Standard Guide for Establishing a Quality Management System (QMS) for Consumer Use of Cannabis/Hemp Products

Importancia y uso:

5.1 Effective decision-making in a quality systems-controlled environment comes from an informed understanding of quality issues and associated risks. As such, management should monitor and review the performance of the QMS at pre-planned and regular intervals to ensure the system’s effectiveness and identify opportunities for improvement of the QMS itself. Management should also provide oversight of the QMS by an independent quality practitioner(s) to assure its effectiveness.

5.2 Moreover, risk-based decision-making encompasses all elements of the QMS and should be at the forefront of each decision. Consumer safety is the top priority, regardless of other considerations.

5.3 Aspects of risk should be considered relative to intended (or unintended) uses of a product to ensure consumer safety. Management should assign priorities and adequate resources to activities or actions based on assessing the risk, including the probability of harm and the potential severity of that harm. It is essential to engage appropriate parties in evaluating the risk. Such parties may include:

5.3.1 Consumers;

5.3.2 Manufacturing personnel;

5.3.3 Marketing personnel; and

5.3.4 Other stakeholders, as needed.

5.4 Implementation of risk management includes assessing the risks, implementing risk management controls commensurate with the level of risk, and evaluating the risk management efforts’ results. Risk management assessment is an iterative process and continues when additional information emerges that changes the potential risk’s nature.

5.5 Risk management works in conjunction with process understanding to manage and control change and helps drive continuous improvement.

Subcomité:

D37.02

Referida por:

D8557-24, D8398-22, D8556-24, D8477-22

Volúmen:

15.10

Número ICS:

11.120.99 (Other standards related to pharmaceutics)

Palabras clave:

cannabis; CAPA; change management; continuous improvement; deviations; hemp; IQ/OQ/PQ; marijuana, consumer safety; qualifications; quality control; quality management system, document control; process control; recall; removal; SOPs maintenance; training; validation; verification;