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(solved) Managing Quality And Risk

(solved) Managing Quality And Risk

Managing Quality And Risk


What exactly is Quality Risk Management (QRM)?

Quality risk management is a risk-based approach to quality management that is systematic. The process consists of assessing, controlling, communicating, and reviewing quality risks. It is especially important in the pharmaceutical industry, where product quality can significantly impact consumer health and safety.

Principles of Quality Risk Management

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) defines quality risk management as having two primary principles:

Quality risk assessment should be based on scientific knowledge, such as data and research, and should ultimately work to protect consumers.

The greater the risk, the more robust the QRM process should be. The level of effort, formality, and documentation should be proportionate to the level of risk.


These principles are illustrated in the following examples from the European Commission’s Good Distribution Practice (GDP) Guidelines for Medicinal Products:

Temperature and environmental control: Temperature mapping should be repeated based on risk assessment results.

Equipment calibration should occur at predetermined intervals based on a risk and reliability assessment.

Qualification and Validation: A documented risk assessment approach must be used to determine the scope and extent of key equipment qualification or key process validation.

Principles of Operation: All available means must be used to reduce the risk of falsified medicinal products entering the supply chain.

Medicinal Products Returned: Returned products must be handled by a documented, risk-based process.

Transportation: Risk assessment of delivery routes should be used to determine where temperature controls are required.

What is the Importance of Quality Risk Management?

Quality risk management is important because it allows for more informed and better decisions. Decision-making with QRM has the following characteristics:

Decisions are data-driven rather than subjective.

The potential impact on consumers’ lives is prioritized.

Another advantage is that companies can use risk level as a basis for prioritization, resulting in more efficient resource use. Furthermore, it develops a culture of trust and transparency among businesses and regulatory authorities.

GDP, an internationally recognized set of standards for ensuring the quality of medicines throughout the supply chain, also requires quality risk management. While GDP is primarily enforced in Europe, it is increasingly used in the United States and other countries.

Managing Quality And Risk

Managing Quality And Risk


Managing Quality And Risk

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