Haw. Code R. § 11-850-128 - Recordkeeping for quality control

(a) A medical cannabis dispensary shall establish and maintain the following records documenting compliance with this subchapter:

(1) Written procedures for quality control operations, including:

(A) Conducting a review and making a disposition decision;

(B) Approving or rejecting any reprocessing;

(C) Identifying and investigating additional potentially implicated batches;

(D) Handling of returned cannabis or manufactured cannabis products, including procedures for quarantine, destruction, and salvaging and reprocessing; and

(E) Reviewing and investigating product complaints;

(2) Written documentation, at the time of performance, that quality control personnel performed the review, approval, or rejection requirements by recording the following:

(A) Date that the review, approval, or rejection was performed; and

(B) Signature of the person performing the review, approval, or rejection;

(3) Documentation of any quality control review and disposition decision and follow-up shall be included in the appropriate batch production record and shall include:

(A) Identification of the specific deviation or unanticipated occurrence;

(B) Description of the investigation into the cause of the deviation or unanticipated occurrence;

(C) Evaluation of whether or not the deviation or unanticipated occurrence has resulted in or could lead to a failure to ensure the quality of the cannabis or manufactured cannabis product;

(D) Identification of the action (s) taken to correct, and prevent a recurrence of, the deviation or unanticipated occurrence;

(E) Explanation of what was done with the cannabis, manufactured cannabis product, packaging, or label;

(F) A scientifically valid reason for any reprocessing of a manufactured cannabis product that is rejected; and

(G) The signature of the individual(s) designated to perform the quality control operation, who conducted the review and made the disposition decision, and of each qualified individual who provides information relevant to the review and disposition decision;

(4) The results of any laboratory analyses conducted as part of a quality control review or product complaint investigation;

(5) Documentation of the re-evaluation by quality control personnel of any manufactured cannabis product that is reprocessed and the determination by quality control personnel of whether the reprocessed manufactured cannabis product meets contaminant limits established in section 11-850-135;

(6) A written record of every product complaint that is related to production practices or production center standards:

(A) The person who performs the requirements of section 11-850-125 shall document, at the time of performance, that the requirement was performed; and

(B) The written record of the product complaint shall include the following:

(i) The name and description of the cannabis or manufactured cannabis product;

(ii) The batch number of the cannabis or manufactured cannabis product, if available;

(iii) The date the complaint was received and the name, address, or telephone number of the complainant, if available;

(iv) The nature of the complaint including, if known, how the cannabis or manufactured cannabis product was used;

(v) The reply to the complainant, if any; and

(vi) Findings of the investigation and follow-up action taken when an investigation is performed;

(7) A written record of every adverse event and report of an adverse event to the department as required by section 11-850-126; and

(8) A written recall plan as required by section 11-850-127.

(b) The records required by subsection (a) are subject to the requirements of section 11-850-41.

Notes

Haw. Code R. § 11-850-128

[Eff and comp 2/24/2022] (Auth: HRS §§ 321-9, 329D-8, 329D-9, 329D-27) (Imp: HRS §§ 329D-8, 329D-9, 329D-19) Comp 4/29/2022 Comp 11/17/2022 Comp 8/7/2023 Comp 4/5/2024 Comp 12/6/2024