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5th International Working Conference ’’ Total Quality Management’’ , 1st- 4th June, 2009, Belgrade.

Integrated Management Systems in the Pharmaceutical Company

“ZDRAVLJE- Actavis”

Ass. Prof. Dr Valentina Marinkovic,

Quality Department, ‘ZDRAVLJE- Actavis”, 16000 Leskovac, Serbia


Abstract: The front-runner companies in pharmaceutical world industry are moving towards a more
sustainable management of their production and products. The traditional management focus on GMP
has been extended with other aspects and standards, such as ISO 9001, ISO 14001, BS 25999, SA
8000, OHSAS 18001. Up till recently there has been a major difference between especially the quality
and the environmental standards, when it comes to underlying understanding of organizations.
However, since the new version of ISO 9000:2000 the similarities have increased regarding the core
aspect of management. Also, after adoption of ICH guidance Q 10, GMP and ISO 9000 are under the
same roof.
This paper discusses the development of standard for Integrated Management Systems as well as
organisational and auditing challenges with IMS in the pharmaceutical company ZDRAVLJE- Actavis

Keywords: Integration, Management Systems, Pharmaceutical Industry

1. INTRODUCTION developed to improve the coherence with ISO

For pharmaceutical Industries, implementation
of GMP regulations is “do or dye” fact, The connection between EMAS (published in
because of legal and regulatory requirements. year 2000) and ISO 14001 is made clear
Liability in connection with quality, (Jorgensen T.H., et al., 2004).
environmental, occupational health and safety
and social accountability is increasingly OHSAS 18001 is developed to be compatible
important for the company image. In the same with ISO 9000:1994 and ISO 14001:1996.
time, we have the new standards for business
continuity management and risk management SA 8000 can be combined with ISO 9001:
to support the company to survive in tough 2000, ISO 14001: 1996 and OHSAS 18001.
economic environment.
By having certified management systems ICH Q 10 is developed to be integration of
covering these areas, the companies give a GMP and ISO 90001 and it will be Annex 21
signal of liability and concern for stakeholder of EU GMP .
ISO 31000 and ICH Q9 (Annex 20 EU GMP)
With the revision and new editions of the have the similar framework of implementation.
different standards for management systems,
the systems have an increased number of PAS 99:2006 presents the BSI guideline for
similarities (Jorgensen, T.H., 2002). Although integration QMS, EMS, OHSAS, ISO/TEC
a standard for an Integrated Management 20000, ISO 22000 and ISO/TEC 27001, using
Systems is still absent in ISO, the following the common principles and elements.
initiatives are promoting the integration: - policy,
- planning,
ISO 9001:2000 have more focus on continuous - operation,
improvements, being one of the foundations of - performances,
the environmental as well as the health and - improvements,
safety management systems. - management review.

The new edition of ISO 14001 has been

5th International Working Conference ’’ Total Quality Management’’ , 1st- 4th June, 2009, Belgrade.

is the third largest producer of pharmaceutical

The main reason for integration of products in Serbia. ZDRAVLJE a.d. was
management systems in ZDRAVLJE –Actavis founded in 1953. In January 2003,
Company are: ZDRAVLJE was privatized by Pharmaco
(Iceland), which changed its name to Actavis
- Documentation control, as well as in May 2004. Since then, ZDRAVLJE a.d. has
minimization of records and been operating as a member of Actavis Group.
documents. The main challenge in one multinational
- Cost saving by optimization of time companies was two levels of integration:
and resources assigned to the systems.
- More focus on interrelations as well as • Corrporate (group) level
synergies. • Local (company) level

In this paper the integration model (case study- First phase of management systems integration
ZDRAVLJE- Actavis) is presented with the on the corporate level was done in 2005 by
key elements and tools for following integration of quality standards- GMP and ISO
management systems: 9001, EHS standards- ISO 14001 and OHSAS
• QMS (ISO 9001 and GMP) 18001 trough the Corporate Manual. We
• EHS (ISO 14001 and OHSAS integrated top management commitment,
18001) documentation and training.
• BCM (BS 25999) It was the framework of integration for all
• Codex Alimentarius other management systems.
• CE mark (ISO 13485) Second phase of integration was planing,
monitoring and review of objectives and
Presented model is capable for further KPSIs (in 2006), trough approved templaits
integrations: and reviewing process on corporate and
• Social accountability (SA 8000) company level.
• Information security (ISO/IEC 27001)
• Risk management (ISO 31000) Third phase of integration was establishing of
CAPA register and continuouise improvement
• Laboratory accreditation (ISO 17025)
process in ZDRAVLJE level (in 2008).
Steps forward will be common internal audits
(plan for 2009) and certification of integrated
There are a number of differences between the
management systems: ISO 9001, ISO 14001
six management systems, as well as several
and OHSAS 18001.
similarities, where it is sufficient to handle the
different areas in the same way (Shaw, O.,
2. 1. Top management commitment
2003; Matias et al., 2004).
The similarities between these management
The main document on the corrporate level is
systems are the key elements of integration:
the Corporate Manual that describes key
principles of management system.
1. Top management commitment
2. Documentation and records control
A management system is a proven framework
3. Planning of objectives and Key
for managing and continually improving the
Performance Indicators (KPI)
organization's policies, procedures and
4. CAPA(corrective action preventive
action) and CACI (corrective action
The best businesses work as complete units
continuous improvement) system
with a shared vision. This may encompass
5. Training procedures
information sharing, benchmarking, team
6. Audits
working and working to the highest quality and
7. Management review
environmental principles.
A management system helps the organization
It also follows the Plan, Do, Check, Act,
to achieve these goals through a number of
approach of all the major management systems
strategies, including process optimization,
requirements standards (Wilkinson, G et al.,
management focus and disciplined
2002; Majstorovic, V.D., 2008)
management thinking.
Pharmaceutical Industry ZDRAVLJE a.d.

5th International Working Conference ’’ Total Quality Management’’ , 1st- 4th June, 2009, Belgrade.

Implementing the Corporate Manual, all - annual „kick off“ meetings,

Actavis leaders committed that they would - company newspaper,
follow quality and EHS principles and all - internal web site.
standards related to these principles.
Comunicatation of the mission and policy in 2.2. Documentation and records control
Actavis, first class generic company is
mitigated to all employees (cca 11 0000) Structure of Corporate Manual is preseted in
through: the Figure 1.

Quality & Corporate

EHS Mission Quality &
EHS Systems
Corporate Policies

Corporate General Procedures

Company Quality Company Standard Corporate Directives

Operating Procedures and Guidelines
and EHS Systems

Company Confirmation Corporate Templates


Figure 1 – Integration of documentation – corporate and company levels

Corporate level documents are policies, - Quality Manual

general procedures, directives and guidelines. - EHS Manual
Templates for all documents, as well as - 25 Master Plans and programs
approval matrix is also defined on corporate - 879 SOPs
level. Corporate documentation gives the basic - 1023 Records
principle of GMP, ISO 9001, ISO 14001,
18001 and BCM. Documentation Management Intention and Plan for 2009 is to put
is in accordance of Change Control Procedure . together quality and EHS issues under one
Certification of relevant standards has to roof- Company Manual.
be performed on the company level. So, each
company within the group has own 2.3. Training procedures
documentation system. Standard Operation
Procedure (SOPs) , records and confirmation Training of employees is defined on
sheets describes process details and corporate (Procedure) and company level
responsibilities in the company. (SOPs).
In ZDRAVLJE , all documents should be Annual training plan has to be approved by
finally authorized by QA manager, but also local Quality and EHS Board..
reviewed by EHS manager. Induction training for new employee and
trainings for contractors and visitors are also
Current status in ZDRAVLJE is: documented.

5th International Working Conference ’’ Total Quality Management’’ , 1st- 4th June, 2009, Belgrade.

2.4. Planning of objectives and and regulatory requirements, as well as

Key Performance Indicators (KPI) financial, operational and business
Each year, Corporate Management Board
gives the main objectives and key Corporate, company and personal objectives
performances indicators according the core have to be in correlation.
corporate values, technological capacity, legal


- Corporate Quality and EHS
- Local management teams

Quality and EHS Board


Figure 2. Continuous improvement process

Responsibilities, activities and due dates 2.4. Management review

are documented.
Corporate and company objectives are Reporting of KPIs is in the same time
stated in Annual Plans, but objectives of monitoring of objectives.
each employee is stated in separate record- If sometimes KPIs are not achieved, it
per 4ma (Fig 2). raises non conformance report and defined
new corrective and preventive actions
2.3. CAPA system and continuous
improvement process. Quality & EHS Board, consisted of key
top management members, makes decision
The consequence of non conformance about objection revision, as well as
and deviations is appropriate corrective continuous improvement objections.
action plan. In ZDRAVLJE-Actavis, all
corrective and prevention actions are
documented in CAPA register. 3. INTEGRATION TOOLS
CAPA register is periodically monitored
by management on local Quality & EHS The powerful integration tools to build the
Board. robust management systems are:
Through CAPA system, company
management can monitor and review the - knowledge management (KM) and
objectives. It is part of continuous - risk management (RM)
improvement process (Fig. 2).

5th International Working Conference ’’ Total Quality Management’’ , 1st- 4th June, 2009, Belgrade.

To achive business objectives, the knowledge Internal audits and certification, according
management and risk management are the different management systems are still separate
main enablers (ICH Q 10). issues and challenge for next years. Reason of
Decision making process needs the risk based that is very slow change in certification bodies
approach. and regulatory authority’s approach and
KM is sistematic approach to collect, expectation.
analysing, keeping and explore information
conected with product, processes and
component. The source of knowledge icluded,
former knowledge, pharmaceutical References
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ZDRAVLJE ad, as a part of multinational ICH Q10 on Pharmaceutical Quality System
Actavis group built the own, robust model of (2008).
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