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22 Φεβ 2013 (πριν από 4 χρόνια και 7 μήνες)

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Проект 511092
-
1
-
Tempus
-
2010
-
1
-
UK
-
JPCR

«Улучшение учебных программ Биотехнология (фармацевтический инжениринг)»

Enhancement of biotechnology
(Pharmaceutical engineering) curriculum at
masters level in Russian
Universities


Analytical presentation (1)

User Needs Survey and
Analysis

Проект 511092
-
1
-
Tempus
-
2010
-
1
-
UK
-
JPCR

«Улучшение учебных программ Биотехнология (фармацевтический инжениринг)»

Work Package 1
-
2:

Activities leading to the clear definition of learning outcomes,
competences and learning
centred

curricula:

Establish and run Stakeholder working group to define learning
outcomes, competences and curricula.

Learning outcomes will be aligned to the relevant level descriptors
within the European Framework and a visit made to the ECTS
representative in Moscow to verify the approach leading to a clearly
defined list of learning outcomes and competences aligned with ECTS
requirements.

Curricula will be developed through expert assessment using matrix
instruments with the assessment of student input standards to
identify needs for additional training leading to the specification of
modes of study,
programme

structure, syllabus, student workload and
assessment
methods

The
proposed curricula will be discussed with stakeholders and coordinated
with ECTS and EU Tuning points to ensure compatibility leading to clearly
defined Curricula for the Masters
programme

aligned with ECTS
requirements.

Проект 511092
-
1
-
Tempus
-
2010
-
1
-
UK
-
JPCR

«Улучшение учебных программ Биотехнология (фармацевтический инжениринг)»

Biotechnology


a priority
in
EU and RF:




A
thematic area (along with health) in the EU’s Seventh
Framework
Programme

for Research and Technological
Development (2007
-
2013)



A top
priority in the Russian government’s “Concept of Long Term
Social and Economic Development till 2020”.



Tempus
IV National Priorities
-

curriculum
development in
biotechnology.



Russian government priority
-

the modernization
of
industry
paying
special attention to
producing safe
and accessible
pharmaceutical products for the Russian market.

Проект 511092
-
1
-
Tempus
-
2010
-
1
-
UK
-
JPCR

«Улучшение учебных программ Биотехнология (фармацевтический инжениринг)»

Shortage of trained personnel:


According
to
Zoya

Kozlova
, general director of the
Pharmaceutical Recruiting Agency “Generis” (Interview
October 2009) on average, there is a 30
-
50% shortfall of
production technologists and an 80% shortfall of
laboratory technologists across the 5
-
600 pharmaceutical
producers in Russia.



Проект 511092
-
1
-
Tempus
-
2010
-
1
-
UK
-
JPCR

«Улучшение учебных программ Биотехнология (фармацевтический инжениринг)»


To overcome
personnel
shortage
;


To increase the
quality of
education
;


Training new
types of
specialists.

0
100
200
300
400
500
600
700
800
Кадровый заказ фармацевтической отрасли на период
2009
-
2011 годов (
I
этап Стратегии "Фарма
-
2020
"), чел.

2009
2010
2011
2012
Clinical
research
managers

Scientific

managers

Technologists

Effective
managers

Innovative
entrepreneurs

Personnel requirements for the pharmaceutical sector
2009
-
2012 (1
st

stage of strategy Pharm
-
2020)

Scientific


staff

Проект 511092
-
1
-
Tempus
-
2010
-
1
-
UK
-
JPCR

«Улучшение учебных программ Биотехнология (фармацевтический инжениринг)»

1830

1730

1250

410

327

200

100

400

650

750

600

500

500

500

500

500

0
200
400
600
800
1000
1200
1400
1600
1800
2000
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
Dynamic of changing demand for personnel
.

Стратегия
2020

ФЦП

Strategy 2020


Federal
programme


To train:


6
-
10000
production
specialists
;


4
-
9000 R&D
specialists.

Проект 511092
-
1
-
Tempus
-
2010
-
1
-
UK
-
JPCR

«Улучшение учебных программ Биотехнология (фармацевтический инжениринг)»

Innovative medicine training in the EU:





Several
EU Higher Education bodies have moved in this
direction by offering
progammes

in Bioscience,
Biotechnology or Pharmaceutical engineering, which
offer not purely the scientific disciplines such as the
basics of chemistry, physics, biology and microbiology
but also provide a sound knowledge of
biopharmaceutical manufacturing, bioreactor design,
process control and processing, metabolic engineering
as well as the key regulatory aspects and a risk based
approach to safety, quality and efficacy.



Проект 511092
-
1
-
Tempus
-
2010
-
1
-
UK
-
JPCR

«Улучшение учебных программ Биотехнология (фармацевтический инжениринг)»



1900

1925

1950


1975

2000

2025
Реактивное регулирование



















регулирование основанное на науке
Стандартизация
-

испытание
Контроль качества
и безопасности
Инспекция
производства
Обеспечение
качества

-
Систематизация

и
сертификация

Всеобщее управление

качеством

-
Управление
процессами и СПС
Менеджмент качества

-

стратегия
,
менеджмент
риска
,
управление
знанием и пониманием о
продукции
,
процессах
}
Система
фармацевтического
качества

в т
.
ч
.
ICH
8
,
9

&
10
1963

1
-
й

GMP

19
79

1
-
й

GLP

1987

1
-
й

ISO
9000

2004
-
6

ICH

8,9

&
10
Проект 511092
-
1
-
Tempus
-
2010
-
1
-
UK
-
JPCR

«Улучшение учебных программ Биотехнология (фармацевтический инжениринг)»

Ответственность
менеджмента
Обеспечение
качества
GMP
Контроль
качества
100%
90%
80%
Производство
Передача
технологии
Разработка л
\
с
Снятие л
\
с из
производства
Дистрибюция
Жизненный цикл
Управление
знанием
Управление
персоналом
ИТ
Система
документации
Вспомогательные процессы
Коррективные и
превентивные меры
,
управление
изменениями
Результаты
процессов и
качество продукта
Процесс улучшения
Анализ
руководством
Менеджмент
риска
СИСТЕМА

ФАРМАЦЕВТИЧЕСКОГО

КАЧЕСТВА
Маркетинг
Регистрация Лицензирование
Проект 511092
-
1
-
Tempus
-
2010
-
1
-
UK
-
JPCR

«Улучшение учебных программ Биотехнология (фармацевтический инжениринг)»

Regulatory environment:


International:


WHO, FDA, European Directives and national systems


Harmonised

structures through the life cycle through


such
organisations

as PIC/S, EMA, EDQM


Russian:


Ministries of Health, Education, Industry


RosZdravNadzor


Проект 511092
-
1
-
Tempus
-
2010
-
1
-
UK
-
JPCR

«Улучшение учебных программ Биотехнология (фармацевтический инжениринг)»

Key personnel

(as defined by European Directive):



Qualified Person (often linked to Quality manager)


Head of Production


Head of Quality Control



Проект 511092
-
1
-
Tempus
-
2010
-
1
-
UK
-
JPCR

«Улучшение учебных программ Биотехнология (фармацевтический инжениринг)»

Other important personnel:



Pharmaceutical development specialists


Process development engineers


Process managers


Transfer technologists


Quality assurance (GMP) specialists


Validation personnel


Computer validation engineers


Technical support personnel


IT specialists


Supply chain managers


GMP inspectors/auditors


Regulatory managers




Проект 511092
-
1
-
Tempus
-
2010
-
1
-
UK
-
JPCR

«Улучшение учебных программ Биотехнология (фармацевтический инжениринг)»

The EU Qualified Person (Directive 201/83):


A qualified person shall be in possession of a diploma,
certificate or formal qualifications (4 years).


Applied physics


General and inorganic chemistry


Organic chemistry


Analytical chemistry


Pharmaceutical chemistry


General and applied biochemistry (medical)


Physiology


Microbiology


Pharmacology


Pharmaceutical technology


Toxicology


Pharmacognosy

Проект 511092
-
1
-
Tempus
-
2010
-
1
-
UK
-
JPCR

«Улучшение учебных программ Биотехнология (фармацевтический инжениринг)»

The Qualified Person (QP Study Guide
-

UK):


The three foundation knowledge elements:

a Pharmaceutical law and administration

b The role and professional duties of a Qualified Person

c Quality management systems


Additional knowledge requirements for the Qualified Person:

d Mathematics and statistics

e Medicinal chemistry and therapeutics

f Pharmaceutical formulation and processing

g Pharmaceutical microbiology

h Analysis and testing

i

Pharmaceutical packaging

j Active pharmaceutical ingredients

k Investigational medicinal products

Проект 511092
-
1
-
Tempus
-
2010
-
1
-
UK
-
JPCR

«Улучшение учебных программ Биотехнология (фармацевтический инжениринг)»

ISPE
Programme



Process development specialists

Quality assurance and GMP specialists

Quality control personnel

Validation personnel

Manufacturing/production supervisors

Technical support personnel

IT personnel and validation specialists

Supply chain managers

Engineering professionals

Inspectors/Auditors

Regulatory managers

Fundamentals of biotechnology



x

x

x

x

x

x

x

x





Microbiology



x

x

x

x

x





x

x

x

Biopharmaceutical manufacturing processes

x

x



x

x







x



x

Sterile drug manufacturing

X

x

x

x

x







x



x

Engineering systems (HVAC, Water etc)



x

x

x

x

x





x



x

Project management



x





x

x

x



x





Cleaning fundamentals and validation



x

x



x

x





x





GMP fundamentals and application

x

x

x

x

x

x

x

x

x

x

x

Basic principles and risk based Commissioning and qualification



x













x





Principles and practice of computerized systems compliance



x

x

x

x

x

x









Auditing for GMP



x

x

x

x

x



x

x

x

x

Technology transfer for API and finished dosage forms

x

x



x

x







x



x

Implementing Process Analytical Technology

x

x



x

x







x



x

Practical approach to calibration
x

x



x



x

x









Concepts of validation, a risk based approach to process validation

x

x

x

x

x

x





x



x

Проект 511092
-
1
-
Tempus
-
2010
-
1
-
UK
-
JPCR

«Улучшение учебных программ Биотехнология (фармацевтический инжениринг)»

Results of industry survey:


Companies such as:

OOO “
Gerofarm
”, “
Stada
” CIS
Zio


Zdorovie


KRKA
Rus
, OAO “
Akhrikhin




Backed by meetings of


SPFO Work group,


ARFP Committee on Education and Training


Sub Committee of European Business
Association


Biotechnology forum


Проект 511092
-
1
-
Tempus
-
2010
-
1
-
UK
-
JPCR

«Улучшение учебных программ Биотехнология (фармацевтический инжениринг)»

0
5
10
15
20
25
30
35
Mathematics and statistics
Pharmacology
Applied physics
Toxicology
General and applied biochemistry
General chemistry
Physiology
Microbiology
Pharmaceutical chemistry
Pharmaceutical technology
Basic Science

Score
Проект 511092
-
1
-
Tempus
-
2010
-
1
-
UK
-
JPCR

«Улучшение учебных программ Биотехнология (фармацевтический инжениринг)»

0
5
10
15
20
25
30
35
Regulatory systems
Process life cycles
Managing supply chains
Pharmaceutical quality
Product development
Systems and equipment
Quality control
Science and technology
Applied technology

Score
Проект 511092
-
1
-
Tempus
-
2010
-
1
-
UK
-
JPCR

«Улучшение учебных программ Биотехнология (фармацевтический инжениринг)»

0
5
10
15
20
25
30
35
Change management
Managing time
Innovation
Presentation skills
Communications
Team work
Management skills


Score
Проект 511092
-
1
-
Tempus
-
2010
-
1
-
UK
-
JPCR

«Улучшение учебных программ Биотехнология (фармацевтический инжениринг)»

0
0.5
1
1.5
2
2.5
3
3.5
4
4.5
International
regulation
Registration and
licensing
Ethics
Audit and inspection
Safety, health and
environment
Risked based
analysis
Regulatory systems

Score
Проект 511092
-
1
-
Tempus
-
2010
-
1
-
UK
-
JPCR

«Улучшение учебных программ Биотехнология (фармацевтический инжениринг)»

0
0.5
1
1.5
2
2.5
3
3.5
4
4.5
5
Understanding costs
GCP/GLP
Knowledge management
Robust processes
Technology transfer
Quality by design
Development and formulation
Product development

Score
Проект 511092
-
1
-
Tempus
-
2010
-
1
-
UK
-
JPCR

«Улучшение учебных программ Биотехнология (фармацевтический инжениринг)»

0
0.5
1
1.5
2
2.5
3
3.5
4
4.5
Process mapping and automation
Managing resources
Personnel management
Process analysis and improvement
Managing change
Production technologies
Life cycle processes

Score
Проект 511092
-
1
-
Tempus
-
2010
-
1
-
UK
-
JPCR

«Улучшение учебных программ Биотехнология (фармацевтический инжениринг)»

0
0.5
1
1.5
2
2.5
3
3.5
4
4.5
ERP systems and logistics
Supply chain dynamics
Strategic planning
Managing suppliers
Supply change management

Score
Проект 511092
-
1
-
Tempus
-
2010
-
1
-
UK
-
JPCR

«Улучшение учебных программ Биотехнология (фармацевтический инжениринг)»

0
0.5
1
1.5
2
2.5
3
3.5
4
4.5
Information systems
Facility design
Managing projects
Support systems (Electricity, water, HVAC)
Reliability and effectiveness
Qualification and validation
Systems and Equipment

Score
Проект 511092
-
1
-
Tempus
-
2010
-
1
-
UK
-
JPCR

«Улучшение учебных программ Биотехнология (фармацевтический инжениринг)»

3.7
3.8
3.9
4
4.1
4.2
4.3
SPC
Process analysis technology (PAT)
Risk management
GMP and associated systems
Quality by testing and by design
Product life cycle
Pharmaceutical Quality System
Process validation
Pharmaceutical quality

Score
Проект 511092
-
1
-
Tempus
-
2010
-
1
-
UK
-
JPCR

«Улучшение учебных программ Биотехнология (фармацевтический инжениринг)»

0
0.5
1
1.5
2
2.5
3
3.5
4
Bioreator design
Types of processing
Particle science
Design of experiments
Materials and their use
Science and technology

Score
Проект 511092
-
1
-
Tempus
-
2010
-
1
-
UK
-
JPCR

«Улучшение учебных программ Биотехнология (фармацевтический инжениринг)»

4
4.05
4.1
4.15
4.2
4.25
4.3
Sterility, Efficacy, stability
Principles of quality control
Analytical methods and equipment
GLP
Cleaning and sanitation
Quality control

Score
Проект 511092
-
1
-
Tempus
-
2010
-
1
-
UK
-
JPCR

«Улучшение учебных программ Биотехнология (фармацевтический инжениринг)»

Student survey


4 departments 5
th

and 6
th

years.

Проект 511092
-
1
-
Tempus
-
2010
-
1
-
UK
-
JPCR

«Улучшение учебных программ Биотехнология (фармацевтический инжениринг)»

Basic science


0.0
0.5
1.0
1.5
2.0
2.5
3.0
3.5
4.0
4.5
Математика и статистика

Прикладная физика

Общая химия

Фармацевтическая химия

Общая и прикладная биохимия

Физиология

Микробиология

Фармокология

Фармацевтическая технология

Токсикология

КГМА

МИТХТ

СПХФА
-

ФФ

СПХФА
-
БТ

Проект 511092
-
1
-
Tempus
-
2010
-
1
-
UK
-
JPCR

«Улучшение учебных программ Биотехнология (фармацевтический инжениринг)»

Basic science


0.0
0.5
1.0
1.5
2.0
2.5
3.0
3.5
4.0
4.5
Математика и статистика

Прикладная физика

Общая химия

Фармацевтическая химия

Общая и прикладная биохимия

Физиология

Микробиология

Фармокология

Фармацевтическая технология

Токсикология

КГМА

МИТХТ

СПХФА
-

ФФ

СПХФА
-
БТ

Проект 511092
-
1
-
Tempus
-
2010
-
1
-
UK
-
JPCR

«Улучшение учебных программ Биотехнология (фармацевтический инжениринг)»

Basic science


0
0.5
1
1.5
2
2.5
3
3.5
4
Математика и статистика

Прикладная физика

Общая химия

Фармацевтическая химия

Общая и прикладная биохимия

Физиология

Микробиология

Фармокология

Фармацевтическая технология

Токсикология

Средный
-

2,9

Средный
-

2,9

Проект 511092
-
1
-
Tempus
-
2010
-
1
-
UK
-
JPCR

«Улучшение учебных программ Биотехнология (фармацевтический инжениринг)»

Applied science


0.0
0.5
1.0
1.5
2.0
2.5
3.0
3.5
4.0
Система регуляции

Разработка нового препарата

Фармацевтическое качество

Процессы жизненного цикла

Системы и оборудование

Управление цепочки поставщиков

Наука и технология

Контроль качества

КГМА

МИТХТ

СПХФА
-

ФФ

СПХФА
-
БТ

Проект 511092
-
1
-
Tempus
-
2010
-
1
-
UK
-
JPCR

«Улучшение учебных программ Биотехнология (фармацевтический инжениринг)»

Applied science


0
0.5
1
1.5
2
2.5
3
3.5
Система регуляции

Разработка нового препарата

Фармацевтическое качество

Процессы жизненного цикла

Системы и оборудование

Управление цепочки поставщиков

Наука и технология

Контроль качества

Средный
-

2,8

Средный
-

2,8

Проект 511092
-
1
-
Tempus
-
2010
-
1
-
UK
-
JPCR

«Улучшение учебных программ Биотехнология (фармацевтический инжениринг)»

Management skills


0.0
0.5
1.0
1.5
2.0
2.5
3.0
3.5
4.0
4.5
5.0
Командная работа

Менеджмент времени

Менеджмент изменений

Презентационные навыки

Коммуникация

Инновация

КГМА

МИТХТ

СПХФА
-

ФФ

СПХФА
-
БТ

Проект 511092
-
1
-
Tempus
-
2010
-
1
-
UK
-
JPCR

«Улучшение учебных программ Биотехнология (фармацевтический инжениринг)»

Management skills


0
0.5
1
1.5
2
2.5
3
3.5
4
Командная работа

Менеджмент времени

Менеджмент изменений

Презентационные навыки

Коммуникация

Инновация

Средный
-

3,3

Средный
-

3,3

Проект 511092
-
1
-
Tempus
-
2010
-
1
-
UK
-
JPCR

«Улучшение учебных программ Биотехнология (фармацевтический инжениринг)»

Comparison


basic science


0
0.5
1
1.5
2
2.5
3
3.5
4
Математика и статистика

Прикладная физика

Общая химия

Фармацевтическая химия

Общая и прикладная биохимия

Физиология

Микробиология

Фармокология

Фармацевтическая технология

Токсикология

Industry -2,9
Staff - 2,1
Students - 2,9
Проект 511092
-
1
-
Tempus
-
2010
-
1
-
UK
-
JPCR

«Улучшение учебных программ Биотехнология (фармацевтический инжениринг)»

Appendix 1

The EU Qualified Person (QP Study Guide
-

UK)
-

2:


The three foundation knowledge elements:

Pharmaceutical law and administration

A thorough understanding of:

• European pharmaceutical directives (including but not limited to 2001/83/EC, 2001/82/EC,

2001/20/EC, 2003/94/EC, 2004/24/EC, 2004/27/EC, 2004/28/EC);

• the UK Medicines Act (1968) and other UK national medicines legislation, and the
Veterinary Medicines Regulation, including amendments;

• Marketing, Manufacturing and Wholesaler
Authorisation

requirements and

responsibilities;

• the role, legal status and structure of both the European and British Pharmacopoeias,

including the Certification procedure of the EDQM;

• the
organisation

of the UK MHRA, the role of the European Agency for the Evaluation of
Medicinal Products (EMEA), and the role of the Veterinary Medicines Directorate (VMD);

• procedures for dealing with complaints and product recalls and the role of the MHRA’s
Defective Medicines Reporting Centre, CHMP and CVMP guidelines on quality;

• The International Conference on
Harmonisation

(ICH and VICH) guidelines;

• Mutual Recognition Agreements (MRAs);

• Pharmaceutical Inspection Co
-
operation Scheme (PICS);


Проект 511092
-
1
-
Tempus
-
2010
-
1
-
UK
-
JPCR

«Улучшение учебных программ Биотехнология (фармацевтический инжениринг)»

The EU Qualified Person (QP Study Guide
-

UK)
-

3:


The three foundation knowledge elements:

The role and professional duties of a Qualified Person

A thorough understanding of:


batch review and decision making on disposition.


• the principles and practice of current GMP and QA as given in European Directives
and Guides on


Good Manufacturing Practice including relevant Regulations made under the
Medicines Act 1968 and


the current edition of the MHRA’s Rules and Guidance for Pharmaceutical
Manufacturers and


Distributors, ("the Orange Guide");


• the conduct and obligations of MA and MAA holders;


• the preparation for and management of Regulatory Inspections.


Проект 511092
-
1
-
Tempus
-
2010
-
1
-
UK
-
JPCR

«Улучшение учебных программ Биотехнология (фармацевтический инжениринг)»

The EU Qualified Person (QP Study Guide
-

UK)
-

4:


The three foundation knowledge elements:

Quality management systems


A thorough understanding of:



the philosophy and basic principles of QA;

• the design criteria for an effective QMS;

• auditing and self inspections;

• deviations and change control;

• documentation and record keeping;

• the interpersonal skills (leadership, delegation, communication, etc) necessary to implement an
effective QMS;

• the concepts associated with risk management;

• the principles of design, selection, qualification and maintenance of premises, equipment,
utilities, and services;

• calibration, preventative maintenance and training;

• the principles of purchasing and supplier certification, including knowledge of supply chains and
material control and the roles of brokers, distributors and
repackagers
;

• production planning, scheduling, and inventory control;

• annual product quality reviews;

• the interface between QA and the Development, Regulatory Affairs, and Marketing Departments;

• the skills and competences needed to provide effective Good Pharmaceutical Manufacturing
Practice training;


organisational

structures and reporting relationships;

• technical agreements and auditing in contract giving and acceptance.

Проект 511092
-
1
-
Tempus
-
2010
-
1
-
UK
-
JPCR

«Улучшение учебных программ Биотехнология (фармацевтический инжениринг)»

The EU Qualified Person (QP Study Guide
-

UK)


5


Mathematics and statistics

The practical application of basic statistical tools in pharmaceutical production and QA is
essential in demonstrating the capability of processes or the acceptability of materials.

Applicants will be expected to demonstrate an understanding of the following:

• Statistical Process Control;

• BS6000
-
6001 (Sampling plans);

• Process Control Charts;

• Acceptable Quality Levels (AQLs) (subset of 6001/2);

• statistics applied during analytical method validation.

Проект 511092
-
1
-
Tempus
-
2010
-
1
-
UK
-
JPCR

«Улучшение учебных программ Биотехнология (фармацевтический инжениринг)»

The EU Qualified Person (QP Study Guide
-

UK)


6:


Medicinal chemistry and therapeutics

The Qualified Person must have an understanding of the actions and uses of medicines in
clinical practice in order to judge their significance for the manufacture of sales material or
clinical trial supplies. Evaluating the significance of cross
-
contamination hazards or product
complaints are examples where such knowledge is important.

Applicants will be expected to demonstrate an understanding of the following:

• basic physiology;

• outline knowledge of the autonomic nervous system and some general aspects of chemical

structure/pharmacological action relationships;

• summary of key therapeutic drug classifications with examples;

• examples of disease states and their treatment with medicinal products;

• general absorption, distribution, metabolism and excretion of drugs;

• principal routes of drug administration;

• role of the company medical department;


pharmacovigilance

related to quality monitoring;

• general implications of clinical knowledge of drugs upon facility design, plant
segregation/isolation, cleaning verification and production scheduling.

Проект 511092
-
1
-
Tempus
-
2010
-
1
-
UK
-
JPCR

«Улучшение учебных программ Биотехнология (фармацевтический инжениринг)»

The EU Qualified Person (QP Study Guide
-

UK)


7:


Pharmaceutical formulation and processing

The formulation and processing conditions employed in the manufacture of medicinal
products have a significant effect upon their safety, quality and efficacy. Even subtle changes
to the input materials and/or processing conditions can have a profound adverse effect on
content uniformity, stability, bioavailability, and other attributes which are not detectable by
routine QC testing.

It is vitally important that the Qualified Person understands the principles of formulation and
pharmaceutical processing to ensure that informed release decisions are made.

Applicants will be expected to demonstrate an understanding of the following:

• the major processing techniques, their limitations and critical control parameters;

• the factors that could potentially affect content uniformity, stability (chemical, physical and

microbiological) and bioavailability in manufacture;

• the principles of process validation and control;

• the principles of technology transfer and production scale
-
up;

• pre
-
formulation studies and product development;

• the storage and distribution of materials and finished products.

Проект 511092
-
1
-
Tempus
-
2010
-
1
-
UK
-
JPCR

«Улучшение учебных программ Биотехнология (фармацевтический инжениринг)»

The EU Qualified Person (QP Study Guide
-

UK)


7:


Pharmaceutical microbiology

The Qualified Person must understand the significance of the presence of bacteria, yeasts,
moulds, viruses and toxins in pharmaceutical raw materials, products and production
environments. In addition, they must understand how to prevent contamination by good
product design, GMP and control over starting materials, intermediates, finished products,
production plant and processes, people and the environment.

Applicants will be expected to demonstrate an understanding of the following:

• sources and types of micro
-
organisms as related to pharmaceutical production;

• production of sterile and non
-
sterile products and associated environmental controls;

• bacterial
endotoxins

and
pyrogens
, their sources, removal and testing;

• microbiology of water, its production and distribution systems;


sterilisation

and disinfection methods;

• interpretation of microbiological data;

• validation of microbiological test methods;

• microbiological specifications;

• selection and use of preservatives;

• microbiological test methods used in routine manufacture and product development;

• rapid methods of microbiological testing.

Проект 511092
-
1
-
Tempus
-
2010
-
1
-
UK
-
JPCR

«Улучшение учебных программ Биотехнология (фармацевтический инжениринг)»

The EU Qualified Person (QP Study Guide
-

UK)


8:


Analysis and testing

The sampling and testing of materials does not by itself assure product quality. It must be
seen as one part of a comprehensive ‘Quality management system’, including QA and GMP,
which must be correctly implemented and controlled.

The data generated by laboratory testing of samples must be evaluated before materials are
released for sale.

Applicants will be expected to demonstrate an understanding of the following:

• GCLP (Good Control Laboratory Practice);

• quality control of sterile and non
-
sterile dosage forms;

• interpretation of analytical data and non
-
conforming results;

• the principal qualitative and quantitative analytical methods in common use;

• analytical chemistry as relevant to the properties of medicinal products and materials;

• the principles of method selection and validation;

• the design of sampling regimes;

• biological test methods and interpretation of results;

• physical and
organoleptic

testing;

• stability testing (protocols & methods);

• the significance of degradation, contamination and adulteration of pharmaceutical
materials;

• the types, purpose, significance and management of systems of in
-
process control;

• the International Conference on
Harmonisation

(ICH) guidelines for method validation,
impurities and

stability testing;

Проект 511092
-
1
-
Tempus
-
2010
-
1
-
UK
-
JPCR

«Улучшение учебных программ Биотехнология (фармацевтический инжениринг)»

The EU Qualified Person (QP Study Guide
-

UK)


9:


Pharmaceutical packaging

It is a requirement of GMP that holders of Manufacturing
Authorisations

establish
procedures for their packaging operations to
minimise

the risk of cross
-
contamination, mix
-
up or substitutions. The Qualified Person must understand the importance of controlling
packaging components (both primary and printed materials) throughout the supply chain to
assure the quality of finished products.

Applicants will be expected to demonstrate an understanding of the following:

• control of packaging components by suppliers and throughout production;

• the chain of systems which ensure the integrity and accuracy of textual information from
originator to routine production;

• the layout and
organisation

of packaging operations;

• causes of label and other printed component mix
-
ups;

• packaging and
labelling

processes and equipment;

• the testing of packaging materials including pack integrity testing;

• product security (automated systems, reconciliation, line clearance etc);

• in
-
process controls;

• effects of packaging materials on product stability;

• selection of packaging materials;

• tamper
-
evidence and anti
-
counterfeiting measures.

Проект 511092
-
1
-
Tempus
-
2010
-
1
-
UK
-
JPCR

«Улучшение учебных программ Биотехнология (фармацевтический инжениринг)»

The EU Qualified Person (QP Study Guide
-

UK)


10:


Active pharmaceutical ingredients

The Qualified Person must understand the influence of manufacturing pathways and
associated physical and
physico
-
chemical attributes, of both active pharmaceutical
ingredients and major
excipients
, on the quality of the finished dosage form.

Applicants will be expected to demonstrate an understanding of the following:

• the steps commonly taken in the manufacture of active pharmaceutical ingredients and
excipients

(including biopharmaceuticals), their purpose and limitations;

• the generation of impurities, their identification, quantification, and elimination;

• the
physico
-
chemical and biological properties of active pharmaceutical ingredients, and
excipients
, and

their effect on the attributes of the final dosage form;

• the specific requirements for bulk materials intended for sterile products;

• the nature of controls for the manufacture of bulk biological and biotech products;

• auditing of API manufacturers.

Проект 511092
-
1
-
Tempus
-
2010
-
1
-
UK
-
JPCR

«Улучшение учебных программ Биотехнология (фармацевтический инжениринг)»

The EU Qualified Person (QP Study Guide
-

UK)


11:



Investigational medicinal products

The manufacture, packaging and distribution of investigational medicinal products must be
controlled. There are significant differences between the manufacture of IMPs and licensed
dosage forms. The Qualified Person must understand these differences together with the
safeguards required to assure the quality of IMP supply.

Applicants will be expected to demonstrate an understanding of the following:

• specific GMPs associated with the manufacture of investigational medicinal products;

• the control of active and placebo forms;

• the control of packaging operations and blinding;

• the control and release of imported IMPs;

• the control and release of comparators;

• effective batch documentation, sampling and batch release;

• change control and material traceability;

• controls surrounding the procurement of Clinical Trial (CT) supplies;

• the principles of clinical trial design and Good Clinical Practice (GCP).