Haw. Code R. § 11-850-121 - Standard operating procedures
(a) A medical
cannabis dispensary shall establish written processing and control standard
operating procedures for the production of cannabis and manufactured cannabis
products (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
11-850-41.
Notes
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