Haw. Code R. § 11-850-122 - Batch production and distribution records

(a) Production records shall document, for each batch of cannabis or manufactured cannabis product:

(1) Review of ingredient records to determine if ingredients are adequately controlled;

(2) Ingredients (name, code, batch number, quantity, etc.) added to the batch;

(3) Production steps (for example, processing, handling, transferring, holding, and filling);

(4) In-process sampling, controlling, and adjusting steps;

(5) Compliance with or deviations from standard operating procedures;

(6) Detailed description of any deviations from standard procedures/ justifications for the deviations, and corrective measures taken;

(7) Any quality control review and disposition decision and follow-up required by section 11-850-123;

(8) Any remediation carried out under section 11-850-129; and

(9) Batch number.

(b) Distribution records shall identify, for each batch of cannabis or manufactured cannabis product:

(1) The product;

(2) The batch number;

(3) The retail dispensing location; and

(4) The date of distribution.

(c) Batch production and distribution records shall be adequate to conduct an effective recall.

(d) Batch production and distribution records shall be established and maintained subject to the requirements of section 11-850-41.

Notes

Haw. Code R. § 11-850-122

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