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PHA 052 Module 1: Quality Control System and Benefits

15 Questions

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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?

2003 Signup and view all the answers

What is the actual lesson title?

Introduction to Quality Control System and Benefits Signup and view all the answers

What materials are required for this module?

Pen and SAS Signup and view all the answers

What is the traditional view of quality based on?

Conformity with a pre-determined specification 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?

Fitness for purpose Signup and view all the answers

What does ISO 9000 quality standard define quality as?

Fitness for purpose with customer satisfaction Signup and view all the answers

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

Quality must be built in at each stage of the manufacturing process Signup and view all the answers

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

Maintaining batch to batch consistency by reducing variability of processes Signup and view all the answers

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

Activity 1: What I Know Chart, Part 1 Signup and view all the answers

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

All factors affecting product quality must be controlled Signup and view all the answers

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

Consistently meeting predetermined specifications 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?

Batch to batch consistency Signup and view all the answers