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Bulletin of Science of Siberia. 2013. No. 4 (10) http://sjs.tpu.ru

UDC 661.12:658.62.018

QUALITY ASSURANCE SYSTEM IN

PHARMACEUTICAL PRODUCTION.
Yanushevskaya Marina Niko-
HACCP SYSTEM
laevna,older teaching-
Chair of the department physical
T.B. Buglevskaya., M.N. Yanushevskaya
quality control methods and
instrumentsInstitute indestructible

roaming control TPU. Tomsk Polytechnic University

Email: yanushevskaj@tpu.ru Email:yanushevskaj@tpu.ru
Region scientific interests:
integrated QMS, certification, The article deals with the issues of ensuring the safety of
internal audits: medicines. Achieving this goal is associated with the use of
Problems and perspectives European quality management methods, the implementation
process approach, business and certification of quality systems in accordance with
process modeling. international standards ISO 9000, GMP, GLP, GCP. The Hazard
Buglevskaya Tatyana Borisovna, Analysis and Critical Control Points system is analyzed as a
student of the department of phi promising approach to integrated product quality
physical methods and instruments management, which could be used in the production of
for quality control of the Institute of medicines in parallel with the implementation of GMP rules.
Non-Destructive control
TPU.
Email: yanushevskaj@tpu.ru Keywords:
Region scientific interests: Quality, safety, quality management system, principles
integrated systems
of the HACCP system, risks, control points.
quality management, ser-
certification, quality of
pharmaceuticals, problems of Safe and high-quality medicines are one of the
QMS implementation in components of the quality of life of the population of any
organizations. country. In the last decade, the world has been realizing
the importance of ensuring the safety of medicines. One
of the main functions of the Federal Service for
Surveillance in the Sphere of Healthcare is the
organization of the examination of the quality, efficacy
and safety of medicines in accordance with
in accordance with the Administrative Regulation No. 734 of October 30, 2006, approved by order of
the Ministry of Health and Social Development [1].
The concepts of "quality" and "safety" should become the motto of the
pharmaceutical industry. In a market economy, the successful sale of pharmaceutical
products largely depends on the trust of customers and buyers in manufacturing
organizations. The dynamic development of the pharmaceutical market and increased
competition impose new requirements on the organization of management of
pharmaceutical enterprises. Under these conditions, it is strategically important to
determine the main directions for increasing competitiveness based on the characteristics
of a particular drug production.
An analysis of the experience of successful development of pharmaceutical enterprises in the
leading countries of the world economy showed that the achievement of the set development goals in
management is ensured by the use of European quality management methods, the implementation and
certification of quality systems in accordance with international standards ISO 9000, GMP (English Good
manufactured practice - rules for organizing the production and quality control of medicines).

The variety of management systems and the standards used in their creation covers
various areas of activity: quality, ecology, occupational health and safety, social
responsibility, etc. Recently, the development of management systems is also taking into
account industry specifics, affecting such areas such as the safety of medicines, food, energy
supply, etc.

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Russian pharmaceutical enterprises and organizations are actively involved in the

implementation of quality management systems, where the main motive is to improve the
quality of enterprise management and ensure its effective development. However, the
experience gained in this way in the implementation of quality systems indicates that many
enterprises have not been able to achieve significant success in improving economic
performance. An analysis of the current situation shows that the main reason preventing
the achievement of high economic results through the creation of a quality system at an
enterprise is the lack of a reliable tool for assessing product quality [2].
The quality assurance system in the manufacture of medicines should guarantee:

- that the products are designed to meet all requirements and standards;
- all production and control operations are clearly documented in accordance with the
rules of the standard;
- responsibility and authority are strictly defined;
- arrangements are made for the production, supply and use of appropriate raw materials
and packaging materials;
- control of intermediate products and technological process, as well as validation;

- control and verification of finished products are carried out in accordance with the requirements of the
standard and legislation;
- a self-inspection and/or quality audit procedure is carried out, which regularly evaluates
the effectiveness and suitability of the quality assurance system.
The quality management system (QMS) is part of a unified quality assurance system
of an enterprise, which is aimed at achieving results in accordance with quality objectives to
meet the needs, expectations and requirements of consumers and other interested parties.
The various parts of an organization's management system can be integrated with the QMS
into a single management system using common elements. This makes it easier to plan,
allocate resources, set additional goals, and evaluate the overall performance of the
organization.

HACCP system

Currently, WHO (World Health Organization) experts are considering the HACCP
(Hazard Analysis and Critical Control Points) system as a promising approach to integrated
product quality management that could be used in the production of medicines in parallel
with the implementation of GMP rules.

Information on this system was discussed at the 36th Meeting of the WHO Expert Committee
on Specifications for Pharmaceutical Products (Geneva, Switzerland, May–June 1999). According to
experts, the concept of identifying critical stages of production processes and associated risks of
deterioration in product quality is consistent with the principles of the GMP system. The report of the
Committee contains a recommendation to continue the study and collection of information in this
area for possible application in the practice of pharmaceutical production. At the end of 2001, WHO
experts confirmed the previously expressed opinion about the similarity of approaches in the HACCP
and GMP systems in terms of identifying critical stages in the production of drugs in terms of product
quality and noted the expediency of using this approach in the production of drugs. The experts point
out that the application of the principles of the HACCP system can be the first step in the transition to
the GMP system. An opinion is expressed about the possibility of harmonizing the HACCP system with
the quality management system ISO 9001: 2000, now ISO 9001: 2008 [3].

HACCP is a product safety management system that provides control at absolutely all
stages of the food chain, at any point in the production process, as well as storage and sale
of products where there is a possibility of

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dangerous situation. In developed countries, each manufacturer develops its own HACCP
system, which takes into account all the technological features of production. The developed
system can be subject to changes, processed in order to comply with any changes in the
processes of production technologies.

Methodology of the HACCP system

HACCP methods cover:

- risk and hazard analysis;
- identification of potential product defects in relation to production facts; ram (critical
control points);
- warning (preventive) control, and not subsequent (reactive);
- responsibility and accountability.
The HACCP system is not a no-risk system. It is designed to reduce the risks posed
by potential food safety issues.
This system is an effective management tool that is used
is used to protect the enterprise (trademark) when promoting food products on the market
and protecting production processes from biological (microbiological), chemical, physical
and other risks of contamination.
The HACCP system was originally developed to deal with safety risks.
of food products through a systematic study of each stage of the production process, from
raw materials to the end consumer.
Currently, HACCP is the main model for managing and regulating the quality of food
products, the main tool for ensuring its safety. Particular attention is paid to the so-called
critical control points, where all existing types of risks associated with the consumption of
food, as a result of targeted control measures, can be prudently prevented, removed and
reduced to a reasonably acceptable level.

HACCP itself is not a system. However, if there is a good basic production practice
(GMP, etc.) and elements of system management, the application of the HACCP method
allows you to build a complete control system focused on preventing the appearance of
hazardous and potentially hazardous products.

Principles of the HACCP system

There are seven principles that formed the basis of the HACCP system and are applied
without fail when creating a system for a particular manufacturer: 1. Conducting an analysis of
hazardous factors (risks) through the process of assessing the significance of risks and their level
of danger at all stages of the product life cycle.
2. Definition of critical control points.
3. Setting critical limits for each critical control point (CCP) - defining a criterion that shows
that the process is under control.
4. Development of a monitoring system to ensure control of the CPC based on planned
measures or observations.
5. Determination of corrective actions to be taken when monitoring results indicate a lack of
control at a particular critical control point.

6. Development of a verification procedure to confirm the effectiveness of the HACCP

system.
7. Documentation of all procedures and records consistent with HACCP principles and their
application.
Conducting a thorough analysis of risks (hazards) is carried out through the process of
assessing the significance of potentially hazardous factors at all stages of the life cycle

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products controlled by the manufacturer. The likelihood of any risks is also assessed and
general preventive measures are developed to prevent, eliminate and minimize identified
hazards.
Definition of critical control points, as well as technological steps and procedures,
within which strict control makes it possible to prevent, prevent potential danger or, with
the help of certain measures, reduce the possibility of risks to zero.

Establish critical limits for each control point. Criteria are defined here to show that
the process is under control. Tolerances and limits are formed by the system developers,
which are extremely necessary to comply with so that the situation does not get out of
control at critical control points.
Establish procedures for monitoring critical control points. For this, surveillance
systems are installed at the CPC and various inspections are established through regular
analysis, testing and other types of production supervision.
Development of corrective actions to be taken in those cases
yah, when the inspection and observations indicate that the situation may go out of control
or is already out of control.
Establishing accounting procedures and maintaining documentation, in which the necessary
parameters are recorded. The documentation will be clear evidence that the production processes at
CPC are under control, all deviations that have arisen are being corrected, and the developed HACCP
system for this company is functioning effectively as a whole.
Establishment of procedures for checking a set of documentation, which must be
constantly maintained in working condition, reflecting all activities for the implementation,
execution and compliance with all HACCP principles. In other words, this set of documents
will reflect the fact that the developed HACCP system is viable for a given manufacturer.

Abroad, the principles and methodology of HACCP have been used for a long time. In
the UK, the Food Safety Act 1998 and the Food Hygiene Codes of Practice are included in the
HACCP.
Canada developed a Food Safety Enhancement Program (FSEP), 2001, to encourage
the establishment of HACCP-based procedures in all registered companies that are active in
the agriculture and food processing sectors.

The Australian Quarantine and Inspection Service (AQIS) has developed a new
control system known as the Food Hazard Control System (FHCS).

In the United States in 2002, the Food and Drug Administration's Food and Nutrition
Advisor recommended that the US Food and Drug Administration (FDA) encourage and
eventually introduce the use of HACCP throughout the food industry.

In the European Union, Council Directive 93/43/EEC of 14 June 1993 on food hygiene
requires food companies to develop systems based on HACCP in order to ensure food
safety. This Directive further proposes that Member States develop rules of practice for
specific areas of the food industry and adopt EN 29000 (the European equivalent of the ISO
9000 series) to introduce general rules of hygiene and also to develop guidelines for the
practice of good hygiene.

The decision of the European Commission of May 20, 1994 (94/35/EC3) requires a
system of own checks for the production and sale of products in the EU countries. This
Decision also applies to imports. “In-house verification” is the term used for all activities
aimed at ensuring and demonstrating that a product complies with the requirements of the
aforementioned Decision. The self-verification measures included in the Solution contain
HACCP requirements. The European Union has also decided that HACCP plans prepared by
manufacturers or exporters should be verified by a government agency.

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endowment administration appointed by the EU. For example, in India, the EU has
appointed an Export Inspection Board, under the jurisdiction of the Ministry of Commerce,
to review the HACCP plans of exporting companies. Voluntary third party HACCP
certification exists in several European countries, as well as in Australia, New Zealand and
India. The system has also begun to be applied in some countries of Latin America, the
Middle East and South Asia.
Today it can be predicted that in the next year the interest in the HACCP system
among Russian and Ukrainian specialists will increase. This is due to a number of legislative
initiatives. In Ukraine, for example, they are preparing to consider amendments to the Law
“On the Quality and Safety of Food Products and Food Raw Materials”. All enterprises whose
activities are related to food will be forced to introduce a system based on the principles of
HACCP.
In Russia, the HACCP system has been introduced since 2001, when Gosstandart registered the voluntary
certification system. One of the main motivations for Russian companies to implement HACCP was pressure from
partners and larger companies. However, with the country's accession to the WTO, the situation has changed
dramatically. Russia is increasingly integrating into the world economy, and the functioning of the HACCP quality system
is strictly mandatory for all WTO member states. And domestic enterprises seeking to enter foreign markets are
increasingly faced with the fact that they are required to implement this system at the enterprise. As a matter of fact, the
products of the majority of Russian companies after the country's accession to the WTO may turn out to be non-
competitive due to non-compliance with international requirements. According to statistics for 2012, about 80
enterprises in Russia have implemented the HACCP system, among them such enterprises as the AKKOND confectionery
factory (Cheboksary), the Lyubimiy Krai confectionery association (Otradnoye, Leningrad Region ), Samara Confectioner
Company (Samara), VKK Don (Voronezh). One of the obligatory requirements when concluding cooperation agreements
with such large network companies as Metro, Real, today is the presence of implemented product security systems at
manufacturing companies. Samara), VKK "Don" (Voronezh). One of the obligatory requirements when concluding
cooperation agreements with such large network companies as Metro, Real, today is the presence of implemented
product security systems at manufacturing companies. Samara), VKK "Don" (Voronezh). One of the obligatory
requirements when concluding cooperation agreements with such large network companies as Metro, Real, today is the
presence of implemented product security systems at manufacturing companies.
According to expert estimates, so far only 25% of domestic enterprises will be able to
compete in the domestic market with foreign manufacturers, especially when some customs
duties are significantly reduced [4]. Russia, as a member of the WTO, will also have to
implement the HACCP system. In addition, from July 1, 2013, the technical regulation “On
Food Safety” came into force, one of the articles of which states that in the implementation
of production processes, the manufacturer must develop, implement and maintain
procedures based on the principles of HACCP.

BIBLIOGRAPHY

1. Administrative regulations of the Federal Service for Supervision of Health and Social
Development for the performance of the state function of organizing the examination of
the quality, efficacy and safety of medicines. Approved by order of the Ministry of Health
and Social Development No. 734 dated October 30, 2006. URL: http://www.referent.ru/
1/100234 (accessed 05/25/2013)
2. Weekly PHARMACY / Specialized medical online publication for doctors, pharmacists. URL:
http://www.apteka.ua (accessed 06/10/2013)
3. Ershova E.V., Breskina T.N., Goncharov N.G., Avetisyan A.Ya. Integrated management systems
in health care. Approaches to implementation at a pharmaceutical enterprise // Bulletin of
Roszdravnadzor. - No. 4. - 2012. - P. 34–38.
4. Ostretsov V.N., Gnezdilova A.I., Barashkova O.V. The introduction of a quality system is the
basis for the sustainability of processing enterprises // Economic and social changes:
facts, trends, forecast. - No. 3. - 2012. - S. 21–26.

Received 02.10.2013

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