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.

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 bio- preparations. Goal

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; Activities

We have 35 staff totally working together (DVMS, Chemists, biotechnologists and pharmacists) 65 percent of laboratory staff has higher education Ph.doctor-1, doctoral candidate-2, master-6, postgraduate-5 Our Team

The Testing laboratory of SVDQCL met the standard of MNS/ISO 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 and got certified by the national center for Standardization and meteorology in 2004, 2007 and 2009 SVDQCL Certification

The Internal structure of SVDQCL Certification Unit The Certification Unit Courcil Testing laboratory Administration Bacteriology laboratory Virusology laboratory Strain Fund laboratory Chemical laboratory

The Ministry of Food and Agriculture and Light industry-The Department of Veterinary Service The Ministry of Food and Agriculture and Light industry-The Department of Veterinary Service The national Center for standardization and metrology Drug Research organization Drug importer Drug producer SVDQCL The General Inspection agency External structure of SVDQCL

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 Local authority and regulations related to the veterinary medicine management and quality control Pharmacopeia of: USA China Russia British National standard SOP

№ Name of animals Total animal amount /thousand/ 2009/ Difference Precent (%) 1.Camel Horse Cattle Sheep Goat Total Livestock Statistics and its latest condition

The veterinary manufacture was first founded in MGL in 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. Introduction of animal health products industry

7 Drug manufacturers and 38 Drug importers in Mongolia. Number of manufacturers, importers

1.Mongolia V.E.T.NET NGO 2.Monvetmed LLC 3.Global Business Link LLC 4.Sorlog sureg LLC 5.UNN LLC Chart of top companies especially domestic importers

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. Number of registered products

№ Name of products TypeBatchTypeBatchTypeBatch 1.Antibiotics Vaccines Parasitis Ectoparasiticides Endectocides Endo and ectoctoparasiticides Other Total Company The number of batches tested last 3 years Unfortunately, we do not have the information about the sales amount of the drugs.

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 Sales amount and list of high ranking products by their types

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 Highlighted issues of Animal health product market

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.

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 animal health product

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. The approval process of feed and feed additive

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 29 Laboratory record (Level D)-177 SOP (Level C)-77 Principles-60 (Level B) Quality manual-1 (Level А)

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