10. Quality and Related Concepts

11. Total Quality Management and Other Quality

Management Systems

12. ISO Series, NABL and GLP

Summary

4

Quality Management Systems

150 Industrial Pharmacy II

QUALITY

If we go with the dictionary meaning of quality, then quality means “standard of

something when compared with one that already exists, or degree of excellence of

something.”

Quality is something that motivates organisations not only to achieve the minimum

excellence mark but also to improve it continuously. Quality of any product depends

upon the stakeholders, i.e. their demands and expectations from the products. Here,

stakeholder means everyone who has an interest in the product directly or indirectly.

Customers comprise a large group of stakeholders. Other stakeholders are investors,

employees, suppliers, etc.

Quality of any product can be assured by three ways:

i. By setting guidelines which are compulsory for an organisation to follow.

ii. By setting up an effective quality control system in the organisation that will

maintain the ensured quality.

iii. By developing a culture in the organisation of improving the quality.

This unit deals with the same concept of quality and different quality management

systems developed for ensuring quality. Different ISO series have also been discussed

in this unit.

10.1 CONCEPT OF QUALITY

The quality in the pharmaceutical industry is a very important topic. The government

regulatory agencies, drug manufacturers, customers and other stakeholders all joined

together to give or to have a quality product. Every agency or stakeholders define

quality differently. Everyone has its meaning of quality.

According to ASQC (American Society for Quality Control) quality can be defined

as the totality of features and characteristics of a product that bears on its ability to

satisfy the stated or implied needs.

ISO, an international body for formulating standards, has defined quality as: “Degree

to which a set of inherent characteristics fulfils requirements”.

According to ICH quality is the degree to which a set of inherent properties of a

product, system or process fulfils requirements.

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Quality and Related Concepts

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Quality and Related Concepts 151

There are many ways to define quality like:

a. “It delivers the properties described on the label and is not contaminated”

b. “Fitness for intended use”

c. “Freedom from defects”

d. “Meeting or exceeding customer expectations”

We can summarise these definitions of quality as:

i. User-based: “In the eyes of beholder/what user expects.”

ii. Manufacturing-based: “Right at the first time”

iii. Product-based: “Precise as per specifications”

Dimensions of Quality

There are eight dimensions which decide either the product is a quality product or

not. These are as follows (Fig. 10.1):

i. Performance

ii. Features

iii. Reliability

iv. Conformance

v. Durability

vi. Serviceability