Initiate Quality Risk Management (QRM) Process

What is QRM in pharma?

QRM is the overall and continuing process of appropriately managing risks to product quality throughout the product's life cycle in order to optimize its benefit-risk balance. It is a systematic process for the assessment, control, communication, and review of risks to the quality of the medicinal product.

QRM activities should be performed using systematic processes designed to coordinate, facilitate and improve science-based decision-making with respect to risk. The possible steps to be taken in initiating and planning a QRM process might include the following :

1. Define the problem and/or risk question, including pertinent assumptions identifying the potential for risk;
2. Assemble background information and/or data on the potential hazard, harm or human health impact relevant to the risk assessment;
3. Identify a leader and the necessary resources;
4. Specify a timeline, the deliverables, and an appropriate level of decision-making for the risk management process.

Internal SOPs should define steps, stakeholders, roles and responsibilities.

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How to initiate a QRM process?

• Traditionally Hazard analysis and critical control point (HACCP) was adopted to do the risk assessment, Recently quality risk assessment is followed that is more relevant to the pharmaceutical industries. The guideline on Quality risk assessment to protect patients in terms of quality safety and efficacy of medicines.
• In QRM systematic science-based decision-making with respect to risk shall be considered. To initiate the QRM the problem shall be identified including possible risk. Detailed information shall be gathered which can lead to potential hazards or have a harmful effect on human health and is relevant for the risk assessment
• The problem can only be identified if there is adequate knowledge related to the product and processes. Therefore personnel with appropriate product-specific knowledge and expertise are required to accomplish the QRM activities. This could best be done by assembling a multidisciplinary team and a team leader who can direct the team in right direction.

• As QRM can be adopted proactively or retrospectively, therefore in retrospective application those parts or QRM could be incorporated which are not analyzed previously.
• As industries that already have incorporated Hazard analysis and critical control points have most of the information available with them, the remaining information can be gathered to achieve QRM.

Comparison of QRM vs HACCP

• In both QRM and HACCP, the multidisciplinary team (with a team leader) is to be formed who have product knowledge and good expertise and are capable to conduct risk assessment.
• The second preliminary step for HACCP is to describe the product. Though in QRM it is not directly mentioned to describe the product but specified to assemble background information which by default covers the product information..
• The third preliminary step of HACCP is to describe the intended use of the product. The intended use of the product is required to assess the potential effect of the hazard on the given group of people. In QRM it is specified to collect the data on the potential hazard or impact on human health.
• The fourth preliminary step in HACCP is to construct a flow diagram. In HACCP it is mentioned that the flow diagram must be simple with clear indication of inputs and outputs. Whereas in QRM there is more focus on detailed flow diagrams, a block diagram is preferred with sufficient description. It shall cover all operations and controls in the process under evaluation.
• The fifth preliminary step in HACCP is to verify the flow diagram, In QRM it is not required.

The QRM shall be reviewed at least once in a year during self-inspection.

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