Pharmaceutical Quality Management Quiz

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Questions and Answers

What is quality?

The degree to which a set of inherent properties of a product, system or process fulfills requirements.

What is a Pharmaceutical Quality System?

A management system to direct and control a pharmaceutical company with regard to quality.

What does a Quality System encompass?

The sum of all aspects of a system that implements quality policy and ensures that quality objectives are met.

Define Quality Risk Management.

A systematic process for the assessment, control, communication, and review of risks to the quality of the drug product across the product lifecycle. Signup and view all the answers

What is Change Management?

A systematic approach to proposing, evaluating, approving, implementing, and reviewing changes. Signup and view all the answers

What is Product Realisation?

Achievement of a product with the quality attributes appropriate to meet the needs of patients, health care professionals, and regulatory authorities. Signup and view all the answers

Define Risk.

The combination of the probability of occurrence of harm and the severity of that harm. Signup and view all the answers

What is Risk Acceptance?

The decision to accept risk. Signup and view all the answers

Describe Risk Analysis.

The estimation of the risk associated with the identified hazards. Signup and view all the answers

What is Risk Assessment?

A systematic process of organizing information to support a risk decision within a risk management process. Signup and view all the answers

Define Risk Communication.

The sharing of information about risk and risk management between the decision maker and other stakeholders. Signup and view all the answers

What does Risk Control refer to?

Actions implementing risk management decisions. Signup and view all the answers

What is Risk Evaluation?

The comparison of the estimated risk to given risk criteria using a quantitative or qualitative scale. Signup and view all the answers

What is Risk Identification?

The systematic use of information to identify potential sources of harm refers to the risk question or problem description. Signup and view all the answers

Define Risk Management.

The systematic application of quality management policies, procedures, and practices to the tasks of assessing, controlling, communicating, and reviewing risk. Signup and view all the answers

What is Risk Reduction?

Actions taken to lessen the probability of occurrence of harm and the severity of that harm. Signup and view all the answers

Study Notes

Quality Concepts

Quality refers to how well a product, system, or process meets specified requirements.

Pharmaceutical Quality System

A management framework that guides pharmaceutical organizations in maintaining quality standards.

Quality System

Encompasses all components crucial for executing the quality policy and achieving set quality objectives.

Quality Risk Management

A structured approach for assessing, controlling, communicating, and reviewing risks associated with drug quality throughout its lifecycle.

Change Management

A methodical process for proposing, evaluating, approving, implementing, and reviewing changes within systems and processes.

Product Realisation

Involves ensuring that a product meets required quality attributes to satisfy patients, healthcare professionals, regulatory bodies, and internal customers.

Risk

Defined as the likelihood of occurrence of harm combined with the potential severity of that harm.

Risk Acceptance

The choice to acknowledge and take on potential risks.

Risk Analysis

Involves estimating the risks linked to identified hazards.

Risk Assessment

A systematic method for organizing relevant information to inform risk-based decisions; includes hazard identification, risk analysis, and risk evaluation.

Risk Communication

Process of exchanging information regarding risks and risk management strategies between decision-makers and stakeholders.

Risk Control

Implementation of actions based on risk management decisions.

Risk Evaluation

Comparing estimated risks against predefined criteria using quantitative or qualitative metrics to gauge their significance.

Risk Identification

Systematic process aimed at pinpointing potential hazards that may cause harm.

Risk Management

The organized application of quality management practices aimed at assessing and mitigating risks.

Risk Reduction

Actions taken to decrease both the likelihood of harm occurring and the potential severity of that harm.

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Description

Test your understanding of pharmaceutical quality systems, risk management, and quality assurance processes. This quiz covers key concepts that ensure compliance with quality requirements in the industry. Enhance your knowledge of how these systems operate effectively within pharmaceutical companies.