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An approach to TQM evaluation in pharma business

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 The TQM Journal
An approach to TQM evaluation in pharma business
Valentina Marinkovic Stana Bekcic Gordana Pejovic Tatjana Sibalija Vidosav Majstorovic Ljiljana
Tasic
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To cite this document:
Valentina Marinkovic Stana Bekcic Gordana Pejovic Tatjana Sibalija Vidosav Majstorovic Ljiljana
Tasic , (2016),"An approach to TQM evaluation in pharma business", The TQM Journal, Vol. 28 Iss 5
pp. 745 - 759
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An approach to TQM evaluation TQM

evaluation
in pharma business in pharma
business
Valentina Marinkovic
Faculty of Pharmacy, University of Belgrade, Belgrade, Serbia 745
Stana Bekcic
JUSQ, Belgrade, Serbia Received 31 October 2015
Accepted 14 April 2016
Gordana Pejovic
Faculty of Organizational Sciences, University of Belgrade, Belgrade, Serbia
Tatjana Sibalija
Metropolitan University, Belgrade, Serbia
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Vidosav Majstorovic
Faculty of Mechanical Engineering, University of Belgrade,
Belgrade, Serbia, and
Ljiljana Tasic
Faculty of Pharmacy, University of Belgrade, Belgrade, Serbia

Abstract
Purpose – The purpose of this paper is to explore the good practice (GxP) and standardised
management system integration within total quality management (TQM) paradigm in pharmaceutical
sector in Serbia. Also, the impact of all interested parties on quality management has been assessed.
Design/methodology/approach – The cross-sectional study was performed, including different
stakeholders within the pharmaceutical sector in Serbia: manufacturers, distributors, big pharma
representative offices, as well as national regulatory authority. A survey instrument was developed,
consisted of 16 questions, which were organised into four groups: questions in relation to
implementation of ISO 9001, implementation of good distribution practice/good manufacturing
practice, integration of management systems, and impact on TQM and business excellence. Total
number of participants was 121.
Findings – Standardised management systems (ISO 9001, ISO 14001, OHSAS 18001) support
companies to improve business environment and management sustainability, but this survey
indicated that it was ranked at the lower level then GxP, for pharmaceutical sector in Serbia.
Although pharmaceutical companies has faced many challenges in recent years, the survey revealed
high level of confidence in quality management systems, as well as the necessity of various
management systems integration.
Originality/value – The perception of TQM by the experts in pharmaceutical companies and
regulatory authority is wider than the common TQM definition. From pharmaceutical point of view,
TQM is a holistic approach to long-term success of organisation, oriented to all interested parties, with
focus on a public health. Risk-based approach in new revision of both ISO and GxP will facilitate
integration process towards TQM and business excellence.
Keywords Total quality management, GxP, Pharmaceutical company
Paper type Research paper

1. Introduction
Total quality management (TQM)[1] is an approach to quality management that focuses The TQM Journal
on continuously improving and sustaining quality of products and services by involving Vol. 28 No. 5, 2016
pp. 745-759
management, workforce, suppliers, and customers to meet or exceed customer © Emerald Group Publishing Limited
1754-2731
expectations (Cua et al., 2001). There is no universally accepted definition of TQM. DOI 10.1108/TQM-10-2015-0134
 TQM TQM can be viewed as a company-wide, holistic management philosophy that covers
28,5 all the business operations and seeks to continuously improve them, from resource
procurement and acquisition all the way up to the provision of customer support and
after sale service (Kaynak, 2003; Yunis et al., 2003). TQM is universally accepted as one
of the most understood change management programs (Wali et al., 2003) and it is
considered a very important factor for the long-term success of an organisation. Many
746 organisations do not comprehend clearly the concept of TQM, in terms of knowing
what are to be implemented and what area to focus on. The majority of successful
manufacturing companies have embraced TQM and realised its valuable contribution
for achieving manufacturing excellence. Organisations tend to apply TQM in different
approaches and adopt different components of TQM. The application of TQM in actual
practice is usually dependent on what quality award or programme the organisation
aims to achieve. Quality is widely recognised as one of the most important strategies or
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competitive priority for an organisational development.

Continuous quality improvement is very important for the pharmaceutical industry,
since it ensures high quality of medicinal products. Medicinal products of inadequate
quality are not only a health hazard, but also a waste of money for both government
and individual consumers. The pursuit of quality is being approached through the
concept of TQM system, which is aimed at prevention of defects rather than defects
detection (Mazumder et al., 2014). In the era of global competition a pharmaceutical
organisation needs to apply quality methodologies in the form of strategic quality
management, quality systems, quality assurance, quality control, etc. In other words,
the pharmaceutical organisation has to implement the concept of TQM (Sharma and
Kodali, 2008).
Pharmaceutical industry belongs to the highly regulated industry sectors (Bekčić
et al., 2014) where application of quality management models, within the good
manufacturing practice (GMP) and good distribution practice (GDP), was recognised by
International Conference on Harmonisation (ICH) in Q10 guidelines that are requested
by the title pharmaceutical quality system (PQS). The ICH Q10 guideline gives general
principles of GMP integration with the standardised quality management system
(QMS) ISO 9001, which should lead to a more efficient and effective product realisation
(Marinković et al., 2004). Socially accountable companies in the pharmaceutical supply
chain are faced with the fact that they must establish a growing number of standards
which are a necessary condition for doing business and survival at the market.
Globalisation and big competition in the pharmaceutical market work in favour of
those organisations that will optimise their resources, reduce expenses, and implement
new, flexible management models (Marinković and Majstorović, 2013).
All medicinal product manufacturers are obliged to have GMP certificate for
production, and GDP certificate for distribution. At the same time, there are also
management systems standards, such as ISO 9001 for quality, ISO 14001 for
environment, occupational health and safety standard (OHSAS 18001) and information
security (ISO 27001) standard, as well as ISO 17025 for testing laboratories performing
the quality control of medicines, that should support the organisation performance at
the relevant market. These standards are quickly gaining international acceptance and
are becoming a necessary condition for doing business. Today, the most commonly
implemented standards are the ISO 9000, 14000, 17000, 18000, 20000, 22000, 27000,
31000 series, and others. However, the main question that arises is how to implement
these standards in an integrative manner? One of the answers lies in integrated
management systems (IMS) which should link at least two standards. Pharmaceutical
 organisation should address the demands of the market imposing ISO standards as TQM
control instruments, and also they should address the legislation obliging them to evaluation
implement GMP and GDP. While ISO standards allow certain amount of freedom in
fulfilling requirements, leaving to the organisations to find answers to the requirements
in pharma
on their own, Good practices (GxPs) give concrete responses to the set of requirements business
and impose them as the only ones acceptable. Reconciliation of these two currents that
have an impact on the IMS architecture and, at the same time, continuous cost 747
reduction to make the products available and affordable, represent a great challenge for
the management and IMS engineers, and a field in which further research is expected
(Bekčić et al., 2013).
GMP and the good laboratory practices (GLP) are two important quality
management tools in the pharmaceutical industry. When GMP and GLP are
implemented, robust quality assurance systems are established and operate to increase
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reliability. These systems must be well designed, implemented and controlled, and
adequate personnel and equipment are required in order to meet quality objectives[2].
Implementation of the PQS is not only a regulatory requirement or a marketing move,
but it is a paradigm for the development and improvement of business performance.
There are about 20 pharmaceutical manufacturers in Serbia, most of which have at
least one certificate confirming implementation of QMS model (Marinković et al., 2004).
Nowadays, GxPs, as well as implementation of different standardised management
systems are mandatory for all companies in pharmaceutical supply chain, not only in
manufacturing organisations. Therefore, it is important to consider the role of
regulatory authorities in each country, since the main aim of medicines regulation is
ensuring the safety, efficacy, quality, and rational use of medicines that are available to
the population. The effectiveness of medicines regulation should be judged according
to the extent to which the medicines regulatory authority achieves this aim. One way to
measure medicines regulation effectiveness is by relating the final outcomes of
medicines regulation to various regulatory functions and by developing measures to
capture regulation performance. To accomplish all the regulatory authority’s
objectives, one possible approach is to implement CQI or TQM (Pejović et al., 2016).
Serbian pharmaceutical companies are mostly subsidiaries of global,
multinational companies. Related to the new business model, outsource of some
pharmaceutical manufacturing processes is accepted by Serbian companies. Only
few pharmaceutical plants in Serbia perform the full manufacturing process, from
active pharmaceutical ingredients through bulk to the final products.
Contract manufacturing of pharmaceuticals influences the quality risk (Gray et al.,
2011), so implementation and understanding of pharmaceutical quality standards is a
big challenge for all subjects in pharmaceutical supply chain.
The aim of this paper is the investigation of GxP and standardised management
system integration on TQM paradigm in pharmaceutical sector in Serbia, including the
society prospective.

2. Theoretical background and study methodology

TQM and associated quality improvement initiatives have gained wide acceptance in
the manufacturing environment. In recent years, some service organisations in
different service industries such as healthcare, insurance, hospitality, among
others, have shown interest in TQM (Hasan and Kerr, 2003). This interest may be
attributed to the positive impact of TQM on the strategic and operational facets of
organisational performance.
 TQM TQM has a great potential to address quality problems in a wide range of industries
28,5 and improve the organisational performance. Various studies have suggested quite a
large number of factors/elements/constructs/dimensions of TQM implementation.
Some of them have appeared more frequently than others. TQM and performance
improvement have a positive relationship. In particular, the Malcolm Baldrige quality
award criterion confirms such relationship between quality management practices and
748 business results (Gorji Ali and Farooquie, 2011).
Yasin et al. have developed the special questionnaire to explore current TQM
implementation practices, their operational and strategic outcomes and benefits in
various service organisations, among which were several pharmaceutical
organisations. The study revealed that service firms must modify and adjust the
tools and techniques of TQM to bring them in line with the unique operational
components of the specific industry (Mahmoud et al., 2004).
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As published in recent studies, pharmaceutical industry has gone far in

implementing TQM principles. The evolution of quality principles and how they are
implemented in the pharmaceutical industry has been analysed in various surveys.
The special emphasis is put on the PQS and concepts, with the future role of TQM as a
model for the business excellence improvement (Korakianiti and Rekkas, 2011). Also,
research on assurance of the pharmaceutical product safety through the
implementation of various TQM principles and methodologies for process
improvement has been conducted. The survey has been performed in order to
understand the employees’ perception of the impact of TQM on their roles within
the organisation and how employees perceived the effectiveness of the quality
processes in Pakistani pharmaceutical industry. This research confirmed that there
is a positive and significant relationship between employee’s perceptions and TQM,
and significant relationship between perceived effectiveness and quality processes
(Rana et al., 2009).
Calvin London (2005) studied management effects on quality policy implementation
in pharmaceutical companies, and the nature and extent of structured programs for
policy implementation. The study revealed that the levels of commitment and
involvement shown by management (both senior and middle management) had
significant effects on the success of the quality policies. Where the perceived levels of
support were lowest, policies took a long time to be implemented; they consumed
resources and resulted in approved policies that did little to meet their overall
objectives for the company. The role of senior management is one of the most
significant factors in creating successful cultural change and policies need to originate
from a senior management.
A study by Salaheldin (2009) indicates that there are many empirical studies which
examine TQM practices performance relationships in large companies, but the small
and medium companies still need more attention of researchers (Salaheldin, 2009).
Quality literature abounds with successful examples and cases of western economies
adopting quality initiatives, but very little has been reported on quality issues in
developing countries. Only recently, reports are appearing on quality studies relating to
work culture, impacts of government policies, technological diversification, etc., specific
to the developing countries.
While the literature concerning service quality dimensions in the healthcare
industry is replete with studies from the developed world, researchers from developing
countries have been exploring the applicability of the related models and frameworks
in their specific context.
 Zakuan et al. (2010) suggest that despite the number of publications and quantity of TQM
research on TQM, there is actually little empirical work that has been carried out in the evaluation
developing countries. Therefore, a self-designed questionnaire for the review of various
quality management practices including ISO implementation in Indian pharmaceutical
in pharma
industries has been developed, to explore the relationship between TQM practices and business
performance of the company, and to identify and analyse the significant factors
affecting TQM implementation in Indian pharmaceutical industries. The study 749
concluded that the main factors affecting the implementation of TQM are: top
management commitment, leadership, quality management, people management and
training, customer focus and supplier quality (Singh and Dhalla, 2010).
Also, there are some new practices that are recently applied to the pharmaceutical
industry, though they are widely applied in non-pharmaceutical industries, such as:
lean manufacturing; Six Sigma; TQM. Haleem et al. (2015) suggested that both
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managers at the pharmaceutical industry and literature should focus on the adoption of
such practices into the pharmaceutical industry. New case studies should be done to
prove the feasibility of such new practices.
Research dealing with the empirical relationships between TQM and the operational
and strategic facets of organisational performance in different service operational
settings has not been forthcoming. Such research is needed to give service managers
the bottom-line justification for implementing TQM.
To assess QMS in pharma business activities in Serbia, this quantitative study has
been designed.
The prospective cross-sectional study was conducted during February and March
2015 on a convenient sample of marketing authorisation holders: five organisations
from pharmaceutical industry (local manufacturers), four organisations from big
pharmaceutical industry (representative offices), and four distribution pharmaceutical
companies. Also, the same questionnaire was sent to Serbian drug regulatory authority
which is assessing marketing authorisation (MA) dossiers and is issuing MA
approvals. The attitude and perception of Drug Agency experts about QMS is very
important, because of their role in the public health and patient safety.
The study was conducted using a specially constructed, anonymous questionnaire
(see the Appendix). The questionnaire is sent to the heads of quality, who were asked to
distribute it to the key personnel in pharmaceutical companies. Total number of
collected questionnaires was 121. The data analysis was performed using SPSS
programme (version 18).

3. Results and discussion

The questionnaire used in the research consisted of 16 questions that were organised
into four quality management concepts, as shown in the Appendix: IS (implementation
of ISO 9001), questions 1-5; GP (implementation of GDP/GMP), questions 6-10; IM
(integration of management systems), questions 11-13, and BE (impact on TQM and
business excellence), questions 14-16.
All items were measured on a five-level Likert scale, where the lowest point (1)
means fully disagree or fully negative answer; the point (2) means tend to disagree or
negative answer; the midpoint (3) means middle degree or neither positive nor negative
answer; the point (4) means tend to agree or positive answer; and the highest point (5)
means fully agree or fully positive answer.
The summary of survey results in terms of frequencies and percentages of answers
for all 16 items (questions, indicators) considered in the survey is presented in the Table I.
 Downloaded by Professor Tatjana Sibalija At 05:22 26 August 2016 (PT)

28,5

750

results
TQM

Table I.
Summary of survey
Total Number of answers
Question number Number of answers (1) – Number of answers (2) (3) – middle degree or Number of answers Number of answers (5)
Group (indicator, of fully disagree or fully – tend to disagree or neither positive nor (4) – tend to agree or – fully agree or fully
(construct) item) answers negative answer negative answer negative answer positive answer positive answer

IS IS1 121 1 (0.8%) 1 (0.8%) 2 (1.7%) 53 (43.8%) 64 (52.9%)

IS2 121 1 (0.8%) 1 (0.8%) 5 (4.1%) 43 (35.5%) 71 (58.7%)
IS3 121 1 (0.8%) 1 (0.8%) 2 (1.7%) 52 (43.0%) 65 (53.7%)
IS4 121 0 (0.0%) 17 (14.0%) 13 (10.7%) 55 (45.5%) 36 (29.8%)
IS5 121 2 (1.7%) 13 (10.7%) 10 (8.3%) 65 (53.7%) 31 (25.6%)
GP GP1 121 1 (0.8%) 1 (0.8%) 3 (2.5%) 31 (25.6%) 85 (70.2%)
GP2 121 2 (1.7%) 4 (3.3%) 18 (14.9%) 61 (50.4%) 36 (29.8%)
GP3 121 1 (0.8%) 4 (3.3%) 17 (14.0%) 49 (40.5%) 50 (41.3%)
GP4 121 0 (0.0%) 1 (0.8%) 9 (7.4%) 52 (43.0%) 59 (48.8%)
GP5 121 1 (0.8%) 2 (1.7%) 3 (2.5%) 30 (24.8%) 85 (70.2%)
IM IM1 121 0 (0.0%) 3 (2.5%) 8 (6.6%) 67 (55.4%) 43 (35.5%)
IM2 121 1 ((0.8%) 6 (5.0%) 5 (4.1%) 60 (49.6%) 49 (40.5%)
IM3 121 0 (0.0%) 1 (0.8%) 25 (20.7%) 53 (43.8%) 42 (34.7%)
BE BE1 121 2 (1.7%) 2 (1.7%) 4 (3.3%) 27 (22.3%) 86 (71.1%)
BE2 121 1 (0.8%) 4 (3.3%) 9 (7.4%) 25 (20.7%) 82 (67.8%)
BE3 121 2 (1.7%) 7 (5.8%) 3 (2.5%) 28 (23.1%) 81 (66.9%)
 Most of the items were rated highly (fully agree) which indicates that the quality is TQM
perceived as very important business function. The questions BE1, GP1, and GP5 evaluation
received the highest rating (⩾85 per cent) which indicates that GxP implementation is
the most important quality factor in pharma companies, within the complex supply
in pharma
chain. The data analysis was performed using several statistics that are commonly business
used in the previous related studies (Kumar et al., 2009; Grigg and Mann, 2008),
as follows. 751
First, the mean and standard deviation were reported for each indicator within the
observed four groups (constructs), and the means were ranked. Then, the coefficient of
variation is calculated as a ratio of standard deviation to mean (coefficient of
variation ¼ Standard deviation/Mean). The above statistics calculated for all variables
(indicator) within four constructs IS, GP, IM, and BE are presented in Tables I, II, III and
IV, respectively. The coefficient of variation is reported for each variable (indicator) to
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confirm the reliability of a measure. As a rule of thumb, the coefficient should be less
than 0.3 to confirm the existence of a true mean among the sample (Kumar et al., 2009),
which is satisfied for all coefficient of variation values, as presented in Tables I-IV.
Then, the overall model was analysed. The analysis of variance was performed and
showed F-value (for the overall model) of 17.97 at zero significance. Given that the
questionnaire involves the use of multiplicative scale, model reliability was tested using
Cronbach’s α coefficient. The overall Cronbach’s α for the observed 16 items
(indicators) that measure performance of four groups (constructs) was found to be
0.901, which is higher than the required minimal value of 0.7. Finally, the reliability
analysis of constructs used in the model was conducted by calculating their

Rank Mean SD Coefficient of variation Cronbach’s α

IS1 3 4.47 0.659 0.15 0.724

IS2 1 4.50 0.697 0.15
IS3 2 4.48 0.660 0.15
IS4 4 3.91 0.983 0.25 Table II.
IS5 5 3.91 0.957 0.24 IS-related indicators

Rank Mean SD Coefficient of variation Cronbach’s α

GP1 1 4.64 0.658 0.14 0.821

GP2 5 4.03 0.856 0.21
GP3 4 4.18 0.856 0.20
GP4 3 4.40 0.664 0.15 Table III.
GP5 2 4.62 0.698 0.15 GP-related indicators

Rank Mean SD Coefficient of variation Cronbach’s α

IS1 1 4.24 0.683 0.16 0.696

IS2 2 4.24 0.817 0.19 Table IV.
IS3 3 4.12 0.759 0.18 IM-related indicators
 TQM Cronbach’s α values. The reliability test results for the observed four constructs IS, GP,
28,5 IM, and BE are reported in Tables I, II, III and IV, respectively. The results show that
the overall Cronbach’s α value and the Cronbach’s α values for four constructs exceed
the threshold point of 0.7 suggested by Nunnally (1967), that is very encouraging in
terms of the model reliability (Prajogo and Sohal, 2003). It is important to note that for
the construct IM Cronbach’s α value equals 0.7 which can be accepted.
752 The ranking of answers about ISO 9001 implementation is given in Table II. The
item IS2 had the highest mean value which indicated that implementation of ISO 9001
improves business relationship. The lowest mean value (3.91) had items IS4 and IS5.
Pharmaceutical companies did not recognise ISO 9001 as a direct predictor of
business success, because other standards are mandatory for different licences
(MA, manufacturing authorisation, wholesale authorisation).
There was not much difference between the means of all indicators, i.e. components
of IS construct. The obtained value of Cronbach’s α (α ¼ 0.724) showed that the
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components of IS are all related, which confirms the homogeneity of the set of
components used to express the construct IS.
The analysis of inter-item correlation revealed that the highest correlation is
between the items, i.e. indicators IS4 and IS5 (correlation coefficient is 0.682), followed
by the correlation between the indicators IS2 and IS3 (correlation coefficient is 0.649),
correlation between IS1 and IS3 (correlation coefficient is 0.607), and correlation
between IS1 and IS2 (correlation coefficient is 0.549). The other correlations,
i.e. correlations between indicators that are not listed above are significantly lower
(the corresponding correlation coefficients are between 0.118 and 0.197). The reason for
the low correlation can be described by the fact that respondents did not link ISO 9001
directly to GxP, although PQS (GMP part) suggested connection of these standards[3].
Answers about GxP in pharma business (GP) are presented in Table III.
The reliability analysis for the construct GP resulted in a rather high Cronbach’s
α value (α ¼ 0.821), confirming the homogeneity of the set of indicators used to
present the construct GP (in other words, the indicators GP1, GP2, GP3, GP4, and GP5
are all related).
The inter-item correlation matrix showed that the highest correlation is between the
indicators GP2 and GP3 (correlation coefficient is 0.708), GP1 and GP5 (correlation
coefficient is 0.694), GP3 and GP4 (correlation coefficient is 0.605), GP1 and GP4
(correlation coefficient is 0.542), and GP4 and GP5 (correlation coefficient is 0.507). The
other correlations not mentioned above are lower, with correlation coefficients between
0.256 and 0.446. Key personnel in pharmaceutical companies are traditionally well
trained according GMP guidelines. Recently, GDP became mandatory standard, so
high correlation among the answers in this section is expected.
Although pharmaceutical companies are phased with different standardised
management systems (ISO 14001, OHSAS 18001, ISO 27001, etc.), integration models
are not widely adopted (Bekčić et al., 2013).
Answers about GxP in integration of management systems (IM) in pharmaceutical
business are presented in Table IV. For the IM construct, the reliability analysis
showed the Cronbach’s α that equals the threshold point of 0.7. Therefore,
the homogeneity of the set IM1, IM2 and IM3 that is used to present the construct
IM is acceptable.
The inter-item correlation analysis showed that the correlation between the
indicators IM1 and IM2 (correlation coefficient 0.478) is higher than the
correlation between IM1 and IM3 (correlation coefficient 0.392) and the correlation
 between IM2 and IM3 (correlation coefficient 0.382). However, all three TQM
correlations are relatively low in comparison to the correlations between indicators evaluation
for other three constructs IS, GP, and BE. Reason of these low correlations
can be found in respondents’ insufficient and non-homogenous knowledge of
in pharma
management systems integration. Standardised management systems in their new business
versions are approaching each other, and development of an integration model will be
the new phase of PQS. 753
The highest mean value (4.53) was noticed for the answers in the group
BE (Table V).
The considered three indicators BE1, BE2, and BE3 that are used to depict the
construct BE are related (Cronbach’s α ¼ 0.815), which means that they measure the
same concept.
The analysis of correlation between indicators of the construct BE showed that the
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highest correlation is between BE2 and BE3 (correlation coefficient is 0.639), followed
by the correlation between BE1 and BE2 (correlation coefficient 0.587), that is slightly
higher that the correlation between BE1 and BE3 (correlation coefficient 0.561). These
results confirm the fact that implementation of quality standards enables better
product positioning. Quality of pharmaceuticals is complementary to the patient safety,
so implementation of quality standards is the main predictor of the appropriate quality
of healthcare.
The perception of TQM by experts in pharmaceutical companies and regulatory
authority is wider than the common TQM definition. From the pharmaceutical point of
view, TQM is a holistic approach to long-term success of organisation, oriented to all
interested parties, and focused on public health. Our study showed that mandatory
quality standards (GxP) were well accepted and implemented, while voluntary (ISO)
standards were not recognised and integrated enough in a quality organisation
structure and policies.
The specificity of our finding was that implementation of GxP was realised using
tools and predictor of implementation of ISO standards and TQM. As long as the GMP
and GDP are mandatory, we assume that the regulatory authority will be crucial link
for the customer focus. This observation may correlate with the quality culture of the
developing countries.

4. Conclusion
Earlier this year, in Serbia there were major changes and difficulties in the
pharmaceutical business, due to price erosion of medicines and loss of privileges of
domestic producers. Many pharmaceutical companies have reduced their operations
and lay off many workers. At the same time, demands and requirements about quality
management standards are increasing. Implementation of GxP is now mandatory not
only in pharmaceutical industry but also in other pharmaceutical organisations in
pharmaceutical supply chain.

Rank Mean SD Coefficient of variation Cronbach’s α

BE1 1 4.60 0.781 0.17 0.815

BE2 2 4.51 0.838 0.19 Table V.
BE3 3 4.48 0.923 0.21 BE-related indicators
 TQM However, the survey conducted among employees in the pharmaceutical sector in
28,5 Serbia has shown that the confidence in QMS remains at a high level. In general,
standardised management systems (ISO 9001, ISO 14001, OHSAS 18001) support
companies to improve business environment and management sustainability. But, this
study showed that implementation of GxP is more important that the implementation
of QMS in pharma business in Serbia. Furthermore, GxP has been realised as a basic
754 element for further integration towards to TQM.
Medicine product quality is inseparable from the safety of a patient; hence,
TQM in the pharma business has a wider dimension than for the other industrial
sectors. This is reflected in the appreciation of all stakeholders, in particular
regulatory authorities. The Regulatory authorities represent the link between
pharmaceutical organisations and health professionals, and, at the end – the
patients. This shows that customer focus in pharma business is much more complex
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than in other sectors.

Standardised management systems in their new versions are approaching each
other, and development of an integrated model will be the new phase of PQS. Also, the
convergence of GxP and ISO standards trough risk-based approach will enable better
integration and recognition of TQM benefits by senior management. For better
understanding of QMS infrastructure, TQM perspective for pharmaceutical companies
has to be extended to incorporate the public health values.
Further researches and challenges in this field will be oriented to empower the
quality performance indicators within the pharmaceutical organisation to be able to
monitor the health outcomes, rather than customer satisfaction.

Glossary

ANOVA analysis of variance

APIs active pharmaceutical ingredients
CQI continuous quality improvement
ICH International Conference on Harmonisation
IMS integrated management system
ISO International Organisation for Standardisation
GCLP good clinical laboratory practices
GDP good distribution practice
GLP good laboratory practices
GMP good manufacturing practice
GxP good practices
MA marketing authorisation
MAH marketing authorisation holders
PQS pharmaceutical quality system
QMS quality management system
SPSS statistical package/software
TQM total quality management
BE impact on TQM and business excellence
GP implementation of GDP/GMP
IM integration of management systems
IS implementation of ISO 9001
 Notes
TQM
1. Abbreviations are listed in Glossary. evaluation
2. The Sources of Quality in the Pharmaceutical Industry, available at: www.ucema.edu.ar/ in pharma
publicaciones/documentos/284.pdf (accessed 14 April 2015). business
3. ICH Q10 pharmaceutical quality system, available at: www.gmp-compliance.org/guidemgr/
files/ICH%20Q10%20STEP%204.PDF (accessed 14 April 2015).
755
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Agus, A., Krishnan, S.K. and Kadir, S.L.S.A. (2000), “The structural impact of TQM on financial
performance relative to competitors through customer satisfaction: a study of Malaysian
manufacturing companies”, Total Quality Management, Vol. 11 Nos 4-6, pp. 808-819.
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competitive advantage”, International Journal of Quality & Reliability Management, Vol. 24
No. 5, pp. 442-471.
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Appendix
evaluation

business
in pharma
TQM

757
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TQM
 About the authors TQM
Valentina Marinkovic, BSc, MSc, PhD, Pharm Spec, built her professional career in two directions – evaluation
academic and work in practice. She acquired title of an Associate Professor at the Faculty of
Technology in Leskovac, University of Nis, and she established their practical experience in the in pharma
pharmaceutical and chemical industries. She has published more than 130 publications in scientific business
and professional literature. She is theVice-President of the Untied Association for Quality in Serbia
( JUSK) since 2009 year. Nowadays, she is an Assistant Professor of Pharmacy, University of
Belgrade, Department of Social Pharmacy and Pharmaceutical Legislation. Valentina Marinkovic is 759
the corresponding author and can be contacted at: vanja.marinkovic63@gmail.com
Stana Bekcic was born in Belgrade. She holds Bsc, and Msc at the Faculty of Technology,
Major: Biochemical Engineering and Biotechnology in Belgrade. Specialist in Biotechnology since
2004 she is on PhD programme at the Faculty of Pharmacy in Belgrade. She is a Member of the
Untied Association for Quality in Serbia ( JUSK) since 2011. Her professional and research career
began and developed over 17 years in Institute of Virology, Vaccines and Sera, “Torlak”, Belgrade
and had the leadership on QA positions more than nine years. She is a Quality Assurance Manager
Downloaded by Professor Tatjana Sibalija At 05:22 26 August 2016 (PT)

(ECA)-Pharmaceutical Production (2009) certified and IRCA certified Lead Auditor.

Gordana Pejovic was born in Belgrade. In 2012 she received PhD in Organisational Science at
the Faculty of Organizational Science, University of Belgrade. She holds BSc, MSc and
specialisation in Drug Analysis and Control at the Faculty of Pharmacy, University of Belgrade.
She is a Quality Management Manager at the Medicines and Medical Devices Agency of Serbia, as
well as an Assistant Professor at the University of Belgrade – Faculty of Organisational Science.
Pejovic is IRCA certified Lead Auditor. Also, she is an External Auditor for Quality Management
Systems in European Directorate for the Quality of Medicines & HealthCare, Council of Europe.
Tatjana Sibalija is an Associate Professor at the Metropolitan University, Belgrade. Her research
interest includes production and industrial engineering, quality management, multi-objective
optimisation, artificial intelligence, intelligent manufacturing, etc. She is a Member of the Managing
Board of National Organisation for Quality ( JUSK), President of National Committee for Six Sigma,
and Vice-President of EU ETP ManuFuture national team. She is the author of eight books and over
90 papers published in peer-reviewed international journals/presented at refereed international
conferences; member of numerous scientific programme committees of international conferences;
reviewer for many leading scientific journals and conferences, and FP7/Horizon 2020 expert.
Vidosav Majstorovic is a Full Professor and the Chair of Production Engineering at the MEF
of the Belgrade University. He is a Professor for Quality Management, Manufacturing Metrology
and Cutting Processes, and the Chief of Laboratory for Production Metrology and TQM and also
of the International Centre for Excellence of QM and Production Metrology. Altogether he
published over 500 papers, and presented/published over 290 papers at the international
conferences, international journals and books. He is a Member of the editorial board of over 20
international journals and IPC member around the world. He is a CIRP Fellow Member and
Active Member of IMEKO, IFIP, IFAC, etc.
Ljiljana Tasic, BSc, MSc, PhD, Pharm Spec, MA, started her career in Institute Galenika and
continued at the University of Belgrade. She is the founder of the Department of Social Pharmacy
and Pharmaceutical Legislation at the University of Belgrade – Faculty of Pharmacy, where she
is a Full Professor. She has published over 170 scientific publications and communications, and
the author and co-author of six books. She is a Member of the RSC to improve the quality of
healthcare, the Association of Serbian pharmaceutical companies, UASQ, Pharmaceutical
Chamber of Serbia, and the International Association of FIP, ISPOR, PCNE.

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