PHA 052 Module 1: Quality Control System and Benefits

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15 Questions

What is the main focus of this lesson?

Discovering benefits derived from a Quality Control System

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

A subjective view

What is the productivity tip for the students?

To learn about the processes substances undergo before being placed in the market

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

2003

What is the actual lesson title?

Introduction to Quality Control System and Benefits

What materials are required for this module?

Pen and SAS

What is the traditional view of quality based on?

Conformity with a pre-determined specification

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

Fitness for purpose

What does ISO 9000 quality standard define quality as?

Fitness for purpose with customer satisfaction

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

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

Maintaining batch to batch consistency by reducing variability of processes

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

Activity 1: What I Know Chart, Part 1

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

All factors affecting product quality must be controlled

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

Consistently meeting predetermined specifications

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

Batch to batch consistency

Test your knowledge about the objectives and benefits of quality control system with this activity sheet for PHA 052 Module 1. Fill in the blanks and answer questions to demonstrate your understanding of the lesson.

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