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Transcript
Summary Record of 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 of 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 in
Tehran from 19-21 July 2010. The Workshops were hosted by the Ministry of Health and
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 prevention 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 marketplace, 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 strong
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 collection. This
aspect of drug monitoring is called post-marketing surveillance.
Objectives
5.
The objectives and expected goals of these workshops were to give an opportunity
to the participants to share the latest breakthroughs on quality control of biological 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. They were also able
to learn:
how to develop National Adverse Drug Reaction Monitoring Center in the
country
how to implement Spontaneous Reporting System in the country
-
-
how to identify and evaluate adverse drug events through better reporting
systems, skilful technical 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 improvements 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, the 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 at Annex I.
7.
The workshops were conducted 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 facilitators. The participants
were provided with pharmacopoeia books of Iran.
Welcoming Remarks
8.
Amb. Hassan Taherian, Deputy ECO Secretary General, in his opening remarks
welcomed the participants of the Workshops. He thanked and appreciated the
Government of the Islamic Republic of Iran as well 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, Director General of Division of Pharmaceutical Affairs in his
speech warmly welcomed the delegates of the ECO Member States to Islamic Republic
of Iran.
11.
He 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. He emphasized to the fact that all ECO Member States 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.
2
12.
While commenting on the relation between the ECO Member States he
highlighted that keeping in account the historical background of the Member States the
relationship is insufficient as compared to other Western and Asian Nations as it creates a
strong scientific exchange and hence strengthening the medicinal and pharmaceutical
relations. He also shared the achievements of Islamic Republic of Iran in the field of
Pharmaceutical after the Islamic Revolution, as before the Islamic Revolution Iran was a
major importer of Pharmaceutical and after the Revolution it fulfilled 96% of its
pharmaceutical requirements and achieved the certificate for the regulatory authority over
production of vaccines.
13.
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
14.
In his inaugural statement, Dr. M. H. Nicknam, Acting Health Minister 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 Secretarial for
providing the necessary facilities for holding the workshops. He particularly appreciated
MOH&ME, Deputy for Food and drug, for hosting these workshops.
15.
The social, economical challenges confronted to today’s world require a close
cooperation 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
sector including pharmaceutical field.
16.
He made a reference to the 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 benefiting 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”
(19th July 2010)
Why drug Monitoring? Methods Available for Drug Safety Monitoring – an
Overview
17.
Professor Kheirollah 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
3
the drug is as old as medicine. The Adverse Drug Reactions are the 4th to 6th largest
cause of mortality 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 economic
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.
18.
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 misperception that if the drugs manufactured in
UK or USA, there is no need to worry. He said if there is a drug, there is a risk. One has
always to be careful rather to worry about its reaction, regardless of the manufacturing
states. Categories of the ADRs were explained and various methods of ADR reporting
and misconceptions about ADR Reporting were also discussed.
19.
Major aims of pharmacovigilance were elaborated. The ultimate goal of
pharmacovigilance is improving pharmacotherapy. Presentation made by Dr. Gholami is
attached at Annex-V.
Medication Errors
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 highlighted 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.
21.
Dr. Fahimi also referred to various 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, clear 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 presentation is attached at AnnexVI.
Definitions and Mechanisms of Adverse Drug Reactions (ADRs)
22.
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 definition of an ADR
proposed by Edwards IR and Aronson JK is “an appreciably harmful or unpleasant
4
reaction, resulting from an intervention related to the use of a medicinal product, which
predicts hazard from future administration and warrants prevention or specific treatment,
or alteration of the dosage regimens or withdrawal of the product”.
23.
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 that 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: Doserelated & Time-related (Chronic); D: Time-related (Delayed); E: Withdrawal effects (End
of use); F: Unexpected failure of therapy (Failure)
24.
In conclusion of his presentation he said that ‘an adverse drug reaction is a
harmful or unpleasant 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
25.
Dr. Fariborz Farsad, Assistant Professor of Clinical Pharmacy, Iran University 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,
there 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
inducers or inhibitors of drug metabolism.
A few interactions occur through competition 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. Both slow the heart
rate by different mechanisms, and the combination is relatively contra-indicated
because heart block can result. Because of this interaction many textbooks and
computer programs warn against concomitant use of any beta-blocker and any
calcium 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. Presentation attached at Annex-VIII.
5
Individual Case Causality Assessment
26.
Dr. Gloria Shalviri, director of Iranian Pharmacovigilance Monitoring Center
demonstrated a presentation on the topic. She said that the spontaneous reporting is
considered the backbone of Pharmacovigilance, which is not a perfect method.
Aggregated assessment and interpretation are used for: signal detection; regulatory
measures; publication; identifying interactions and risk factors; conducting serial
(clinicopathological) study; frequency estimation. Major drawbacks are: under-reporting,
uncertainty with regard to the causal involvement of the drug.
27.
She explained the definition of Case-causality assessment (Drug-relationship
assessment or imputation) as “Structured or standardized 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 defined 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 unclear/unlikely/unassessable, 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, outcome of the reaction is not recorded, recovery follows
therapy in addition to withdrawal of the drug.
28.
Prevailing Case Causality Assessment systems are Karch and Lasagna, 1977,
Kramer et al, 1977, Emanueli & Saccheti, 1980, Begaud et al, 1981 (The French
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 system. The commonality in different systems can be defined as “time and
sometimes location association, challenge, dechallenge, rechallenge; pharmacology;
clinical, lab; exclusion or likelihood of other causes”. The European Causality
Categories (ABO) also came under discussion. Major uses of causality assessment are
“signal detection, drug regulation, scientific publications and data exchange”.
Presentation is attached at Annex-IX.
How to Evaluate and Report Suspected ADRs (Group Activity)
29.
The participants were divided into three groups and gave the task: “How to
evaluate and report suspected ADRs” from available information. Dr. Gloria Shalviri
coordinated the group activity. The participants 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 provided 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,
6
textbooks, reference online, computerized literature, National ADR Bulletins, WHO
Publications etc… Presentation showing important web-links attached at Annex-X.
“Drug Quality Control”
20th July 2010
The role of Food and Drug Control Laboratories (FDCL) on Drug Quality Control
31.
Dr. Hosein 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 definitions, qualitative and
quantitative methods of quality control. He underlined the main quality control elements
which include “selection and managing control materials (importance of sampling
process); analysis 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.
32.
Quality Control requirements such as data as a laboratory product, specific
equipped lab according to the products, calibrated instruments for precise results, expert
staffs for achieving precise results and quality system and suitable organization for
validated results are necessary. Organizational set up of Food and Drug Control Labs
(FDCL) of Iran was also demonstrated. Presentation attached at Annex-XI.
Overview of Drug Regulations in Iran
33.
Dr. Mahboubeh Valadkhani demonstrated a presentation on topic. While
explaining the background with regard to regulations on this subject, she said that first
Act for Food, Beverages, Pharmaceuticals and Medical Devices was approved by the
Parliament 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 expert’s comments. Various articles of the Act
were explained.
34.
Organizational set up of the National Control Authority for Pharmaceutical
Products was also demonstrated. The mission of the National Policy is to promote and
protect public health and assure availability of safe and effective drugs to people.
Registration 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
35.
Dr. Haleh Hamedifar, in her 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
7
characterizes the Quality Assurance are” "fit for purpose" (the product should be suitable
for the intended purpose) and "right first time" (mistakes should be eliminated). Quality
assurance includes regulation of the quality of raw materials, intermediate materials or
substrates, products and components; services related to production; and management,
production and inspection processes.
36.
It is important to realize that quality is determined by the intended users, clients or
customers, not by society in general. It 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.
Quality 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
comply with established plans.
37.
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 Assembly resolutions, and more
recently in those on the Revised Drug Strategy. Presentation attached at Annex-XIII.
Good Laboratory Practice (GLP)
38.
Dr. Amir Mehdizadeh made a presentation on Good Laboratory Practice (GLP).
He said that GLP regulations govern 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 procedures 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 control is not confined to
laboratory operations, but must be involved in all decisions which may concern the
quality of the product. The independence of Quality Control from production is
considered fundamental to the satisfactory operation of Quality Control.
39.
Each holder of a manufacturing 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. Adequate resources must be available to ensure that all
the quality control arrangements are effectively and reliably carried out. Presentation
attached at Annex-XIV.
Method Validation
40.
Dr. Farzad Kobarfard, in his presentation underscored the importance and
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 performance
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
8
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,
linearity and range, specificity, reproducibility, robustness were discussed in the
presentation. Some common perceptions of validation were highlighted. Presentation
attached at Annex-XV.
Third Day
21st July 2010
Medical Biotechnology Trends
42.
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. Healthcare 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.
43.
Worldwide, the pharmaceutical market 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 product 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 falling 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 dramatically. Finally, business models would be radically different.
Presentation attached at Annex-XVI.
Quality control of Blood Products
44.
Dr. Siamac Samiee made a presentation on this subject. He said that blood and
blood products, as an essential part 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 Organization (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 blood only from voluntary non-remunerated donors from
low-risk populations.
9
-
-
The screening of all donated blood for transfusion-transmissible infections,
and good laboratory practice in all aspects of blood grouping, compatibility
testing, component preparation 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)
45.
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
46.
Dr. Mojgan Taghizadeh made a presentation on the topic. She said that Vaccines
need to 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
role 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 final
container meets specifications given in market authorization. She also elaborated the
retest policy and identification methods which are:
-
Immunochemical methods are based on the selective, reversible and non-covalent
cbinding 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 tests performed 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-XVIII.
10
Quality Control of Genetically Modified Organisms Products
47.
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, Canada, 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 modification 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 changes 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-XIX.
Quality Control of Recombinant Proteins
48.
Dr. 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 requires 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 specifications for biological/ biotechnologist products should be established
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 representative of
the lot as a whole.
49.
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 changes. 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 product 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 AnnexXX.
Visit to Jaber Ebne Hayyan 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 prospects of
company as well as organizational chart was given by Dr. Montaseri, managing director
of the company. The Company was established in 1960 with the name of Squibb Iran,
11
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 pipeline) 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 million vials.
51.
Dr. Montaseri 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 4th largest pharmaceutical company of total 80 pharmaceuticals 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.
52.
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.
22nd July 2010
Visit to Pasteur Institute of Iran
53.
A visit to the Production & Research Complex (Karaj) of the Pasteur Institute of
Iran was arranged on Thursday, 22nd 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 Institute. 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 on infection disease. Since 1983 the Institute is
offering wide range of teaching activities in the area of pharmaceutical biotechnology at
Ph.D level. The major products at the Institute, among others, are Hepatitis B Vaccine
and BCG Vaccine. This Institute is the only manufacturing unit of Hepatitis B Vaccine in
the Middle East and 7th in the world.
54.
Escorted by Dr. Daryoush Norouzian, Production Director of the Institute, the
participants got the opportunity to witness the process of formulation, filling 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 Mycoplasma, Environmental Monitoring
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
Institute. A working lunch was also arranged.
55.
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
12
museums as well as traditional restaurant and coffee shops. The participants were happy
to visit this complex.
56.
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 Mr. 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.
13