Summary Record of the Pharma Workshops Eng.doc

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Summary Record
o
f the Workshops

on


Pharmacovigilance


and


Drug
Quality

Control



Tehran
, 19
-
21 July
2010


Background


Pharmacovigilance and Drug Quality Control are among those fields which have
been identified as priority areas by the First Meeting o
f the ECO High Level Drug
Regulatory
Authorities (HLDA) held in Tehran on 13
-
15 November 2007.


2.

The “Pharmacovigilance” and “Drug Quality Control”
Workshops were

held
i
n
Tehran from 19
-
21 July 2010. The Workshops were
hosted
by
the
Ministry of Health an
d
Medical Education

of the Islamic Republic of Iran,
Deputy for Food and Drug,
in
collaboration
with
the ECO Secretariat
.




Introduction


3.

Pharmacovigilance is the science and activities relating to the detection
assessment, understanding and preventio
n of adverse
reactions to drugs
or any other
drug
-
related problems. Pharmacovigilance is an umbrella term used to describe the
processes for monitoring and evaluating adverse drug reactions (ADRs)
especially for the
new medicines introduced to
the marketpl
ace, and
it is considered as a
key component of
effective drug regulation systems. The ultimate goal of pharmacovigilance is the safe and
proper use of effective medicines of all types.


4.

Pharmaceutical products, more commonly known as medicines or drugs
, are a
fundamental component of both modern and traditional medicine. Medicines are
identified through an evidence
-
based process and quality, safety, efficacy. The safety of
medicines is an essential part of patient safety. Global drug safety depends on s
trong
national systems that monitor the development and quality of medicines, report their
harmful effects, and provide accurate information for their safe use. Medicine safety must
be followed by careful patient monitoring and further scientific data coll
ection. This
aspect of drug monitoring is called post
-
marketing surveillance
.


Objective
s


5
.

The ob
jectives
and expected goals of
these workshops
were

to
give an opportunity
to the participants to
share the latest breakthroughs on quality control of biolo
gical and
non
-
biological medicines and findings on pharmacovigilance among the ECO Member
States. The participants
highlighted the strong or vulnerable points of Member States
based on which a more practical joint work plan can be formulated
. The
y

were als
o
able
to learn:

-

how to develop National Adverse Drug Reaction Monitoring Center in the
country

-

how to implement Spontaneous Reporting System in the country


2

-

how to
identify and evaluate adverse drug events through better reporting
systems, skilful technic
al investigation of incidents and responsible sharing of
data
,
develop capacity to anticipate adverse events and to probe systemic
weaknesses that might lead to problems

-

identify existing knowledge resources, within and outside the health sector

-

make impro
vements in the health
-
care delivery system



Participation


6
.

Delegates from
all ECO Member States namely:
the
Islamic Republic of
Afghanistan, the Republic of Azerbaijan, the Islamic Republic of Iran (Host), the
Republic of Kazakhstan, Kyrgyz Republic, t
he Islamic Republic of Pakistan, the
Republic of Tajikistan
,
the Republic of Turkey
, Turkmenistan and the Republic of
Uzbekistan

participated in the Workshops.
List of participants
and work programme

are

enclosed a
t

A
nnex I
.



7
.

The workshops were conduc
ted in an interactive manner and the programme
consisted of presentations, discussions, group activities.

The presentations covered most
of the aspects of pharmacovigilance and drug quality control.
During each presentation,
the participants were invited
to share their experiences

and

achievements made by their
respective countries
relating to
the areas covered in the presentations. Questions raised by
the participants were addressed by the presenters and
the
facilitator
s
.
The participants
were provided wi
th
pharmacop
o
eia

books of Iran.


Welcoming

Remarks


8
.

Amb. Hassan Taherian, Deputy ECO Secretary General, i
n his opening remarks
welcomed the participants of the Workshops. He thanked and appreciated the
Government of the Islamic Republic of Iran as wel
l as the
Ministry of Health and
Medical Education,

Deputy for Food and Drug,
for hosting and making excellent
arrangements for these Workshops.


9
.

He said that active participation in deliberations and valuable professional
contributions of the delegates
would enable the workshops to accomplish their task
successfully.
Copy of opening remarks is attached at
Annex II
.


Opening Remarks


10
.

Dr. M. R. Shanesaz, D
ir
ector General of Division of Pharmaceutical Affairs

in his
speech warmly welcomed the delegates
of the ECO
M
ember
S
tates to Islamic Republic
of Iran.


1
1
.

H
e regarded human safety as having a common significance among all the
religions therefore creating opportunities for relations between various nations through
the need for medicines.
H
e emphasize
d to the fact that all ECO
M
ember
S
tates enjoy a
rich cultural background in the field of medicines and pharmaceutical and that the
intellectuals of this regions widely contribute to the development of these sciences.



3

1
2
.

While commenting on the relation

between the ECO
M
ember
S
tates
h
e
highlighted that keeping in account the historical background of the
M
ember
S
tates the
relationship is insufficient as compared to other Western and Asian Nations as it creates a
strong scientific exchange and hence streng
thening the medicinal and pharmaceutical
relations.
H
e also shared the achievements of Islamic Republic of Iran in the field of
Pharmaceutical after the Islamic Revolution,
a
s before the Islamic Revolution Iran was a
major importer of Pharmaceutical and af
ter the Revolution it fulfilled 96% of its
pharmaceutical requirements and achieved the certificate for the regulatory authority over
production of vaccines.


1
3
.

On part of Islamic Republic of Iran and as a human duty he wished to share the
pharmaceutical

experiences and technical know
-
how among all the countries in order to
promote health
-
base relations between countries.

Text of his statement is attached at
Annex
-
III.



Inauguration


1
4
.

In his inaugural statement
, Dr. M. H. Nicknam, Acting Health Minist
er for
International Relations Affairs

he welcomed the delegates to visit Iran to participate in
the workshops. He appreciated and thanked for the cooperation extended by the officials
of the Ministry of Foreign Affairs as well as the efforts made by ECO S
ecretarial for
providing the necessary facilities for holding the workshops. He particularly appreciated
MOH&ME,
Deputy for Food and drug, for hosting these workshops.


1
5
.

The social, economical challenges confronted to today’s world require a close
coope
ration that is proportionate with the needs and situations of every region, he said.
The cultural, religious affinities and historical bonds, the common needs and deep
understanding among ECO Member States can lead to an effective interaction in health
sec
tor including pharmaceutical field.


1
6
.

He made a reference to t
he First ECO Health Ministers Meeting held in Baku
(Azerbaijan) in February 2010 which clearly drawn up the ways for expanding the
existing joint cooperation among Member States as well as be
nefiting from the support
and technical experiences of the International Organizations that are active in the fields of
health and pharmaceutical affairs. He said that the Ministry of Health and Medical
Education has constantly prioritized the expansion of

health cooperation among
neighbouring

countries and ECO Member States.

Text of his statement is attached at
Annex
-
IV.



Pharmacovigilance



(
19
th

July
2010)


Why drug Monitoring? Methods Available for Drug Safety

Monitoring


an
Overview

1
7
.

Professor Khe
irollah Gholami made a presentation on the topic.
While describing
the
history of drug safety and adverse drug reaction
, he said that the adverse reaction of

4

the drug is
as
old as medicine
.
T
he Adverse Drug Reactions are the 4
th

to 6
th

largest
cause of mo
rtality in the USA (Lazarou J. et al., 1998). While elaborating the impact of
drug on humanity he said that the percentage of hospital admissions due to drug related
events in some countries
are

about or more than 10%. He also
discussed
the econo
mic
impact

of the drug reaction and
said that the total cost of drug
-
related morbidity and
mortality exceeds the cost of the medications themselves
.

Sometimes the total cost of
ADRs is double the cost of medicines.

1
8
.

The most vulnerable section of the mankind to
the ADRs
is:

the

young, old or
female

and those who are
taking multiple therapies
,
50% of patients on

5 drugs or more
,
have more than one medical problem
,
have a history of allergy or a previous reaction to
drugs
.
Dr. Gholami cautioned about this misperc
eption
that
if the drugs manufactured in
UK or USA
,

there is no need to
w
orry. He said if there is a drug,
there is a risk. One
ha
s

always to be careful rather to worry about its reaction, regardless of the manufacturing
states.
Categories of the ADRs wer
e explained and various methods of ADR reporting
and
misconceptions

about ADR Reporting

were also discussed.


1
9
.

Major aims of pharmacovigilance were elaborated.
The ultimate goal of
pharmacovigilance is

improving pharmacotherapy.

Presentation made by D
r. Gholami is
attached at
Annex
-
V.


Medication E
rr
ors


20
.

Dr. Fanak Fahimi,
Associate Professor of Clinical Pharmacy, Shahid Beheshti
University

made a presentation on medication errors. She defined the medication errors
as “any preventable event that may

cause or lead to inappropriate medication use or
patient harm, while the medication is in the control of health care professional, or patient.
Such events may be related to professional practice, health care products, procedures, or
systems”.

She also hi
ghlighted the common causes and types of the medication errors.
She said that
any of the persons involved in medication can be
source of medication error
e.g.
physician, nurse, pharmacist

or pharmacy technician etc.


2
1.

Dr. Fahimi also referred to variou
s studies conducted regarding medication errors
which is a matter of concern as the medication error can lead to maximum loss i.e. loss of
life.
She said that these errors can be prevented by taking care of the various
precautionary measures in labeling, c
lear prescription, use of exact dosage, counseling
the patients for medication use and proper diagnosis and recommending proper medicine.
She also
emphasized
that all the stakeholders of the medicines should keep themselves up
with today knowledge, review

existing drug therapy and patient’s current status before
prescribing a new drug, and be familiar
to the
formulary system and approved
abbreviations and complete and clear prescription.

Her p
resentation is attached at
Annex
-
VI.


Definitions and Mechanisms

of Adverse Drug Reactions (ADRs)

2
2
.

Dr. Jamshid Salamzadeh,

Associate Professor of Clinical Pharmacy, Shahid
Beheshti University

in his presentation discussed the definitions, general terminology,
classification and mechanisms of ADRs. A comprehensive de
finition of an ADR
proposed by Edwards IR and Aronson JK is “an appreciably harmful or unpleasant

5

reaction, resulting from an intervention related to the use of a medicinal product, which
predicts hazard from future administration and warrants prevention o
r specific treatment,
or alteration of the dosage regimens or withdrawal of the
product”.

2
3
.

He also
highlighted
the drawbacks of some
of the
definitions. Adverse reaction &
adverse

effect are interchangeable. Adverse effect is seen from the point of view

of the
drug. Adverse reaction is seen from the point of view of the patient. Any substance that is
capable of producing a therapeutic effect can also produce unwanted or adverse effects.
The risk of adverse effects ranges from
very low to high.

He said th
at

for the purpose of
reporting
adverse effects we need a common communication language. 50%
of
the cases
of drug
-
related injury are from potentially avoidable ADRs. Different categories of
ADRs
include,
A: Dose
-
related (Augmented)
;
B: None
-
dose
-
related (
Bizarre)
;
C: Dose
-
related & Time
-
related (Chronic)
;
D: Time
-
related (Delayed)
;
E: Withdrawal effects (End
of use)
;
F: Unexpected failure of therapy (Failure
)

2
4
.

In conclusion of his presentation he said that ‘
an adverse drug reaction is a
harmful or unple
asant reaction directly caused by the drug at normal doses, during
normal use.

Presentation attached at
Annex
-
VII


Preventable Adverse Drug Reaction; A Focus on Drug Interactions


2
5
.

Dr. Fariborz Farsad
, Assistant Professor of Clinical Pharmacy, Iran Uni
versity of
Medical Sciences
made a presentation on
Preventable Adverse Drug Reactions. While
highlighting the drug interactions he discussed an approach to prescribing drugs in ways
that avoid adverse drug interactions as a cause for preventable medication

errors.
The
mechanisms through which
drug interaction can occur
are mentioned below:




Even before drugs enter the body due to formulation incompatibility, or at any
point in the process of absorption, distribution, metabolism, and elimination.



Drugs can
bind to each other in the GI tract, preventing absorption, and reducing
systemic availability.



In theory, drugs could interact in the plasma via protein
-
bumping reactions but,
despite the emphasis placed on these in many texts and pharmacology courses,
th
ere are no known clinically relevant examples in which this mechanism is
responsible.



A large number of important interactions do occur in the liver and GI tract due to
changes in the rates of drug metabolism brought about by other medicines that are
indu
cers or inhibitors of drug metabolism.



A few interactions occur through co
mpetition at drug transporters.



Finally, interactions can occur at the level of drug action such as the combination
of verapamil, a calcium channel blocker, and a beta
-
blocker. Bo
th slow the heart
rate by different mechanisms, and the combination is relatively contra
-
indicated
because heart block can result.
Because of th
is interaction many textbooks and
computer programs warn against concomitant use of any beta
-
blocker and any
ca
lcium channel blocker. This creates a great deal of confusion and distrust of
drug interaction warnings, because most health care providers know that drugs in
these two classes are often employed successfully and safely in patients with
hypertension.
Pre
sentation attached at
Annex
-
VII
I.



6

Individual
Case
Causality Assessment



2
6
.

Dr. Gloria Shalviri
, director of Iranian Pharmacovigilance Monitoring Center
demonstrated a presentation on the topic. She said that the spontaneous reporting is
considered
the b
ackbone of Pharmacovigilance, which is not a perfect method.
Aggregated assessment and interpretat
ion are used for: s
ignal detection;
r
eg
ulatory
measures; publication;
identifying
i
nteractions and risk factors;
conducting
s
erial
(clinicopathological) study
;
f
requency estimation.
Major drawbacks are:
under
-
reporting,
u
ncertainty with regard to the causal involvement of the drug.


2
7
.

She explained the definition of Case
-
causality assessment (Drug
-
relationship
assessment or imputation) as “Structured or stan
dardized assessment in

an

individual case
of the likelihood of a causal association between suspected drug and the adverse event”.
She also discussed the efficiency and deficiency of causality assessment. She elaborated
various categories of causality de
fined by WHO, which are: certain, probable/likely,
possible, unlikely etc. Diseases or other drugs provide plausible explanations
in some
causality categories,
like
“possible”.

Australian Causality Categories were also discussed
as u
nclear/unlikely/unass
essable
,
possible.
Some
other circumstances
involved in case
causality assessment
include alternative explanation, more than one drug is suspected,
data are incomplete, recovery follows withdrawal of more than one drug, time
relationship is not clear, outc
ome of the reaction is not recorded, recovery follows
therapy in addition to withdrawal of the drug.


2
8
.

Prevailing
Case Causality Assessment systems are
Karch and Lasagna, 1977,
Kramer et al, 1977, Emanueli & Saccheti, 1980,
Begaud et al, 1981 (The Frenc
h
imputation system),
Venulet et al, 1986, Probability calculation (Bayes’
Theorem=relationship between the probability of a preposition of before and after
acquisition of additional data.), Aetiological
-
Diagnostic systems (Be’nichou’s group),
German syste
m. The commonality in different systems
ca
n

be defined as “t
ime and
sometimes location association, challenge, dechallenge, rechallenge; pharmacology;
c
linical, lab;
e
xclusion or likelihood of other causes

. The European Causality
Categories (ABO)
also
c
ame under discussion. Major uses of causality assessment are

s
ignal detection,
d
rug regulation,
scientific

publications

and

d
ata exchange

.
P
resentation is attached at
A
nnex
-
I
X.



How to Evaluate and Report Suspected ADRs

(
Group Activity)


2
9
.

The partic
ipants were divided into three groups and g
a
ve the task
:


How to
evaluate and report suspected ADRs


from available information.
Dr. Gloria Shalviri

coordinated the group activity. The participant
s

actively participated in the group activity
and each group

demonstrated the presentation prepared by them and the information
,
expertise
and experiences of
delegates
and working
in their respective countries
were
shared by the participants.


Literature Sources for ADR Information


30
.

Dr. Gloria Shalviri

provide
d various useful sources for obtaining ADR
information. The participants
appreciated the effort of the presenter for providing them
source information.
These include journals, secondary review journals
,

reference books,

7

textbooks, reference online, compute
rized literature, National ADR

Bulletins
,
WHO
Publications

etc

Presentation showing important web
-
links attached at
Annex
-
X.




Drug Quality Control”


20
th

July 2010


The role of
Food and Drug Control Laboratories

(
FDCL
)

on Drug Quality Control


31
.

Dr. H
osein Rastegar
, Director General of Food & drug National Control
Laboratories,
demonstrated
a presentation on the
role of Food and Drug Control
Laboratories (FDCL) on Quality
. He described the d
efinitions
, q
ualitative
and
quantitative methods of
q
uality
c
ontrol
.

He
underlined the main
quality control elements
which include “
selection and managing control materials

(importance of sampling
process)
;
a
nalysis of QC data; Monitoring quality control data

. Process for achieving
accurate and precise results in

quality control was demonstrated.
Measures of Dispersion
or Variability

of analytical data
were also elaborated.


3
2
.

Quality Control requirements such as
data as a laboratory product
,
specific
equipped lab according
to the
products
,
calibrated
instrumen
ts for precise results
,
expert
staffs for achieving precise results

and
q
uality system and suitable
organization for
validated results are necessary.
Organization
al set up of
Food and Drug Control Labs
(
FDCL)

of Iran was also demonstrated.

Presentation att
ached at
Annex
-
XI.


Overview of Drug Regulations in Iran



3
3
.

Dr. Mahboubeh Valadkhani demonstrated a presentation on topic. While
explaining the
background with regard to
regulations on this subject
,

she said that
first
A
ct for Food, Beverages, Pharmaceu
ticals and Medical Devices

was approved by the
P
arliament in
1955
,

amended in
1967

& 1988

and later

on in 2010
. As a result of which
Guidelines, SOPs and Checklists are now being designed and implemented using
references from international bodies and
ex
pe
rt’s comments.

Various article
s

of the
A
ct
were
explained
.

3
4
.

Organization
al

set up of the
National Control Authority for Pharmaceutical
Products

was also demonstrated. The mission of the National Policy is

to

p
romote and
protect public

health
and assure
availability of
safe and effective

drugs to
people
.

R
egistration of pharmaceutical products for imports and
documents required for
registration were illustrated in detail. Various biological offices and their activities and
the efforts being made for their

improvement were underlined.
Presentation attached at
Annex
-
XII.


Quality Assurance


3
5
.

Dr. Haleh Hamedifar
, in h
er

presentation elaborated the
topic.
She
said
Quality
Assurance is
a program
which ensures standards of quality with
systematic monitoring
and evaluation of various aspects of a project, service, or facility.

Two key principles

8

characteri
z
e
s

the
Q
uality Assurance are”

"fit for purpose" (the product should be suitable
for the intended purpose) and "right first time" (mistakes should be elimina
ted). Q
uality
assurance
includes regulation of
the

quality

of

raw materials,
intermediate materials or
substrates,
products and components; services related to productio
n; and management,
production and inspection processes.


3
6
.

It is important to realize that

quality

is determined by the intended users, clients or
customers, not by society in general
. I
t is not the same as 'expensive' or 'high quality'.
Even goods with
low prices can be considered quality items if they meet a market need.
Q
uality assurance
is
more

than just testing the quality of aspects of a product, service or
facility, it analyzes the quality to make sure it conforms to specific requirements and
compl
y with established plans.



3
7
.

Quality assurance is a wide ranging concept covering all matters that individually
or collectively influence the quality of a product. With regard to pharmaceuticals, quality
assurance can be divided into four major areas

i.
e.

quality control, production,
distribution, and inspections. The development of norms, standards and guidelines to
promote quality assurance is an integral part of WHO’s Constitution and has been
endorsed and supported through numerous World Health Assem
bly resolutions, and more
recently in those on the Revised Drug Strategy.

Presentation attached at
Annex
-
XI
II
.



Good Laboratory Practice (GLP)


3
8
.

Dr. Amir Mehdizadeh made a presentation on

Good Laboratory Practice (GLP).
He said that GLP
regulations go
vern the conduct of non
-
clinical laboratory safety studies
and
is concerned with
equipment calibration, method and process validation, personnel
training,
sampling, specifications and testing as well as the organization, documentation
and release procedure
s which ensure that the necessary and relevant tests are carried out
.
Therefore
, materials are
not
released for use,
nor the
products released for sale or supply,
until their quality has been judged satisfactory. Quality
c
ontrol is not confined to
laborat
ory operations, but must be involved in all decisions which may concern the
quality of the product. The independence of Quality Control from
p
roduction is
considered fundamental to the satisfactory operation of Quality Control
.


3
9
.

Each holder of a manufa
cturing authorization should have a Quality Control
Department. This department should be independent and under the authority of a person
with appropriate qualifications and experience, who has one or several control
laboratories at his
/her

disposal. Adequ
ate resources must be available to ensure that all
the
q
uality
c
ontrol arrangements are effectively and reliably carried out.

Presentation
attached at
Annex
-
X
I
V.


Method Validation


40
.

Dr. Farzad Kobarfard, in his presentation underscored the importance a
nd
necessity of the validation. He said that validation is conformation by examination and
provision of objective evidence that the particular requirements for a special intended use
are fulfilled. Method validation is the process of establishing the per
formance
characteristics and limitations of a method and the identification of the influences which
may change these characteristics and to what extent. It is also the process of verifying

9

that a method is fit for purpose i.e. for use for
assay of active
pharmaceutical ingredients,
or determination of related substances of finished products in the stability study
analytical
problem. Various internationally accepted definitions, purposes, tools and parameters of
validation were pointed out.


41
.

Important

components of
method
validation like
precision, accuracy, sensitivity,
l
inearity and range,
s
pecificity
, r
eproducibility
,

r
obustness were discussed in the
presentation. Some common perceptions of validation were highlighted.
Presentation
attached at
Annex
-
XV
.


Third Day

21
st

July 2010


M
edical Biotechnology Trends


4
2
.

Dr.
Fereidoun Mahboudi, gave a presentation on the topic. He said that the
understanding of disease from a systems perspective would change our current brand of
medical practice so radically

in the next 10 to 15 years that all healthcare industries, even
medical schools, would need to restructure almost every aspect of their operations.
Systems biology advances would allow for the majority of drug discovery to be
conducted in silico. Health
care would be centrally delivered

and
smart cards would
contain a person’s genome and health records. Combination therapies would be routine
as new medicines combine a diagnostic with a drug and a delivery device.


4
3
.

Worldwide, the pharmaceutical mark
et would have doubled to $1.3 trillion; the
expected revelation in the high
-
tech convergence of nano,
-
bio, information, and materials
technologies bolsters biotech. In biotech land, the top
-
selling drugs had mixed report
card. Industry wide, biotech prod
uct sales grew approximately 8% to $89 billion in 2007.
Genentech increased its 2007 sales to 8.5 billion, a 19% increase compare to 2006. In
terms of drugs, Avastin rose 32% to 2.3 billion. He said that this was a concern that our
research system is fa
lling behind the needs of society to determine the balance of benefit
and risk from drugs, and
devices. Personalized medicine

using genetics or other
molecular biology
-
based diagnostic tests to customize treatment for a particular patient
would increase d
ramatically. Finally, business models would be radically
different.
Presentation attached at
Annex
-
XVI.


Quality control of Blood Products


4
4
.

Dr. Siamac Samiee made a presentation on this subject. He said that blood and
blood products, as an essential p
art of modern health care, if used correctly can save life
and improve health. The major concern, the transmission of infectious agents by blood
and blood products has focused particular attention on the potential risks of transfusion.
The World Health Org
anization (WHO) proposed strategy to promote global blood safety
and minimize the risks of blood and blood products consists of:


-

The establishment of nationally coordinated blood transfusion services with
quality systems in all areas.

-

The collection of b
lood only from voluntary non
-
remunerated donors from
low
-
risk populations.


10

-

The screening of all donated blood for transfusion
-
transmissible infections,
and good laboratory practice in all aspects of blood grouping, compatibility
testing, component prepara
tion and the storage and transportation of blood
and blood products.

-

A reduction in unnecessary transfusions through the appropriate clinical use of
blood and blood products, and the use of simple alternatives to transfusion,
wherever possible.


There are
critical steps to assure safety of blood products:

-

Donor recruitment and selection

-

Medical examination of donor and blood collection

-

Screenings (microorganisms transmissible by blood or blood products, blood
grouping)

-

GMP and stock management

-

Plasma pool
screening (Recruiting nucleic acid based techniques as well as
EIA)

-

Virus removal/inactivation

-

Surveillance (Hemovigilance and Pharmacovigilance)


Presentation attached at
Annex
-
XVII.


Quality Control of Vaccines

(Group Activity)


4
5
.

A group activity was
coordinated by Dr. Mahmoud Alebouyeh. The participants
were divided into three groups and gave the task on the Quality Control of Vaccines. The
participant actively participated in the group activity and each group demonstrated the
presentation prepared
by them and the information and experiences of delegates in their
respective countries were shared by the participants.


Physico
-
Chemical Quality Control of Vaccine


4
6
.

Dr. Mojgan Taghizadeh

made a presentation on the topic.
She said that Vaccines
need t
o particulate attention because of their nature and target population. She
highlighted the quality standards and procedures involved in testing of intermediate, bulk
or final product by appropriate tests. National Control Laboratories (NCL) has a vital
ro
le in assuring the quality of vaccines. While speaking on protocol review she said that
the model protocol given in WHO requirements for each product is to ensure production
of batch meets authorization as determined by in
-
process controls and tests on fin
al
container meets specifications given in market authorization. She also elaborated the
retest policy and identification methods which are:


-

Immunochemical methods are based on the selecti
ve, reversible and non
-
covalent
c
binding of antigens by antibodies
. The reagents necessary for many
immunochemical methods are available as commercial assay kits.

-

Immunoprecipitation methods (include flocculation and precipitation reactions) in
which used unlabelled antigen and antibody are mostly used.

Various t
ests p
erformed on final bulk or final products
were also notified.

Factors
affecting selection of tests are validated method, equipments (availability) and staff
(experience and training).
Presentation attached at
Annex
-
X
V
I
II
.


11


Quality Control of
Genetically Mod
ified Organisms

Products


4
7
.

Dr. Maryam Rabiei, made a presentation on the topic.
In her presentation she
described the history and background of
Genetically Modified Organisms
(
GMO
)

and it
goals. She said that GMO is the organism whose genetic structure

has been altered by
incorporating a gene to express a desirable trait by modern biotechnology. Right now GM
crops are grown in more than 130 million hectares in 25 countries. About 70% of total
GM crops are made by USA, followed by Argentina, Brazil, Cana
da, India and China.
Main GM crops are soybean, maize, cotton and canola. The main goals of GM crops are
herbicide tolerance and pest resistance. Crops with Altered Nutrition and Law &
Regulations of GM crops were discussed. Method for genetic modificatio
n of crops and
Gene Transformation Methods were described. She highlighted the advantages and
disadvantages of the GMO as well as implications of genetic manipulation & human
health. In conclusion, she said, new genetic technologies are causing drastic cha
nges and
in order to evaluate GMO, many testing and researches are needed to be done as
“Genetically Engineered Foods are Different. It is not same as conventional foods
”.
Presentation attached at
Annex
-
X
I
X.


Quality Control of Recombinant Proteins


4
8
.

D
r. Mahmoud Alebouyeh, made a presentation on the Quality Control of
Recombinant Proteins. While highlighting the rapidly growth in the production and use
of recombinant proteins in recent years, he said that the quality control of recombinant
proteins requ
ires selection of multiple assays that are complementary for the evaluation
of identity, purity, potency, strength and stability of these products. The laboratory test
methods and
s
pecifications for biological/ biotechnologist products should be establishe
d
to ensure lot
-
to
-
lot consistency.

To achieve to this goal, samples selected for finished
products testing should be representative for the homogenous fill. So, each individual
sample should have characteristics identical to all other samples and be repre
sentative of
the lot as a whole.


4
9
.

In case of almost of recombinant protein, the degradation pattern is complex and
no single method can address all of the modes of degradation. Thus, a series of individual
assays are used to detect subtle molecular ch
anges. Selection of the test methods in each
laboratory depends on the access to the equipments and relative test methods (standard
operating procedure) and it may be varied lab by lab. However, the final results should be
the same: effective and safe prod
uct for use. In his presentation, he showed the current
laboratory tests that are being done in manufacturers’ quality control departments to
release the safe and effective product for popular use.

Presentation attached at
Annex
-
XX.


Visit to Jaber Ebne Ha
yyan Pharmaceutical Co.


50
.

In the afternoon of the third day of the Workshops, a visit
to
Jaber Ebne Hayyan
Pharmaceutical Company located in the outskirts of Tehran city

was arranged
.
A

briefing, depicting the history, manufacturing capacity, site plan

and future prospect
s

of
company
as well as organizational chart
was given by Dr.

Mo
nta
s
eri
, managing director
of the company
. The Company was established in 1960 with the name of Squibb Iran,

12

which was changed in 1979 as Jaber Ebne Hayyan Pharmaceutical

Company
. Initially
the company was producing few medicines under brand names. After Islamic revolution
in Iran it started to manufacture antibiotics. Today the company is equipped with modern
technology and is producing 68 products (28 new products in pip
eline) with the expertise
of 547 qualified personnel. The company produces various antibiotics consisting of
capsules, tablets, powders for oral suspension, sterile powder for injection and ointments

as well as
inhalers.
Its annual production is
120 millio
n
vials.


51
.

Dr.

Mo
nta
se
ri
informed the participants that Jaber Ebne Hayyan has a superior,
high tech quality control system. Acquiring ISO 17025 certificate from DAP (Germany)
is a major achievement for company’s quality control laboratory system. Its
research and
development laboratory is dedicated to developing innovative, cost effective medicines
which address significant unmet medical needs in order to provide health care to the
society. It is the 4
th

largest pharmaceutical company of total 80 pharm
aceuticals of Iran.
The Company’s priority export markets are the Middle and CIS countries. It has the
potentials to expand its exportation activities to other parts of Asia, Africa and Europe.


5
2
.

The participants were escorted to witness the various
production units
especially
Inhalers and different parts of quality control laboratories
of the Company and were
briefed about their functions and capacity.



22
nd

July 2010


Visit to
Pasteur Institute

of Iran



5
3
.

A visit to the
Production & Research Com
plex (Karaj) of the
Pasteur Institute of
Iran was arranged on
Thursday, 22
nd

July 2010 (in addition to the original programme)
.
The
Head of the International and Public Affairs Department briefed the
participants
about the
history and functions of the Ins
titute. The Institute was
established
in 1920
with the aim to pave the way for advanced research to provide innovative programs in the
basic and applied medical sciences and also production of biopharmaceuticals and
diagnostic kits with special emphasis o
n infection disease. Since 1983 the Institute is
offering wide range of teaching activities in the area of pharmaceutical biotechnology at
P
h
.D level. The major products at the Institute
,

among other
s,

are Hepatitis B Vaccine
and BCG Vaccine.
This Institu
te is the only manufacturing unit of Hepatitis B Vaccine in
the Middle East and 7
th

in the world.


5
4
.

Escorted by
Dr. Daryoush Norouzian
,

Production Director of the Institute, t
he
participan
ts got the opportunity to witness the process of
for
mulation, fi
lling and
packaging of the HB Vaccine. They visited the CCTV monitoring unit and witnessed its
functions.
They also visited and acquainted themselves with the functions of the units of
Quality Control Department, which include
M
ycopla
s
ma,
Environmental Mo
nitoring
Lab, Physical
-
Chemistry Lab, Instrumental Room, Immunochemistry Lab,
Chromatography Lab, Electrophorsis Lab, Fermentation Room, Microbiology Lab and
Bioassay Lab.

At the end the participant visited the Quality Assurance Department of the
Institut
e.
A working lunch was also arranged.


5
5
.

In the afternoon the participants were taken to see SaadAbad Cultural &
Historical Complex, which is
stretched on 110 Hectare land. There are a number of

13

museums

as well as traditional restaurant and coffee shop
s
.

The participants were happy
to visit this complex.


5
6
.

The participants were awarded with certificates by
Dr. M. R. Shanesaz, Director
General of Division of Pharmaceutical Affairs
, Ministry of Health, Amb. Taherian ECO
Deputy Secretary General and M
r. Fatih Unlu, the then Acting ECO Secretary General.
The participants appreciated the efforts of the Ministry of Health, Deputy for Food and
Drug and ECO Secretariat for organizing the Workshops and making excellent
arrangements. They also expressed their

satisfaction for the deliberations of the
Workshops.