Pharmaceutical Quality Management Quiz

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.

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.