Standard Practice for Requirements of a Quality Management System for Cannabis and Hemp Operations

Importancia y uso:

4.1 Having a concise set of QMS requirements allows users of this practice to understand "what" needs to be established, consistently practiced, monitored, maintained, and improved.

4.2 Guidance on "how" and "why" to implement the QMS elements are provided in the referenced guides and practices for each element.

4.3 These QMS requirements can be used as the basis for gap assessments, internal and external audits, training programs, certification programs, an implementation checklist, or a combination of these uses.

4.4 As the regulated cannabis industry moves forward, authorities having jurisdiction are adopting good practice protocols and quality management system requirements. QMS principles are a foundation for good manufacturing practices (GMP), good agricultural and collection practices (GACP), and good laboratory practices (GLP). This practice does not focus on a particular type of cannabis operation. It provides QMS requirements incorporating requirements specific to GMP, GACP, and GLP that can be applied to these operations.

4.5 Each type of operation may need to adapt a requirement to meet certain GACP, GMP, or GLP requirements by documenting the requirement and how it is adapted to meet the specific requirement.

4.6 When a QMS requirement is not applicable to an operation, the operation shall document the reason a requirement is not applicable. By doing this, each requirement is addressed and if the reason is justifiable the operation can be considered in full compliance with these requirements.

4.7 This practice provides an internationally recognized set of requirements that can be used by:

4.7.1 Operations that grow, harvest, process, test, package, or distribute adult-use and medicinal cannabis and hemp to voluntarily implement quality practices;

4.7.2 State and national regulatory agencies to inform good practice and quality-related regulations; and

4.7.3 Third-party training, consulting, and certification bodies to base their services on.

Subcomité:

D37.02

Referida por:

D8595-25

Volúmen:

15.10

Número ICS:

65.020.20 (Plant growing)

Palabras clave:

cannabis; CAPA; change management; consumer safety; continuous improvement; CQI; deviations; document control; GACP; GLP; GMP; hemp; internal audit; process control; QMS; qualifications; quality; quality management system; recall; SOPs; training;