California Code of Regulations › Title 4 - Business Regulations › Division 19 - Department of Cannabis Control › Chapter 8 - Manufacturers › Article 4 - Good Manufacturing Practices › Section 17207 - Manufacturing Practices Definitions

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
In addition to the definitions in section
					 26001 of the Act and section
					 15000 of this division, the
					 following definitions shall govern the construction of this chapter:
(a) "Allergen cross-contact" means the
				  unintentional incorporation of a food allergen into a cannabis
				  product.
(b) "Component" means any
				  substance or item intended for use in the manufacture of a cannabis product,
				  including those substances or items that are not intended to appear in the
				  finished cannabis product. "Component" includes cannabis, cannabis products
				  used as ingredients, raw materials, other ingredients, and processing
				  aids.
(c) "Contact surface" means
				  any surface that contacts cannabis products and cannabis product components and
				  those surfaces from which drainage, or other transfer, onto the cannabis
				  product or cannabis product components, occurs during the normal course of
				  operations. Examples of contact surfaces include containers, utensils, tables,
				  and equipment.
(d) "Easily
				  cleanable" means a characteristic of a surface that allows effective removal of
				  soil, food residue, or other organic or inorganic materials by normal cleaning
				  methods.
(e) "Environmental
				  pathogen" means a pathogen capable of surviving and persisting within the
				  manufacturing environment such that cannabis products may be contaminated and
				  may result in illness if consumed or used without treatment to significantly
				  minimize the environmental pathogen. Examples of environmental pathogens
				  include
Listeria monocytogenes
and
Salmonella
				  spp.
but do not include the spores of pathogenic spore-forming
				  bacteria.
(f) "Hazard" means any
				  biological, chemical, radiological, or physical agent that has the potential to
				  cause illness or injury.
(g)
				  "Holding" means storage of cannabis or cannabis products and includes
				  activities performed incidental to storage of a cannabis product and activities
				  performed as a practical necessity for the distribution of that cannabis
				  product.
(h) "Microorganisms" means
				  yeasts, molds, bacteria, viruses, protozoa, and microscopic parasites and
				  includes species that are pathogens. The term "undesirable microorganisms"
				  includes those microorganisms that are pathogens, that subject a cannabis
				  product to decomposition, that indicate that a cannabis product is contaminated
				  with filth, or that otherwise may cause a cannabis product to be
				  adulterated.
(i) "Monitor" means to
				  conduct a planned sequence of observations or measurements to assess whether
				  preventive measures are operating as intended.
(j) "Pathogen" means a microorganism that can
				  cause illness or injury.
(k)
				  "Potable" means water that meets the requirements of Health and Safety Code
				  section
				  113869.
(l) "Preventive measures" means those
				  risk-based, reasonably appropriate procedures, practices, and processes that a
				  person knowledgeable about the safe manufacturing, processing, packing, or
				  holding of food would employ to significantly minimize or prevent the hazards
				  identified pursuant to a product quality plan as specified in section
				  17214.
(m) "Processing aid" means any substance that
				  is added to a cannabis product during manufacture but is removed in some manner
				  from the cannabis product before it is packaged in its finished form. This
				  includes substances that are converted into constituents normally present in
				  the product, and do not significantly increase the amount of the constituent
				  naturally found in the product. This also includes substances that are added to
				  a product for their technical or functional effect in the processing but are
				  present in the finished product at insignificant levels and do not have any
				  technical or functional effect in that product.
(n) "Qualified individual" means a person who
				  has the education, training, or experience (or a combination thereof) necessary
				  to manufacture quality cannabis products as appropriate to the individual's
				  assigned duties. A qualified individual may be, but is not required to be, an
				  employee of the licensed manufacturer.
(o) "Quality control" means a planned and
				  systematic operation or procedure for ensuring the quality of a cannabis
				  product.
(p) "Quality control
				  operation" means a planned and systematic procedure for taking all actions
				  necessary to prevent cannabis product(s) from being adulterated or
				  misbranded.
(q) "Quality control
				  personnel" means any person, persons, or group designated by the licensed
				  manufacturer to be responsible for quality control operations.
(r) "Raw material" means any unprocessed
				  material in its raw or natural state that is intended to become part of the
				  components of a cannabis product.
(s) "Sanitize" means to treat cleaned
				  surfaces by a process that is effective in destroying vegetative cells of
				  pathogens and substantially reducing numbers of other undesirable
				  microorganisms, but without adversely affecting the product or its safety for
				  the consumer.
(t) "Smooth" means
				  any of the following:
(1) A contact surface
				  that is free of pits, pinholes, cracks, crevices, inclusions, rough edges, and
				  other surface imperfections detectable by visual or tactile
				  inspection.
(2) A floor, wall, or
				  ceiling having an even or level surface with no roughness or projections that
				  render it difficult to clean.