Total Quality Management (TQM) in Pharma Industry

Introduction:
The pharma industry develops, produces, and markets authorized medicine to be used as
medications and it's a vital sector for the health care field that is regulated heavily because;
any error in product style or manufacture will impact on the health of the patients . The low
qualities of drugs don't seem to be solely a pathologic state however conjointly losing money
for each government and private customers. So, the upkeep of the standard with continuous
development and Improvement is extremely vital for pharma industry. From this concept Total
Quality Management (TQM) was established

The aim of TQM is prevention of defects instead of detection of defects. Therefore TQM is
extremely vital for pharma industry to manufacture and turn out the higher product and make
sure the most safety of health care sector and conjointly shield losing of money for both
government and private customers.

Definition:
 Total Quality Management (TQM) has been outlined as associate integrated structure
effort designed to enhance quality at each level. [1]
 The process to supply an ideal product by a series of measures requiring associate
organized effort by the complete company to forestall or eliminate errors at each stage in
production is termed Total Quality Management. [2]
 According to world organization for standards outlined TQM as, “TQM may be a
management approach for a company, targeted on quality, supported the participation of
all its members and aiming at long success through client satisfaction and advantages to
all or any members of the organization and to the society
Aspects of TQM

There are three aspects of TQM :

 Counting: Tools, techniques, and coaching in their use for analyzing,

Understanding and determination quality issues.
 Customers: Quality for the client as a thrust and central Concern.
 Culture: Shared values and beliefs, expressed by leaders, that outline and
support quality.

Principles of TQM

1. Produce quality work the primary time and each time.

2. Focus on the client.
3. Have a strategic approach to improvement. Improve endlessly.
4. Encourage mutual respect, cooperation and teamwork.

[3]
The key components of the TQM :

1- Focus on the customer.

2- Employee involvement.
3- Continuous improvement.

1- Focus on the customer.

 It is vital to determine the organization’s customers.
 External customers consume the organization’s product or service.
 Internal customers are workers who receive the output of alternative workers.

2- Employee involvement
 Since the quality is taken into account the task of all workers, employees ought to be
involved in quality initiatives.
 Front line employees are probably to own the highest contact with external customers
and so will create the most valuable contribution to quality.
 Therefore, employees should have the authority to innovate and improve quality.
 3- Continuous improvement.
 The quest for quality may be an unending method within which individuals are
endlessly operating to enhance the performance, speed and range of options of the
products or service.
 Continuous improvement means little, progressive improvement that happens on an
everyday basis can eventually add up to immense improvement in quality.
 TQM is that the management process used to create continuous enhancements to all
or any functions.
 TQM represents associate in progress, continuous commitment to improvement.
 The foundation of total quality may be a management philosophy that supports meeting
client needs through continuous improvement.

Characteristics of TQM [4] :

1- Committed management
2- Adopting and communicating Total Quality Management
3- Closer client relations
4- Closer supplier relations
5- Bench-marking
6- Increased coaching
7- Open organization
8- Employee direction, empowerment.
9- Flexible production.
10- Process enhancements, improvements
11- Process measuring.

BENEFITS OF TOTAL QUALITY MANAGEMENT

1- Financial advantages include lower costs, higher returns on sales and investment, and
Therefore the ability to charge higher instead of competitive prices.
2- Improved access to world markets, higher client retention levels, less Time needed to
Develop new innovations, and a name as a top quality firm.
 3- Total quality management (TQM) is one such approach that seeks to enhance quality
and Performance which can meet or exceed client expectations.

Advantage of TQM:

1. Improves reputation- faults and problems are noticed and sorted faster.
2. Higher employee morale- workers motivated by further responsibility,
team work and involvement indecisions of TQM
3. Lower cost – decrease waste as fewer defective products and no want for
separate.
4. Quality control inspector
5. Profitability.
6. Market share.

Disadvantage:

1. Initial introduction cost.

2. Benefits may not be seen for many years.
3. Workers may be resistant to change.

 Importance of TQM in pharma industry [5] :

 Handling:
 Containers ought to be opened carefully and subsequently resealed in an
approved manner.
 Highly sensitising material such as antibiotics and oncology products should be
handled in separate production areas.
 Highly active or toxic APIs (e.g. certain steroids, cytostatic substances) should be
manufactured in a dedicated area and using dedicated equipment.
 Pure and final API should be handled in an environment giving adequate protection
against contamination.
 Storage
 Secure storage facilities should be designated for use to prevent damage or
deterioration of materials.
 These should be kept clean and tidy and subject to appropriate pest control
measures.
 Environmental conditions ought to be recorded.
 The condition of stored material should be assessed at applicable intervals.
 Storage conditions for API should be based upon stability studies taking
under consideration time, temperature, and humidity, light.

 Packaging:
 Labelling and packaging processes should be outlined and c o n t r o l l e d to
confirm t h a t correct packaging materials are used properly and other
specified requirements are met.
 Printed labels should be securely stored to avoid mix-ups arising.
 Marking and labelling should be legible and durable, give adequate information,
for accurate identification and indicate, if applicable, required storage
conditions, retest and/or expiry date.

 Facilities and equipment:

 The location, design, and construction of buildings should be appropriate for the
type and stage of manufacture concerned, protecting the product from
contamination (including cross-contamination) and protecting operators and the
environment from the product.
 Equipment surfaces in contact with materials used in API manufacture should
be non-reactive.
  Sterile area
 Personnel suffering from an infectious disease or having open lesions on the
exposed surface of the body should avoid activities that might compromise the
quality of API.
 Smoking, eating, drinking, chewing and storage of food should be restricted to
designated areas separated from production or control areas.

 Labelling
 Each container should be identified by an appropriate label, showing at
least the product identification and the assigned batch code, or any
other easily understandable combination of both.
 Containers for external distribution may require additional labels.

 Computerized systems
 Computer systems should be designed and operated to prevent
unauthorized entries or changes to the programme.
 In the case of manual entry of quality critical data there should be a
second independent check to verify accuracy of the initial entry.
 A back-up system should be provided of all quality critical data.

Conclusion:

 The professional, social and legal responsibilities that rest with the pharmaceutical
manufacturers for the assurance of product quality are tremendous.
 It is only through well organized, adequately staffed accurately performed process and
dosage form control before, during and after production that adequate quality
assurance of the product can be achieved.
 It should be realized that no amount of dosage form testing and control can maintain
and assure product quality unless good manufacturing practices (GMP) are
implemented systematically and process control is practiced rigorously. Product
 quality must be building into and not merely tested in the product. The pharmaceutical
manufacturer assumes the major responsibility for the quality of his products.
 TQM encourages participation amongst employees, managers and organization
as whole.

 Using Quality management reduces rework nearly to zero in an achievable

goal .The responsibilities either its professional, social, legal one that rest with the
pharmaceutical manufacturer for the assurance of quality of product are
tremendous and it can only be achieved by well organized.
 Work culture and complete engagement of the employees at the work place. It
should be realized that national & international regulations must implemented
systematically and process.
 Control should be practiced rigorously.
 Thus quality is critically important ingredient to organizational success today which
can be achieved by TQM, an organizational approach that focusses on quality as
an over achieving goals, aimed at aimed at the prevention of defects rather than
detection of defects..
Reference:
1. Sudhanshu Bala Singh & Dr. R. S. Dhalla, “Effect of Total Quality Management
on Performance of Indian Pharmaceutical Industries” Proceedings of the 2010
International Conference on Industrial Engineering and Operations
Management. Dhaka, Bangladesh, January 9 – 10, 2010.
2. Bhaskar Mazumder, Sanjib Bhattacharyaand & Abhishek Yadav, “Total Quality
Management in Pharmaceuticals: A Review”, International Journal of
PharmTech Research
3. Bhaskar Mazumder, Sanjib Bhattacharyaand & Abhishek Yadav, “Total Quality
Management in Pharmaceuticals: A Review”, International Journal of
PharmTech Research. Page: 367
4. Master Thesis, Blekinge Institute of Technology 2006, 1.1 Definitions of Total
Quality Management.
5. Text book of Total Quality Management by L.Suganthi and Anand A.Samuel,2nd
edition,2005,page no.49-61.

6. Total Quality Management by R.S Nagarajan, A.A.Arivalangar, new age

international publishers,1st edition,2009,page no.21.