Hazard Analysis for Cannabis Operations

hazard analysis for cannabis operations

The cannabis industry is under much scrutiny from a regulatory perspective. SOPs and best practices from various established industries have been adopted and applied to the cannabis industry. One of which is Hazard Analysis within the vertical of cannabis manufacturing.

Hazard Analysis for Cannabis Operations

The California Department of Public Health (CDPH) is the regulatory body that oversees cannabis manufacturing. The current re-adopted emergency regulations can be accessed here.

Regarding Hazard Analysis, CDPH states,

§40256. Hazard Analysis. The licensee shall conduct and prepare a written hazard analysis to identify or and evaluate known or reasonably foreseeable hazards to the consumer for each type of cannabis product produced at their facility the manufacturing premises in order to determine whether there exist any hazards requiring a preventive control. The hazard analysis shall include:

(a) The identification of potential hazards, including:

(1) Biological hazards, including microbiological hazards;
(2) Chemical hazards, including radiological hazards, pesticide(s) contamination, solvent or other residue, natural toxins, decomposition, or food allergens; and
(3) Physical hazards, such as stone, glass, metal fragments, hair or insects.

(b) The evaluation of the hazards identified in order to assess the severity of any illness or injury that may occur as a result of a given hazard, and the probability that the hazard will occur in the absence of preventive controls.

(c)The hazard evaluation shall consider the effect of the following on the safety of the finished cannabis product for the intended consumer:

(1) The sanitation conditions of the manufacturing premises;
(2) The product formulation;
(3) The design, function and condition of the manufacturing facility premises and its equipment;
(4) The raw material, ingredients and other components used in a given cannabis product;
(5) Product transportation and transfer practices;
(6) The manufacturing and processing procedures;
(7) The packaging and labeling activities;
(8) The storage of components and/or the finished cannabis product;
(9) The intended or reasonably foreseeable use of the finished cannabis product;
(10) Any other relevant factors.

It is important to note that upon completion of the Hazard Analysis within the manufacturing facility the licensee shall identify and implement written preventive controls to provide assurance that any hazards requiring a preventative control will be significantly minimized or prevented such that the manufactured cannabis product is not adulterated or misbranded.

Additionally, the regulations require that training programs must include training on hazard analysis and control procedures, as appropriate (§40280. Training Program (c)).

Hazard Analysis with Gaiaca

Trained Gaiaca technicians can conduct a facility inspection to identify potential hazards including, but not limited to, biological, chemical, and physical. Hazards are evaluated and reported to the client, with recommendations for remediation and preventative control. This service meets the regulatory requirements set forth by the California Department of Public Health.

To learn more about Hazard Analysis services, please reach out to us here to schedule a phone consultation.