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Total Quality Management of Pharmaceuticals: Recent Approaches and

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TOTAL QUALITY MANAGEMENT OF PHARMACEUTICALS: RECENT APPROACHES AND ADVANCEMENTS

S. Bhandari and *A.
*A. Baldi
Department of Quality Assurance, I.S.F. College of Pharmacy, Moga, Punjab – 142001

Received on 11/11/04/2014
04/2014 Revised
evised on 22/
22/04/2014 Accepted on 01/
01/05/2014
/2014
ABSTRACT:
ABSTRACT:
Quality of pharmaceuticals has always been a prime area of concern for regulatory agencies across the globe in order to
facilitate production of medicines without batch to batch variations and hence maintaining the same therapeutic
effectiveness with the advent of total quality management a new vista has opened for assured quality of
pharmaceuticals. Total quality management being a multidimensional approach essentially requires adherence to
quality practices in all areas of pharmaceutical production. Application of various approaches and practices viz. quality
by design, quality risk management, six sigma approach along with following regulatory guidelines in all facets may lead
to practical realization of this concept. This article presents a brief review of existing industrial practices of total quality
management with special emphasis on recent advancements in online production monitoring, sophisticated analytical
tools and anti-counterfeiting technologies.
Keywords: Counterfeit drugs, Good manufacturing practices, Lean manufacturing, Quality, Quality by design, Quality risk
management.
*Corresponding Author:

Dr. Ashish Baldi

Principal and Professor,
I.S.F. College of Pharmacy,
G.T. Road, N.H. 95,
Moga (Punjab) 142 001
Email: [email protected]
Telephone: +91-1636-324200 Fax: +91-1636-239515
INTRODUCTION
Pharmaceutical industry is a very vital segment of the assured just on basis of quality control parameters
our health care system, which deals with manufacturing quality was assured. But this concept of TQM involves
and marketing of pharmaceuticals and biological building quality in a pharmaceutical product as it
products and medicinal devices, used for the diagnosis involve complete records such as standard operating
and treatment of diseases as well as conducts research procedures for every step, validation records, master
for development of new products for human welfare. So formula records and batch production records etc. This
maintenance of quality is very necessary to prevent review includes information about quality, quality
health hazard as many pharmaceutical products are life management, current status and need of TQM. This
saving products, so if products are not of appropriate article describes TQM as multifaceted approach for
quality then they may result in severe adverse effects or quality management of pharmaceuticals by utilizing
even death of the consumer or patient. Regulatory various quality management approaches such as quality
agencies of various countries noted that there are by design, good manufacturing practices, quality risk
deficiencies in conventional quality management management etc. leading to high quality products.
systems, so they start adopting this approach called Quality
Total Quality Management (TQM). This concept of TQM The term quality is used very commonly, this term looks
is very important for maintenance and improvement of to be very easy but it is difficult to define quality
quality and for prevention of defects1. Initially concept precisely.
of total quality control was used that quality was

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• As per ISO, it is defined as “Degree to which a set of control (FPQC) and on basis of these quality control
inherent characteristics fulfills requirements”. tests, it was concluded that whether product obtained is
Degree refers to a level to which a product or service of desired quality or not. If all parameters of final
satisfies. So, depending upon the level of satisfaction, product were found to be within limit, then it was
a product may be termed as excellent, good or poor considered as quality product but if results were found
quality product. Inherent characteristic are those to be out of specifications then product was said to be of
features that are a part of the product and are poor quality and rejected. Main drawbacks of
responsible to achieve satisfaction. Requirements traditional methods were that they do not include any
refer to the needs of customer, needs of organization process or steps for quality management of product
& those of other interested parties2. during the process. Only quality control department
• Quality has been defined in different ways by the was responsible for quality of the product, other
quality gurus as conformance to standards or departments were having no concern with the quality,
specifications; fitness for use; meeting customer’s which usually result in batch-to-batch variability6,7.
requirements or expectations etc3. Evolution of TQM
• Quality may also be defined as non-inferiority or As in conventional systems, quality only depends upon
superiority of a product. final product quality control testing. They resulted in
• Quality is a perception which may be understood increase in cost and time consumption as detection of
differently by different people. the problem is only possible at the end of the process.
The quality can be of two types Scenario changed with change in evolution and
Specification quality application of TQM, i.e. every department is concerned
This is quality from consumer point of view that how with quality management of product. Quality is checked
consumer compares it with other products in the at every step in the process and if any problem arrives it
market. is tried to be solved at that moment only. Quality does
Conformance quality not depend only on final product quality control testing
It is the measure of degree to which product or service it is monitored in every step. So it also resulted in
was produced correctly.4 increase in quality of the product and also saves cost
As per pharmaceutical industry, quality is defined as and time involved due to batch failure or due to solving
conformance to specifications of the product. The a problem involved in the process. So TQM should be
specifications are different for different products implemented by pharmaceutical industries as it result
depending upon its therapeutic effect, potency etc. in increase in quality of the product, which is very
Quality Management necessary as pharmaceutical industry is most vital part
Quality management is management of various sectors of healthcare system and also decrease time involved in
to ensure good quality of the product. Quality production, which ultimately result in decreasing cost of
management consist of four main components i.e. product.
Quality planning, Quality control, Quality assurance, Current Status
Quality improvement5. The outline of quality TQM is most widely used quality management approach
management system is given in Figure 1. worldwide. But it is not used widely in Indian
pharmaceutical industry. India is one of the largest
producers of pharmaceuticals in the world with about
20% of total production of pharmaceuticals product in
the world. The main reason for restricted application of
TQM in India is that, number of small scale companies is
more than the number of multinational companies.
Furthermore the number of WHO-GMP or US-FDA
certified industries is very less in India. These small
scale industries prefer to export to poor countries such
as African countries because of lack of quality products.
The main reason for poor quality is incomplete
application of quality management approaches such as
Fig. 1 Outline of Quality management system TQM. So TQM should be followed strictly to increase
Practices before TQM quality.
Before existence of TQM, traditional quality TQM: The Concept and Approaches
management tools, only included final product quality

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Definitions • Maintenance of copy of protocol in the laboratory in

TQM is a combined effort designed by organization to which study is to be carried out,
improve quality at every level. TQM is about meeting • Periodic inspection of facility in which study is to be
quality expectations as defined by the customer; this is carried out,
called customer-defined quality8. TQM consists of • If any change in approved protocol of the study then
efforts of organization to install and make a climate in there should be documentation and approval of the
which an organization continuously improves its ability change along with the reason for carrying out the
to deliver high-quality products and services to change, and
consumers. TQM efforts typically depend mainly on the • Documentation
previously developed techniques of quality control9.
Various definitions of TQM given by global
organizations are as follows:
As per British Standards Institution standard BS 7850-
1:1992, TQM is a management philosophy and company
practices that aim to harness the human and material
resources of an organization in the most effective way
to achieve the objectives of the organization10.
As per International Organization for
Standardization standard ISO 8402:1994, it is a
management approach of an organization centered on
quality, based on the participation of all its members
and aiming at long term success through customer
satisfaction and benefits to all members of the
organization and society11.
As per The American Society for Quality, this term was
first used to describe a management approach to quality
Fig. 2:
2 Various facets of TQM approaches
improvement. Simply, it is a management approach to
b. GCP:
GCP It is also called as ‘Good Clinical Practices’. It
long-term success through customer satisfaction. TQM
involves strict control over use of human beings in
is based on all members of an organization participating
clinical trials. The regulations for GCP are almost
in improving processes, products, services and the
similar to that of GLP. The major difference being
culture in which they work9.
that before starting study or involving any subject
REQUIREMENTS FOR IMPLEMENTATION OF TQM12, 13
or human being into the clinical trials. A complete
1. Support from management
duly filled informed consent form should be taken
2. Employee Training and motivation
from subjects along with their signature to make
3. Thorough knowledge about cause and effects of the
sure that subject is known he/she is involved in
process
clinical trials. These records should be maintained.
TQM: A multifaceted approach
If patient dropout involve during the study then
TQM is a multifaceted approach used for quality
number of dropouts along with reason of dropout
management among various branches of
from study should be documented.
pharmaceutical industry i.e. research and development,
2. Manufacturing: In production, which include
production and marketing. Various facets of TQM
manufacturing of both raw materials and API, along
approach are shown in Figure 2.
with production and packaging of dosage form.
1. Research and development:
development TQM also plays very
3. Post marketing surveillance: It also includes quality
vital role in quality management of research and
management based on market survey i.e. based on
development process. It involves following points:
post marketing surveillance and involves change
a. GLP:
GLP It is also called as ‘Good Laboratory Practices’.
control and its documentation if any change is
It involves strict control over use of animals in the
required in the approved process.
laboratory for experimentation. TQM in GLP
Approaches for TQM
involves following points:
Various approaches as practiced by industries in TQM
• Preparation of protocol or master schedule sheet of pharmaceutical process are:
for the study, Six Sigma Technique

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These are set of tools or techniques used for process • Mura- Unevenness18
improvement or quality management of process. Six The main aim of this approach is to minimize the use of
Sigma technique can improve the quality of process those resources, which do not add up to the value of
outputs by identifying and removing the causes of final product which ultimately reduce cost and increase
defects (errors) and minimizing variability in quality19. Word lean in the lean manufacturing means
manufacturing and business processes14-16. putting the right things in right place so that process
Six Sigma involves two methods:- can go on smoothly without any problem and this will
1. DMAIC:
DMAIC It is an abbreviation used for an also minimize the production of waste during the
improvement cycle, which involves 5 Phases. It is process20.
used generally for improving existing business Quality Risk Management (QRM)
processes. The phases involved are shown in Figure Quality risk management’ is defined as a method for the
3. assessment, control, communication and review of risks
to the quality of the drug (medicinal) product through
the product lifecycle where decisions can occur at any
point in the process. It is a widely used management
tool used in pharmaceutical industry, which involves
systematic procedure for identification, analysis and
control of risk involved in any ongoing process in the
industry21,22. Various parts included in quality risk
management are shown in Figure 5.

Fig. 3:
3 Various phases of improvement cycle
2. DMADV: It is used for creating new business
processes or creating a new product. It is an
abbreviation used for development cycle, which
involves 5 Phases. The phases involved are shown
in Figure 4.

Fig. 5:
5 Parts involved in quality risk management
Quality risk management includes:
• Identification of risks:
risks It involves identification of
risks before they become serious to be solved.
• Analysis of data:
data It involves analysis of risk data that
and classifying the risks based on their impact and
priority.
• Planning:
Planning Based on analysis of risk data planning for
mitigation of risks involved and making decisions
how to mitigate risks.
Fig. 4:
4 Various phases involved in creating new business • Track:
Track Monitor the plans for risk mitigation and also
Lean
Lean manufacturing monitoring risk indicators.
John Krafcik first coined this term in 198817. Lean • Control:
Control It involves strict control over risk
manufacturing do not include many tools, but it mainly mitigation plan to avoid deviation from these plans.
includes reduction of three types of waste:- • Communication:
Communication It involves communication of
• Muda- Non-value-adding work, feedback about quality risk management plans,
• Muri- Overburden, and

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their usefulness in mitigation of risks and about facilities, clothing, disposal system, sanitation, testing,
finding the emerging risks. recording of analysis, recording any reprocessing or
Quality by Design (QbD) recall, filing of change controls if any change in the
This concept was first given by Joseph M. Juran. He said process. So it is necessary to have thorough knowledge
that quality can be built in product by planning23. This about good manufacturing practices involved in the
technique is used for optimization of composition of process to ensure good quality in the product31-34.
ingredients of a formulation by use of statistical International Conference on Harmonization (ICH)
method. These statistical methods used for formulation ICH has drafted guidelines for quality risk management
optimization are approved by US FDA. ICH Q8 defines of pharmaceutical products as Q9 guidelines and for
that pharmaceutical Quality by Design (QbD) is “a pharmaceutical product development as Q8 (R2)22, 24.
systematic approach to development that begins with Q9 guidelines involve guidance about risk assessment,
predefined objectives and emphasizes product and risk control and also give guidance about various
process understanding and process control, based on methods for quality risk management such as failure
sound science and quality risk management.” mode and effect analysis (FMEA), failure mode, effects
Pharmaceutical QbD is a systematic, scientific, risk- and criticality analysis (FMECA), hazard analysis and
based, approach to pharmaceutical development that critical control points (HACCP), Preliminary Hazard
begins with predefined objectives ICH Q8 defines design Analysis (PHA), Risk ranking and filtering.
space from the concept that quality cannot be tested So these various approaches such as six sigma, lean
into product but has to be built in by design24. manufacturing, quality risk management, quality by
QbD approach requires thorough understanding of design, ISO, cGMP, ICH etc. are used to for TQM of the
product and ongoing process i.e. complete knowledge process. The main tool of TQM is strong and proper
about critical process parameters and critical quality system for documentation as any quality management
attributes. It involves design of experiments, which system is incomplete without proper or complete
involves identification of critical quality attributes and documentation. Because it is common quote that
process parameters. It determines the relationship ‘anything that is not documented or recorded means not
between critical quality attributes and process done’35. Therefore, for complete implementation of
parameters in a design space. It designs a control TQM, it is essential that everything should be properly
strategy to produce the product consistently. It involves documented in a good readable format that can be
control over these parameters to achieve desired easily understood. Specifically if there is any change in
quality25, 26. the process or any deviation in the process than a
ISO Series proper change control or deviation control should be
ISO 9000 series is a series of standards developed by filed and approved for every change or deviation from
International organization for Standardization in 1987 the validated procedure.
to maintain an effective system for quality assurance Recent Technological Advancements Supporting TQM
and quality management of manufacturing industries27, Automated approaches for real time quality management
management
28. In this, ISO 9000 is concerned with the design and of pharmaceuticals
implementation of an organization‘s quality Various automated approaches are used in many
management system is influenced by: its business industries for maintaining quality at different stages of a
environment, changes in that environment, or risks process. These are part of TQM approach as these
associated with that environment; its varying needs; its automated approaches decrease requirement of
particular objectives; the products it provides; the sampling and testing at various stages as these
processes it employs; its size and organizational analyzers and probes gave automatic reading at every
structure. It is not the intent of this International operation and give information on computer that
Standard to imply uniformity in the structure of quality ongoing process is under control or not so help in
management systems or uniformity of documentation29, increase productivity by decreasing in process sampling
30. and testing36. Few of such automated techniques for
Current Good Manufacturing Practices (cGMP) real time quality management are given below:
This is also a technique of quality management of Brimrose AOTF Multiplexed Analyser
pharmaceuticals. Various agencies have given Brimrose's rugged and high performance on-line AOTF
guidelines for good manufacturing practices such as US NIR process spectrometers deliver fast-responding and
FDA, WHO, European medicines agency schedule M in multi-component analysis for a variety of process
India. These include guidance about choosing location, applications throughout the pharmaceutical, food &

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dairy, chemical, polymer, petrochemicals, agricultural, sensors changes with temperature as because speed of
pulp & paper, wine industries and military. AOTF is an ultrasonic waves also changes with change in
optical device that is based upon the acoustic diffraction temperature. So temperature sensing systems should be
of light in an-isotropic medium. Near Infrared included in design of system for adjustment of speed of
Spectroscopy (NIR) is currently being used as a ultrasonic waves41.
quantitative tool, which relies on chemometrics to Fibre optic sensors for presence of product in packing
develop calibrations. The AOTF technology enables It consists of an amplifier and a fiber optic cable. These
these spectrometers to scan very fast and without using sensors sense the presence of product in the packaging
moving parts. This makes it the ideal tool for real-time, e.g. in tablet packing if any cavity in the pack is empty,
on-line industrial process control. These analyzers meet then it will give signal that there is absence of product
all requirements and standards for on-line applications in the cavity. In automated operations, it stops the
in and are built to work reliably even in long term harsh process if this problem occurs regularly. It is easy to
production environments37. This technology has handle and having very high switching frequency42.
following advantages over conventional methods: Miniature background suppression sensor for content
• Rugged, compact device monitoring
• No moving parts, Immune to vibrations These photoelectric sensors are used for many
• High signal-to-noise ratio advanced functions such as background suppression,
• Work even in harsh environmental conditions detection of transparent objects, contrast sensors for
Diffuse reflectance measurement color mark etc. In this, detection of product is
It is an excellent sampling tool for powdered or independent of color. It causes sharp background
crystalline materials in the mid-IR and NIR (near-infra suppression so detect the product in process very
red) spectral ranges. They can be used for monitor an precisely. These sensors are also used for web edge
ongoing process or ongoing reaction38, 39. monitoring to monitor edge of the packaging material
CIP and WIP probes during packaging43, 44.
CIP is also called clean in place. It involves cleaning of Ultrasonic sensor for adhesive strip detection
equipment with minimum involvement of the operator. These are the ultrasonic sensors, which involves use of
WIP is also known as wash in place. CIP and WIP probes ultrasonic waves for detection of adhesive strip present
are the probes which monitor this process of cleaning in on packing of products. It detects whether the adhesive
place and washing in place40. Some benefits of CIP and strip is damaged or remain intact44.
WIP probes are as follows: Anti-
Anti-counterfeiting technologies
• Procedures can be validated, Various techniques used in pharmaceutical industries
• Results are reproducible, repeatable and for detection of counterfeit drugs i.e. fake medicines are
controllable, as follows:
• Reduction of cleaning time Holographic technique
• Automatic cycles which ensure every item is It is a technique which provides a simplified means for
cleaned properly every time, consumers to analyse the authenticity of a drug.
Holograms are generated by the interference patterns
• Reduction of chemical handling,
obtained through the interaction of laser beams.
• Saving of cost including chemicals, water and
Currently available security holograms produce 2D–3D
effluent, labour time etc.,
designs45. Now a days, holograms are widely available
• Improved health and safety,
in variety of formats such as holographic shrink sleeves,
• Batch traceability and records, and
holographic induction cap seals and holographic hot
• Possibility to use stronger chemicals and higher stamping foil to identify the ‘right product’46.
temperatures etc. Radio-
Radio-frequency identification (RFID)
Sensors based technology in packaging It is one of the most promising authentication
Sensors based technology in packaging of technology based on an electronic chip that emits radio
pharmaceuticals has opened a new vista in online and frequency waves encoded with a specific ID or code47.
in-process monitoring of packaging process. Some of These specialized chip readers are used to capture the
the recently used sensors are detailed below: code as the products proceed through the supply chain
Ultrasonic sensor for filling level measurement through card readers48. The major advantage is that it
These sensors are used to measure filling level in the does not require line of sight. However the main
process. These are the sensors which survive at high
temperatures and high pressure. But sensitivity of these

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drawbacks of this technology are high cost, readability, same way that courier companies track their shipments
and lack of item-level protection47. as they wind through the shipping chain47.
Mass encryption technology CONCLUSION
It is a technique to provide a unique digital identity to TQM is the most effective tool in quality management
every product generated by a computer-based of pharmaceuticals. It is recommended strictly by
encryption engine. Digital encryption is much more many regulatory agencies but still it is not completely
secure because it every can be given its own unique implemented in all the industries especially in India.
code. The encrypted code is denoted with 16-digit As India is one of the largest exporters of
alphanumeric code, printed on packaging during pharmaceutical products across the globe, strict
manufacture and therefore provides each medicine with implementation of TQM is need of the hour in Indian
the unique identity. A major advantage advantage of
context. Despite of extensive advancement in product
this technology is that consumer can simply verify the
development for real time online production and
authenticity of the drug with the help of codes printed
packaging monitoring, their limited utilization by
on blister pack, or by entering the code online into an
internet site or via SMS47.
majority of industries remains a major area of
Track-
Track-and-
and-Trace authentication concern. In view of producing high quality medicines,
It is software that allows brand owners to manage their this article is a plea for global regulating agencies and
supply chain. Pharmaceutical companies are pharmaceutical industries for stricter enforcement
empowered to track their shipments from the factory to and sincere adoption of TQM practices in industries.
the retail level, by encryption and decryption in the ACKNOWLEDGEMENTS
Authors sincerely thank Sh. Parveen Garg, Chairman,
ISFCP for his support.
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