Quality management systems in

biomedical engineering and

biopharmacy
Topic #1
" Review trends and prospects for the development of
quality management in Ukraine and the world »
Lecture #1
Lecture plan
1. What is quality?
2. Overview of trends and prospects for the development of quality
management in Ukraine and the world.
3. Economic and political reasons for increasing requirements for
product quality.
4. Evolution of quality and quality management systems: from control
to provision, management and integrated quality management.
 What is quality?
Currently, the word "quality" occupies one of the
first places in terms of frequency of use in
publications devoted to production processes. And
this is quite logical , since there is no more urgent
task than ensuring high quality of products.

Throughout the entire history of the development of

philosophy, attempts to find a comprehensive
definition of the concept of "quality" did not stop.
But all of them came down to the understanding of
quality as the certainty, commonality and integrity
of all essential features of the subject, which give it
relative stability and distinguish it from other
subjects.
 What is quality?
History shows that the defining prerequisite for the existence of human
society, which is based on labor activity, is the creation of material, social
and spiritual goods to satisfy personal and social needs. In the second half
of the 20th century, such a definition was formed and became widespread,
according to which the quality of a product began to be understood as its
property ( ability) to satisfy the needs and expectations of a specific
consumer.
Quality is a set of essential signs, properties, features that
distinguish an object or phenomenon from others and give it
definiteness; quality - one or another property, a sign that determines
the dignity of something.
In everyday life, the term "quality" is used in different senses . The quality
of the object (products, services) often refers to their special properties. At
the same time, the quality does not depend on how high the requirements
were
 To achieve a certain level of quality, scientific substantiation and precise
definition of the requirements for the object are important.

often understood as a class (level of requirements) that can be set for products,
for example, a higher grade (category), 1 grade (category), etc. This is incorrect. If the
product meets certain, albeit limited , requirements, it will be of high quality.

The establishment of requirements and their evaluation from the standpoint of

product quality are possible if the object has certain distinguishing features of quality
and is evaluated according to these features. For example, a student dormitory has its
own signs of quality, a working dormitory has its own, and a hotel has its own.
Quality is achieved if the requirements are satisfied through the properties of
the object, and regardless of whether these requirements are high or low.
Thus , quality is the degree of satisfaction of requirements due to product
properties .

According to the definition of the International Organization for

Standardization (ISO), quality is a set of properties and
characteristics of a product that give it the ability to satisfy specified
or anticipated needs.
 To determine the quality, the following steps must be
taken:
- establish needs;
- determine the real characteristics of products;
- compare these characteristics with the required ones.

These three components of quality definition are complex independent tasks in

themselves.

When establishing needs, distinguish between:

– established needs (this is typical for state procurement);
- anticipated needs (this is characteristic of the market).

An analysis of the needs that exist for any product has shown that they have the
following features:
- have a complex nature;
– change over time;
- can be public, collective, individual.
From these features comes the need, first, for a constant, purposeful and qualified
study of needs, secondly, the formulation of two groups of needs: quantitative and
qualitative, and thirdly, always a clear definition of the social level of needs (that is, for
whom).
 The quality of a biomedical product is a set of properties
that give a biomedical product (BP) the ability to satisfy the needs
of consumers in accordance with its purpose and meet the
requirements established by legislation. That is, the concept of
quality has both a subjective (“meet the needs of consumers”)
and an objective (“meet the requirements established by law”)
components.
Software quality medicines is widespread _ _ the concept
that includes a set of measures that affect the quality of the
finished product and guarantee conformity him requirements
regulatory documentation . From pharmaceutical positions -
guarantee conformity quality medical means their destination _
Quality loop with multistep functionality
 Overview of trends and prospects for the
development of quality management in Ukraine
and the world.

Western approach (USA, EUROPE) Eastern approach (JAPAN)

Quality is based on low prices Quality is based on minor defects

The first goal is profit, The first goal is quality,

quality - category is random Profit will come immediately
Agreement with the buyer's
Buyers must obtain the supplier's
requirements regarding quality
consent for quality issues
requirements

General ideas about quality Strict quality policy for each product
 Features of the Japanese quality management system

Generalized
Generalizedquality
qualitymanagement
managementatatthe
thecompany
companylevel,
level,participation
participation
ofofall employees
all employees

Training
Trainingand
andadvanced
advancedtraining
trainingofofpersonnel
personnelininthe
thefield
fieldofofquality
quality
management
management

Activities
Activitiesofofquality
qualitycircles
circles

Inspection
Inspectionand
andevaluation
evaluationofofquality
qualitymanagement
managementactivities
activities

Use
Useofofstatistical
statisticalmethods
methods

Nationwide
Nationwidequality
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 USA

The idea of integrated quality management is a system of measures

to develop, maintain and improve the quality of developed and
manufactured products

Four stages of quality management:

1. Establishing quality requirements
2. Assessment of compliance of products with these
requirements
3. Measures in case of non-compliance with these
requirements
4. Further increase of quality requirements
In the USA, comprehensive product quality control has been
implemented - quality control at all stages of the product life
cycle, which is not only verifiable, but also analytical in nature.
This is an organizational form of distribution of rights and
responsibilities between units and personnel related to quality
assurance
 Economic and political reasons for
increasing requirements for product quality.

The economic growth of many countries in modern conditions

is due to the introduction of a new management style aimed at
improving the quality of work and management using quality
management systems (QMS), for which international (ISO) and
national (DSTU ISO) standards have been developed.
 Factors affecting quality can be divided into:
- production (raw materials, tools, technologies, production infrastructure);
- human (professional skills and knowledge, organization and discipline of
employees, traditions, help and support of the team);
- economic (effective systems of material and moral stimulation,
determination of optimal cost).

Factors affecting the quality of products can also be divided into

objective (technical level of production, equipment, organizational
preparation of production, level of technology, etc.) and
subjective (personal interest in work results, level of education,
professional skills of employees, etc.).

These factors operate in certain conditions of economic activity of the

enterprise (firm). These include forms of labor organization, production
processes, team microclimate, etc. To achieve the optimal level of quality, one
should achieve the most acceptable ratio between factors and conditions
affecting quality.
 Factors that can change the properties and indicators of products can be
grouped into four groups:
- items of work,
- means of labor,
- labor process
- regulatory and technical documentation.

Regulatory and technical documentation is projects, working drawings,

methods, instructions, standards , etc.

The objects of labor are raw materials, materials, semi-finished products ,

Means of labor are buildings, constructions, equipment, tools, means of
communication ,
work process is connected with the organizational structure and
management organization of the enterprise as a whole. The labor process is
determined by the forms of production and labor organization, structure,
marketing, production conditions, functional activity, pricing planning, economic
stimulation , etc.
It should be noted that regulatory and technical documentation is the starting
point for the production of quality products, labor tools are the base, and the
human factor in the work process is the foundation.
Evolution of quality and quality management
systems: from control to assurance,
management and integrated quality
management.
The history of quality began with the emergence of the production of
goods and services, and developed along with the development of
production processes. Over time, the attitude to product quality changed,
but at all times, quality was the object of increased attention.
In the Middle Ages, craftsmen's workshops were combined into
workshops, products were made according to a certain pattern, from good
raw materials. The process of manufacturing the product was in the vision
of the master, he and the workers were responsible for the results of their
work. At the same time, the quality of the products gave artisans a reason
to feel satisfied with their work.
In any country, various measures of punishment were provided for
the manufacture of low-quality products, they came down to one thing -
the application of severe punishment to the guilty party for dishonest
work .
 Management activity gradually improved, but it was formed as an independent
scientific direction only in the 19th century.
It is believed that the beginning of quality management as a science was laid in
1886 by the American engineer Frederick Taylor, who is now called the " father of
scientific management ". The principles developed by him at the beginning of the
20th century have been preserved until now. F. Taylor considered the best
management method to be the unity of the following principles:
- development of scientific bases of production;
- scientific selection of workers;
- scientific education and training of workers;
- close and friendly cooperation between the administration and workers.

At the initial stage, quality management represented separate elements that

were part of production management and was considered as an engineering and
technical problem of product control.

In the future, quality management was separated into an independent direction.

 In the history of the development of product quality
management in the twentieth century, it is customary to
distinguish several stages, with the duration of each of them
- twenty years, which received the following conventional
names:
 mechanical control (before 1900);
 control of the master (1900-1920);
 inspection control (1920-1940);
 statistical control (1940-1960);
 quality assurance (1960-1980);
 general quality management (1980-2000 ).
 At the first stage, each worker himself was responsible for the products of his own
production, made with the help of manual or machine labor.

 The second stage tentatively belongs to the period from 1900 to 1920. Its essence
was that the main responsibility for quality rested with the master (the master).
During this period, upper and lower quality limits, tolerance fields, and various
measuring tools (templates and gauges) are introduced. Different methods of
stimulating the production of quality products were developed and applied, as well
as a system of fines for defects, the need to introduce an independent position of
quality inspector was substantiated. At this stage, product quality was defined as
compliance with standards .
 The third stage of the evolution of quality management covered the period from 1920
to 1940. At this time, quality inspections based on F. Taylor began to appear. 100%
inspection of finished products began.
Quality control was transferred to the hands of specially trained independent quality
inspectors . For the first time, methods of statistical control of the production process were
used: control charts, the need for selective methods of product quality control was
substantiated. Walter's works played a major role in the introduction of statistical methods
into production management Shuhart (1891-1967). He introduced control charts into practice,
laid the foundations of the modern philosophy of quality.
At this stage, quality was defined as compliance with standards and process
stability . Control of finished products was carried out .

The fourth stage , from 1940 to 1960, received the conventional name "Statistical
quality control", because it was at this time that statistical methods of quality control were
widely distributed . Despite the fact that statistical methods were developed in the United
States, they did not receive much recognition there, but began to be actively used in
Japanese enterprises. The problem of quality in Japan became a nationwide national
program, and with the direct participation of Kaoru Ishikawa , statistical methods began to be
studied at school. At enterprises, they were studied in quality circles.
At this stage, the quality of products, production processes, activities in the service
sector was defined as compliance with market requirements . Design and production
control was carried out .
 The fifth stage covered the period from 1960 to 1980. At this stage, Edwards made a
great contribution to the development of the theory and practice of quality management
Deming and Joseph Juran . They assigned a special role in ensuring product quality to the
top management of the company. The philosophy of quality and methods of ensuring it,
developed by these scientists, later formed the basis of the theory of Total Quality
Management (TQM) .
During this period, the idea of integrated quality management was developed ,
which provided for the accounting of all factors affecting quality, that is, quality
management was carried out at all stages of production and between all divisions of
the company . The concept of " quality assurance systems" was developed and
spread , which ensured not only the design and manufacture of quality products, but
also the quality of all the company's activities.
At this stage, quality was defined as meeting the requirements and needs of
customers and employees. All activities of the producer were monitored .
At the sixth stage - the end of the twentieth century, there is a wide spread of TQM
principles . The TQM system is a comprehensive system of the organization's internal
activities, aimed at meeting the quality requirements of consumers, at constant quality
improvement, at minimizing production costs and timely delivery.
Thus, at this and the current stage, quality is defined as meeting the requirements
and needs of customers. Management of the quality of the enterprise and management of
the quality of society as a whole is carried out.
 Quality of biopharmaceutical products.

Biopharmaceutical products include :

- medicinal products of biological and biotechnological origin;
- medical immunobiological preparations (drugs);
- medical products of biological and biotechnological origin;
- food products for special dietary consumption (dietary supplements, functional
food products, etc.) of biological and biotechnological origin
- cosmetic products.

Therefore, all groups of biopharmaceutical products concern human health,

that is why quality is not only a goal in the biopharmaceutical industry, but also a
means of preserving and improving the level of health of citizens .
 Criteria quality
efficiency;
safety of use;
a significant advantage over well-known drugs that are similar in effect and
are already used in medical practice (for new drugs);
identification and quantitative content of ingredients;
absence of impurities (degree of purity);
activity and stability of the chemical composition;
stability during storage;
justified value (price).
Quality control is that part _ systems management quality , which is
connected with sampling , specifications and conduct trials as well with
organization and documentation procedures and issues permission to
issue which _ guarantee that _ really conducted all necessary and
corresponding trial and what there will be no materials allowed for use ,
and the products will not be allowed for sale or supply as long as their
quality will not be recognized satisfactory _
 The main ones quality control
requirements :
1. Availability proper means for control .
2. Qualified staff on which laid function implementation of quality control .
3. Approved methods for sampling , control and trial outgoing raw materials , packaging
materials , intermediate , unpackaged and ready products .
4. Control of factors surrounding environments which _ able influence the results tests (if
necessary ).
5. Methods trial must pass validation .
6. Must be composed protocols that document that _ _ _ all necessary measures regarding
sampling , control and test methods really conducted _ Protocols drawn up based on the
results of controls and tests materials , intermediate , unpackaged and ready products
must be official _ matched with the requirements specifications .
7. Must be composed protocols that document that _ _ _ all necessary measures regarding
sampling , control and test methods really conducted _ Protocols drawn up based on the
results of controls and tests materials , intermediate , unpackaged and ready products
must be official _ matched with the requirements specifications .
7. Audit ready products for compliance registration dossier ( active
auxiliary ingredients _ substances , required cleanliness, containers
(packaging), labeling ).
8. None series ready products may not be authorized for sale or
delivery before the authorized person certifies her conformity
requirements registration dossiers and production licenses . _
9. It is necessary to store a sufficient number of control samples of raw
materials and preparations, which allows testing of products during
storage (if necessary); the drug should be stored in the final
package, except for exceptionally large packages.
 The quality of pharmaceuticals is achieved through strict
compliance principles software quality from development before
production and afterwards supported on the network distribution
using _ means quality control systems .
Not enough only formally perform everyone specified species
activities ; their necessary carry out effectively based on criteria _ safety ,
efficiency and indicators quality medicines _
Quality is a totality features and characteristics of products or services
which _ are doing possible satisfy existing or anticipated needs (ISO
8402).
Quality medicinal tool - aggregate properties which _ provide medical
tool ability satisfy consumers according to his appointment and
correspond requirements established _ legislation (the Law of Ukraine
"On Medical means ", 1996).
Quality medicinal tool - fitness for purpose use and compliance to all
requirements national registration , as well as their ability cause
provided therapeutic or preventive effect after application the same
dosage forms (tablets, capsules, ampoules, etc. ).
The main ones properties (characteristics) of the medicinal
product tools are:

1. efficiency medicinal means - consists in high preventive and

therapeutic indicators and in satisfaction pressing medical needs ;
2. safety medicinal means - this degree side phenomena ( functional
disorders , immune reactivity , teratogenic action and reproductive
capacity , narcotic action etc. ), their frequency, ratio benefit / risk
when using of this drug compared to analogue drugs;
3. advantages over analogue drugs, which already used in treatment
practice - requires conducting a complex comparison between I use
and risk caused by application comparative drugs that _ is based on
the following principles:
4. identity and quantitative content of ingredients, absence of
impurities, activity and stability of the chemical composition of the
medicinal product, stability during storage;
5. variety of medicinal forms and doses;
6. frequency of reception;
7. speed of onset and duration of action;
8. activity concerning:
 number of nosologies (one, two or more);
 the course of the disease (acute, subacute , chronic);
 the severity of the disease (mild, medium, severe);
 of different age groups (children, adults, the elderly);
8. ease of use;
9. novelty - an original drug of a new pharmacological group, an
original drug of an existing pharmacological group, a generic drug .
10. packaging design.
The quality of the medical product
The quality of the medical product - a set of properties of a medical
product that reflect the safety, durability, reliability of the medical
product, etc. and give it the ability to satisfy the consumer and/or user
in accordance with its purpose during the declared period of its
effective operation.
The properties of the medical product are:

efficiency;
reliability;
functionality;
durability;
maintainability;
economy;
design;
ease of use, etc.
The effectiveness of a medical product is a set of characteristics of a
medical product that ensure the achievement of prophylactic,
diagnostic, therapeutic and/or other expected positive effect when it is
used as intended.
 Thank you
for attention !