PHA 052 Module 1: Quality Control System and Benefits
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Questions and Answers

What is the main focus of this lesson?

  • Identifying the Objectives of Quality Control System
  • Discovering benefits derived from a Quality Control System (correct)
  • Determining the Organizational Chart of Quality Control
  • Defining quality in everyday life

According to the preview/review, what do most people have regarding the meaning of quality?

  • A woolly and undefined explanation
  • A subjective view (correct)
  • Different meanings depending on the environment
  • A clear and definite definition

What is the productivity tip for the students?

  • To learn about the processes substances undergo before being placed in the market (correct)
  • To focus on everyday quality definitions
  • To define quality accurately
  • To understand different meanings of quality

In what publication year was the reference by D.C. Lee and M.L. Webb?

<p>2003 (A)</p> Signup and view all the answers

What is the actual lesson title?

<p>Introduction to Quality Control System and Benefits (C)</p> Signup and view all the answers

What materials are required for this module?

<p>Pen and SAS (B)</p> Signup and view all the answers

What is the traditional view of quality based on?

<p>Conformity with a pre-determined specification (B)</p> Signup and view all the answers

According to the text, what is the current accepted definition of quality within the context of the pharmaceutical industry?

<p>Fitness for purpose (D)</p> Signup and view all the answers

What does ISO 9000 quality standard define quality as?

<p>Fitness for purpose with customer satisfaction (C)</p> Signup and view all the answers

In the context of medicinal products, what does the text emphasize about assuring quality?

<p>Quality must be built in at each stage of the manufacturing process (A)</p> Signup and view all the answers

What is the philosophy of quality assurance according to the text?

<p>Maintaining batch to batch consistency by reducing variability of processes (C)</p> Signup and view all the answers

What activity is meant to get started on thinking about the topic, according to the text?

<p>Activity 1: What I Know Chart, Part 1 (B)</p> Signup and view all the answers

What does the text emphasize about the control of factors affecting medicinal product quality?

<p>All factors affecting product quality must be controlled (D)</p> Signup and view all the answers

What should written procedures and trained personnel ensure, according to the text?

<p>Consistently meeting predetermined specifications (A)</p> Signup and view all the answers

What should be maintained by reducing variability of all supporting processes, sub-processes, and procedures, according to the text?

<p>Batch to batch consistency (C)</p> Signup and view all the answers

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