(1) Prior to distributing or transporting product in final packaged form to a dispensary or pharmacy, a production licensee shall ensure the following: (a) The production licensee contracts with and uses an independent laboratory listed on the Commission's list of approved independent laboratories as set forth in Code Section 16-12-217(b) for sample collection and testing;(b) The manufactured batch has passed all required testing and has been issued a passing certificate of analysis; and(c) Retest product in final packaged form, prior to or upon expiration of an existing and passing certificate of analysis, to ensure such product continues to pass all required testing.(2) For the collection of controlled samples on the production licensee's premises, a production licensee shall ensure the following: (a) Such samples are collected by a sample collector from an independent laboratory on the premises, in the presence of an employee of the licensee and in full view of security cameras; and(b) During such collection, the sample collector has the ability to randomly collect such samples from the entire manufactured batch so that each unit from such batch has the same probability of being selected.(3) For the selection and retention of reserve samples on the production licensee's premises, a production licensee shall ensure that such samples are: (a) Selected by a sample collector from an independent laboratory in the presence of an employee of the licensee and in full view of security cameras;(b) Selected by such collector at the same time, place, and manner as the collection of controlled samples from the same manufactured batch; and(c) Retained, labeled, stored, and secured by such licensee on the premises for a minimum of twelve (12) months after a certificate of analysis is issued.(4) If a sample of product in final packaged form is tested by an independent laboratory, and such sample passes the required testing, then the sample results shall be valid for twelve (12) months from the date on the certificate of analysis.(5) If a sample of product in final packaged form is tested by an independent laboratory, and such sample fails the required testing, then upon notice or knowledge of such results, the production licensee shall physically quarantine the entire respective, manufactured batch in a sealed package that prevents cross-contamination and is labeled in a manner that indicates the batch failed required testing. In such circumstances, the production licensee may proceed in any and all of the following manner: (a) Refute the testing results and request no more than two (2) reanalyses for the same manufactured batch. Such two (2) reanalyses may be conducted using the failed controlled sample or another controlled sample from the same manufactured batch, the latter of which shall meet the requirements set forth in this rule.(b) Remediate the manufactured batch and ensure that:1. The collection of controlled samples and the selection and retention of reserve samples for the remediated batch follow the corresponding requirements set forth in this rule;2. Prior to being removed from such quarantine, the controlled samples of the remediated batch undergo and pass two (2) separate tests, with the second of such two (2) tests to be conducted within twenty-four (24) hours of receipt of a passing certificate of analysis for the first of such two (2) tests; and3. The batch remediation process is documented and such records include the relevant manufactured batch number, the date of remediation, the process of remediation, and the persons involved in the remediation process.(c) Dispose of the manufactured batch as set forth in Rule 351-4-.05.(6) A production licensee shall ensure all samples submitted for testing are entered into the Commission-approved tracking system and properly reflected in inventory totals.(7) A production licensee shall ensure all product in quarantine are entered into the Commission-approved tracking system and properly reflected in inventory totals.(8) A production licensee shall establish, maintain, and follow standard operating procedures to ensure quality control and quality assurance in producing and manufacturing products in final packaged form. Such procedures, and changes to such procedures, shall be maintained on the premises and made available to the employees of such licensee.Ga. Comp. R. & Regs. R. 351-4-.06
O.C.G.A. §§ 16-12-203, 16-12-210, 16-12-211, 16-12-212, 16-12-213, 16-12-217.
Original Rule entitled "Quality Control Procedures" adopted. F. Mar. 16, 2023; eff. Apr. 5, 2023.Amended: F. Nov. 9, 2023; eff. Nov. 29, 2023.