1.
Presented by
P. INTHIYAZ BEGUM
Reg.No-18L81S0402
M. Pharmacy I year
Pharmaceutical Quality
Assurance
RIPER
Anantapur[AP], India

2.
o Introduction
o Objectives
o Principles of TQM
o Significance of TQM
o Elements
o Reasons to failure
o Benefits
o Importance
o Advantages
o Disadvantages
o Conclusion

3.
 Total quality management increases the customer
satisfaction by boosting the quality.
 It does by motivating the work force and improving
the way the company operates.
 In an increasing competitive market firms with a
continuous improvement culture and external focus
are more likely to survive and prosper.
 TQM is consider an important catalyst in this context.

4.
 TQM is an approach to improving the effectiveness
and flexibilities of business as a whole.
 It is essentially a way of organizing and involving the
whole organization every department, every activity
and every single person at every level.
 TQM ensures that the management adopts a strategic
overview of the quality and focuses on prevention
rather than inspection.

5.
 To provide high quality drug product to patients
 Process improvement
 Defects prevention
 Helping teams to make better decisions
 Continuous improvement to process systems, people
suppliers, partners, products and services

6.
 Management commitment
 Employee empowerment
 Fact based decision making
 Continuous improvement

7.
 The importance of TQM lies in the fact that in
encourages innovation, make the organization adaptable
to change , motivate people for better quality ,and
integrates the business arising out of the common
purpose and all those provide the organization with a
valuable and distinctive competitive edge.

8.
 Be customer focused
 Do it right the first time
 Constantly improve
 Quality is an attitude
 Telling staff what is going on
 Educate and train people
 Measure the work
 Top management must be involved
 Make it a good place work
 Introduce the team work
 Organize by process , not by function

9.
 TQM fails because :
 Top management sees no reasons for change
 Top management is not concerned for its staff
 Top management is not committed to the TQM
programmer
 The company loses interest in the programmer after
six months
 The work force and the management do not agree on
what needs to happen
 Urgent problem intervene
 TQM is imposed on the workforce ,which does not
in wardly accept it

10.
 Improvement of quality
 Employee participation
 Team work
 Working relationship
 Customer satisfaction
 Employee satisfaction
 Productivity
 Communication
 Profitability
 Market share

11.
 Handling:
 Containers should be opened carefully and
subsequently resealed in an approved manner.
 Highly sensitive materials such as penicillin's and
cephalosporin's should be handle in separate
production area.
 Highly active should be manufacture in a dedicate area
and using delectated reagent.
 Pure and API should be handle in an environmental
giving the adequate protection against contamination.

12.
 Secure storage facilities should be designated for use
to prevent damage of materials.
 Should be kept clean and tidy and subject to the
appropriate pest control measurement.
 Environmental conditions should be recorded.
 Storage conditions for API should be based upon
stability studies taking into account time.
 Temperature,
 Humidity,
 Light etc……

13.
 Labelling and packaging processes should be defined
and controlled to ensure that correct packaging
materials are used correctly and other specified
requirements are met.
 Printed labels should be securely to avoid mix ups
arising store.
 Marking and labeling should be legible and durable,
provide sufficient information for accurate
identification and indication require storage
conditions retest.

14.
 The location ,design, and construction of buildings
should be suitable for the type and stage of
manufacture involved protecting the product from
contamination and protecting operators and the
environment from the product.
 Equipment surfaces in contact with materials used in
API manufacturing should be non reactive.

15.
 Personnel suffering from an infectious disease or
having open lesions on the exposed surface of the
body should avoid activities could compromise the
quality of API.
 LABELLING
 Each container should be identified by an appropriate
label ,showing at least the product identification and
assigned batch code.
 Containers for external distribution may require
additional labels.

16.
 Improves reputation :faults and problems are spotted
and sorted quicker.
 Higher employee morale : workers motivated by extra
responsibility , team work and involvement in decision
of total quality management.
 Lower cost.
 Decrease waste as fewer defective products and no
need for separate.

17.
 Initial introduction cost .
 Benefits may not be seen for several years .
 Workers may be resistant to change.
 It can be lead to too much attention.
 Extremely demanding of management and staff.
 It is not a quick fix. TQM takes to implement .

18.
 Total quality management encourages participation
amongst ,employees ,managers ,and organizations
whole.
 The responsibilities either its professional, social ,
legal, one that the rest with the pharmaceutical
manufacturing for the assurance of quality.
 Control should be practiced rigorously.
 The firms which want to implement TQM effectively
must have a patience .
 If you change from bad process to good process ,you
are sure to get good results and improvement .