Haw. Code R. § 11-850-123 - Quality control review and disposition decisions
(a) A dispensary shall establish and follow
written standard operating procedures and assign specific staff persons as
quality control personnel to fulfill the requirements of this
section.
(b) Quality control
personnel shall conduct a review and make a disposition decision if:
(1) A contaminant limit or water activity
limit established in section
11-850-135 is exceeded;
(2) Production of a batch deviates from
established standard operating procedures, including when any step is not
completed;
(3) There is any
unanticipated occurrence during production operations that contaminates or may
lead to contamination of cannabis, a manufactured cannabis product, component,
or packaging, or could lead to the use of an incorrect label;
(4) Calibration of an instrument or control
suggests a problem that may have resulted in a failure to ensure the quality of
a batch of cannabis or manufactured cannabis product; or
(5) Cannabis or a manufactured cannabis
product is returned.
(c)
The quality control review shall include examination of the following, as
applicable:
(1) Batch production
records;
(2) Certificates of
analysis or other testing records for ingredients;
(3) Laboratory analysis records for finished
product;
(4) Label and packaging
integrity;
(5) Use by date;
and
(6) Any other examinations
necessary to determine whether quality standards are met.
(d) When there is a deviation or
unanticipated occurrence during the production and in-process control system
that results in or could lead to contamination of cannabis, a manufactured
cannabis product, a component, or packaging, or could lead to the use of an
incorrect label, quality control personnel shall reject the cannabis,
manufactured cannabis product, component, packaging, or label unless quality
control personnel approve a treatment, an in-process adjustment, or
reprocessing to correct the applicable deviation or occurrence.
(e) The person who conducts the review and
makes the disposition decision shall, at the time of performance, document that
review and disposition decision in accordance with section
11-850-128.
Notes
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