Haw. Code R. § 11-37-70

Current through November, 2024
Section 11-37-70 - Batch production and distribution records
(a) Production records shall document, for each batch of hemp 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 SOPs;
(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 11-37-71; and
(8) Batch number.
(b) Distribution records shall identify, for each batch of hemp product:
(1) The product;
(2) The batch number;
(3) The consignee; 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 11-37-55.

Haw. Code R. § 11-37-70

[Eff 8/9/21; comp 2/24/2022] (Auth: HRS §§ 328G-4, 328G-5) (Imp: HRS SS328G-4, 328G-5)
Comp 4/29/2022