Haw. Code R. § 11-37-56 - Standard operating procedures

(a) A hemp processor shall establish written processing and control standard operating procedures (SOPs; for example, formulations, processing procedures, in-process control methods, packaging procedures, procedures for operating equipment).

(b) Standard operating procedures shall include provisions to ensure that:

(1) The selection, weighing, and measuring of ingredients and the determination of finished yield are reviewed by a second individual;

(2) Major equipment, transfer lines, containers and tanks used for processing, holding, or filling are identified to indicate contents, batch identification, stage of processing, and control status;

(3) There are appropriate measures to prevent contamination with microorganisms, chemicals, filth, or other extraneous material;

(4) There are in-process controls to ensure product uniformity, integrity (for example, in-process batch weights), accurate fill of mixing containers, and adequacy of mixing;

(5) The theoretical yield for a production batch is compared with the actual yield;

(6) The storage and handling of packaging materials that are intended to come into direct contact with the product prevent mix-ups and microbiological or chemical contamination; and

(7) Finished product packages bear permanent, meaningful, unique batch numbers.

(c) Documentation of standard operating procedures shall be sufficient to prevent errors of interpretation and loss of information.

(d) Documentation of standard operating procedures shall be established and maintained subject to the requirements of section 11-37-55.

Notes

Haw. Code R. § 11-37-56

[Eff 8/9/21; comp 2/24/2022] (Auth: HRS § 328G-4) (Imp: HRS § 328G-4) Comp 4/29/2022 Comp 12/6/2024