Transcript State Veterinary Drug Quality Control Laboratory

State Veterinary Drug
Quality Control Laboratory
/Accreditation Laboratory/
Uuganbayar, Dorjbat
Brief introduction of SVDQCL
• SVDQCL stands for State Veterinary Drug
Quality Control Laboratory and it was first
established in 1973
• At that time it was controlling the quality of
only vaccination which was produced by the
domestic producer Bio-combinat.
Brief introduction of SVDQCL
• In 1990 mongolia shifted to a market economy
system; regurding this drug producting and
importing have beenrapidly developing until
today. Therefore, the operations and scope of
SVDQCL is also broadening.
• SVDQCLis a government owned organization
that has the right of doing tests on drugs,
biopreparation, and medical raw materials, and
certify ther on beholf of the state.
• There is a Certification Unit in SVDQCL and that
does conformation assessment.
Goal
To introduce quality system in production of
medicine and drugs produced in Mongolia
and imported into the country, to manage
professional service in implementation of
strategy in the sector with high quality biopreparations.
Activities
•To test and certify drugs preparation, bio- preparations
registered by the drug registration list of Mongolia and
suggested ones;
•To manage monitoring service for enterprises and grant
certificates to tested products;
•To introduce quality system into animal drug production
and its importation;
•To set national standard related to certification of animal
drugs and make it closer to international level;
•To expand foreign relations and technique and
technology;
Our Team
• We have 35 staff totally working
together (DVMS, Chemists, biotechnologists and pharmacists)
• 65 percent of laboratory staff has higher
education
•Ph.doctor-1,
doctoral
master-6, postgraduate-5
candidate-2,
SVDQCL Certification
•The Testing laboratory of SVDQCL met the
standard of MNS/ISO 17025 and got certified by
the National Center for Standardization and
meteorology in 2004, 2007 and 2009
•The Certification Unit of SVDQCL met the
standard of MNS/ISO/IEC Guide 65-2004 and got
certified by the
national center for
Standardization and meteorology in 2004, 2007
and 2009
The Internal structure of SVDQCL
Administration
Certification Unit
Testing laboratory
Strain Fund
laboratory
Virusology
laboratory
Bacteriology
laboratory
Chemical
laboratory
The Certification
Unit Courcil
External structure of SVDQCL
The Ministry of Food and Agriculture and
Light industry-The Department of
Veterinary Service
The General Inspection
agency
Drug
producer
SVDQCL
Drug importer
The national Center for
standardization and
metrology
Drug Research
organization
Local authority and regulations related to the
veterinary medicine management and quality
control
•MNS ISO/IEC7025:2007
•MNS ISO/TR
10013:2001
•MNS ISO 8402:97
•MNS ISO 9000:2001
•MNS ISO 9001:2001
•MNS ISO/IEC Guide
65:2003
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Pharmacopeia of:
USA
China
Russia
British
National standard
SOP
Livestock Statistics and its latest
condition
Total animal amount
Name of
№
animals
/thousand/
2009/2008
2008
2009
Difference
Precent
(%)
1.
Camel
266.4
275.1
8.6
103.2
2.
Horse
2186.9
2206.7
19.8
100.9
3.
Cattle
2503.4
2579.9
76.2
103.0
4.
Sheep
18362.3
19125.2
762.9
104.0
5.
Goat
19969.4
19470.5
498.9
97.5
Total
43288.5
43657.1
368.6
100.9
Introduction of animal health products
industry
•The veterinary manufacture was first founded in
MGL in 1923.
•In 1973, Bio-combinate was established by the
investment of The Republic of Hungary to produce
vaccines, serum and diagnostic tests for the
prevention of contagious diseases.
•At the present the Bio-combinate has become one
of the biggest manufacturers that produces 26
different types of vaccines, 6 serum and 24
diagnostic tests.
Introduction of animal health products
industry
• There more drug factories have been
established that produce
antiparasitic
drugs because parasitic diseases are quite
common in our country.
• There have been more and more
manufacturers established that produce
commonly used drugs.
Number of manufacturers,
importers
7 Drug manufacturers and 38
Drug importers in Mongolia.
Chart of top companies especially
domestic importers
1.Mongolia V.E.T.NET NGO
2.Monvetmed LLC
3.Global Business Link LLC
4.Sorlog sureg LLC
5.UNN LLC
Number of registered
products
Over 370 drugs have been registered in the
veterinary drug registration of Mongolia.
Those are:
Antibiotics-80
Vaccines-54
Parasitic drugs-56
Others-180
The state veterinary drug registration does not
register botanical and traditional drugs but our
laboratory tests these drugs.
The number of batches tested last 3
years
2008
№ Name of products
2009
2010
Type
Batch
1. Antibiotics
19
45
17
21
14
21
2. Vaccines
37
187
38
153
23
126
Ectoparasiticides
9
13
3
3
6
7
Endectocides
12
25
12
25
9
23
Endo and
ectoctoparasiticides
26
38
19
30
12
28
4. Other
95
159
109
173
91
137
5. Total
198
467
198 405 155
3. Parasitis
6. Company
31
Type Batch Type
28
Batch
342
33
Unfortunately, we do not have the information about the sales amount of the drugs.
Sales amount and list of high ranking
products by their types
1. The government of MGL funds 100% percent for
manufacturing of the contagious disease
prevention vaccines and provides them to
numbers 70% of total livestock of MGL is
vaccinated with those vaccines. Therefore,
vaccine sale is the highest.
2. Anti-parasitic drugs
3. Antibiotics
Highlighted issues of Animal health
product market
•It is likely to have issues of fake drug
production and importation
•We need to train our human resource.
•We also need to improve our equipments and
technology
The approval process of animal
health product
Requirements:
•The manufacturer should have GMP or ISO
international standard certification.
•The accredited lab result of the manufacturer.
•Published material about pharmacological and clinical
trials.
•Registrations in not less than 3 countries.
•Approved instruction that includes the drug
ingredients, chemistry, usage, precautions, side effects,
drug interactions, storage, warnings etc.
•Drug sample for a test.
•Methods and methodology to test
The approval process of animal health
product
•Analysis certificate
•The manufacturer introduction.
•Standard references indicated in testing methods.
•Every manufacturer has its internal, control lab. We
require the result of that lab. Additionally, the result of
the accredited lab.
• We try to pursue the methods, methodology, and
standard used in countries such as USA although we
have the pharmacopeia of the same country. Because
the result can be various if we test with such
pharmacopeia depending on the testing method,
technology, substance, and reagent. For this reason
we require the approved standard method of analysis
which is pursued in that present country.
The approval process of animal health
product
Registration fee:
The client is responsible for the cost of drug registration.
The fee is constituted
•Registration procedure
•Test and certification
The fee:
•May be various depending on drug type and testing
period.
•We are changing the fee so far. That is why it is not
possible to inform the realistic amount now.
The approval process of animal health
product
Duration for getting approval:
The test is performed within approximately duration of 7-30
days after the submission of medicine product registration
request.
The Veterinary Drug Committee should make its decision
within 21 days after the test result come out.
The state registration certificate should be given within 14 days
after the decision of the veterinary committee.
The state registration certificate is given for the period of 5
years.
The approval process of animal
health product
Renewal:
Shall renew the national registration in the
following condition:
1. If drug industry governance, name and address
were changed
2. If drug standards were changed
The approval process of
animal health product
Registration period:
Notify the expiration date of certain drugs prior
to 3 months then it’ll be reregistered.
The approval process of feed and
feed additive
•There is no article in the law at this moment about how to
register the feed and feed additives in the drug
registration.
•If anyone wants to import the feed and feed additives, the
same documents requested for the drug registration is also
needed, even those feed and feed additives are not
required to be registered in the drug registration. And
those feed and feed additives are supplied to the market
after inspection of State Veterinary Drug Quality Control
Laboratory.
Quality Management System
Strategy:
Approve drugs that provided quality, active and
safe for environment, animal and human by
testing as using appropriate methods according to
standard of veterinary practice of Mongolia.
Purpose:
1. Must be provided by accommodation and
environmental
condition,
human
factors,
equipment, reagent, animals and method analysis.
2. To have quality manual to approve testing process
and principles
3. Basis of the testing process and result must be
independence
from other factors including
administers and finances.
4. Testing result must be reliable and complete.
5. Laboratory must have International and National
standards, Reference materials and Reference
standards.
Quality Management System
Quality manual-1
(Level А)
Principles-60
(Level B)
SOP (Level C)-77
Laboratory record
(Level D)-177
Thank you very much
Phone: (976)-(11)- 99061455
Email: [email protected]