Евразийская Академия
надлежащих практик
При поддержке:
Министерство промышленности и торговли Российской Федерации Евразийский экономический союз (ЕАЭС) ФБУ «ГИЛС и НП» ООО «СКОПИНФАРМ»

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  • Об Академии
    • Презентация Академии
    • Структура
    • Команда
    • Партнёры
    • Новости и события
    • Нормативные документы
    • Контакты
  • Образовательная деятельность
    • Образовательные программы (план)
    • Слушателю
    • Учебно-методические и библиотечные системы
  • Научное консультирование
    • Научно-экспертный центр по разработке и регистрации лекарственных средств
    • Экспертно-консультационный центр по развитию фармацевтического бизнеса
    • Центр правовой экспертизы и консалтинга
    • Научный центр обеспечения доступности лекарственных препаратов
  • Экспертная деятельность
    • Об Экспертном совете
    • Состав Экспертного совета
  • Мероприятия Академии
    • GxP-Фест
    • GxP-Профи
    • Медиа-материалы
Главная Учебно-методические и библиотечные системы
  • EMA
    CPMPICH273899 NOTE FOR GUIDANCE ON IMPURITIES IN NEW DRUG PRODUCTS.pdf
    CPMPQWP05498 Corr DECISION TREES FOR THE SELECTION OF STERILISATION METHODS.pdf
    CPMPQWP60996Rev 2 DECLARATION OF STORAGE CONDITIONS IN THE PRODUCT INFORMATION OF MEDICINAL PRODUCTS.pdf
    EMA5724542014 Rev 17 Compilation of Community Procedures on Inspections and Exchange of Information.pdf
    EMA6039052013 Questions and answers on Design Space Verification.pdf
    EMACHMPCVMPQWPBWP702782012-Rev1 Guideline on process validation.pdf
    EMACHMPCVMPQWPBWP8503742015 Guideline on the sterilisation of the medicinal product, 7 active substance, excipient and primary container.pdf
    EMAINSGMP3212522012 Rev 15 Compilation of Community Procedures on Inspections.pdf
    WATER FOR PHARMACEUTICAL USE.pdf
  • FDA
    Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations.pdf
    GUIDE TO INSPECTIONS OF QUALITY SYSTEMS.pdf
    Sterile Drug Products Produced by Aseptic Processing —Current Good Manufacturing Practice.pdf
    Analytical Procedures and Methods Validation for Drugs and Biologics.pdf
  • ICH
    • Q1 Изучение стабильности
      Q1A STABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS.pdf
      Q1B PHOTOSTABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS.pdf
      Q1C Annex to the ICH Harmonised Tripartite Guideline on Stability Testing for New Drugs and Products.pdf
      Q1D BRACKETING AND MATRIXING DESIGNS FOR STABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS.pdf
      Q1E EVALUATION FOR STABILITY DATA.pdf
    • Q10 Фармацевтическая система качества
      Q10 PHARMACEUTICAL QUALITY SYSTEM.pdf
    • Q11 Разработка и производство активных фармацевтических субстанций
      Q11 DEVELOPMENT AND MANUFACTURE OF DRUG SUBSTANCES (CHEMICAL ENTITIES AND BIOTECHNOLOGICALBIOLOGICAL ENTITIES).pdf
    • Q12 Управление жизненным циклом лекарственных препаратов
      Q12_Annexes.pdf
      Q12_TECHNICAL AND REGULATORY CONSIDERATIONS FOR PHARMACEUTICAL PRODUCT LIFECYCLE MANAGEMENT.pdf
    • Q2 Валидация аналитических методик
      Q2(R1) VALIDATION OF ANALYTICAL PROCEDURES TEXT AND METHODOLOGY.pdf
    • Q3 Примеси
      Q3A(R2) IMPURITIES IN NEW DRUG SUBSTANCES.pdf
      Q3B(R2) IMPURITIES IN NEW DRUG PRODUCTS.pdf
      Q3C-R6 IMPURITIES GUIDELINE FOR RESIDUAL SOLVENTS.pdf
      Q3C-R8_IMPURITIES GUIDELINE FOR RESIDUAL SOLVENTS_проект.pdf
      Q3D-R1EWG_GUIDELINE FOR ELEMENTAL IMPURITIES.pdf
      Q3D-R2_Step2_GUIDELINE FOR ELEMENTAL IMPURITIES_проект.pdf
    • Q4 Фармакопеи
      Q4B EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL TEXTS FOR USE IN THE ICH REGIONS.pdf
      Q4B Annex 1(R1) RESIDUE ON IGNITIONSULPHATED ASH GENERAL CHAPTER.pdf
      Q4B Annex 2(R1) TEST FOR EXTRACTABLE VOLUME OF PARENTERAL PREPARATIONS GENERAL CHAPTER.pdf
      Q4B Annex 3(R1) TEST FOR PARTICULATE CONTAMINATION SUB-VISIBLE PARTICLES GENERAL CHAPTER.pdf
      Q4B Annex 5(R1) DISINTEGRATION TEST GENERAL CHAPTER.pdf
      Q4B Annex 6 UNIFORMITY OF DOSAGE UNITS GENERAL CHAPTER.pdf
      Q4B Annex 7 (R2) DISSOLUTION TEST GENERAL CHAPTER.pdf
      Q4B Annex 8(R1) STERILITY TEST GENERAL CHAPTER.pdf
      Q4B Annex 9(R1) TABLET FRIABILITY GENERAL CHAPTER.pdf
      Q4B Annex 10(R1) POLYACRYLAMIDE GEL ELECTROPHORESIS GENERAL CHAPTER.pdf
      Q4B Annex 11 CAPILLARY ELECTROPHORESIS GENERAL CHAPTER.pdf
      Q4B Annex 12 ANALYTICAL SIEVING GENERAL CHAPTER.pdf
      Q4B Annex 13 BULK DENSITY AND TAPPED DENSITY OF POWDERS GENERAL CHAPTER.pdf
      Q4B Annex 14 BACTERIAL ENDOTOXINS TEST GENERAL CHAPTER.pdf
      Q4B Annex4A(R1) MICROBIOLOGICAL EXAMINATION OF NON-STERILE PRODUCTS_MICROBIAL ENUMERATIONS TESTS GENERAL CHAPTER.pdf
      Q4B Annex4B(R1) MICROBIOLOGICAL EXAMINATION OF NON-STERILE PRODUCTS TEST FOR SPECIFIED MICRO-ORGANISMS GENERAL CHAPTER.pdf
      Q4B Annex4C(R1) MICROBIOLOGICAL EXAMINATION OF NON-STERILE PRODUCTS ACCEPTANCE CRITERIA FOR PHARMACEUTICAL PREPARATIONS AND SUBSTANCES FOR PHARMACEUTICAL USE GENERAL.pdf
    • Q5 Качество биотехнологической продукции
      Q5A(R1) VIRAL SAFETY EVALUATION OF BIOTECHNOLOGY PRODUCTS DERIVED FROM CELL LINES OF HUMAN OR ANIMAL ORIGIN.pdf
      Q5B QUALITY OF BIOTECHNOLOGICAL PRODUCTS ANALYSIS OF THE EXPRESSION CONSTRUCT IN CELLS USED FOR PRODUCTION OF R-DNA DERIVED PROTEIN PRODUC.pdf
      Q5C STABILITY TESTING OF BIOTECHNOLOGICALBIOLOGICAL PRODUCTS.pdf
      Q5D DERIVATION AND CHARACTERISATION OF CELL SUBSTRATES USED FOR PRODUCTION OF BIOTECHNOLOGICALBIOLOGICAL PRODUCTS.pdf
      Q5E COMPARABILITY OF BIOTECHNOLOGICALBIOLOGICAL PRODUCTS SUBJECT TO CHANGES IN THEIR MANUFACTURING PROCESS.pdf
    • Q6 Спецификации
      Q6A SPECIFICATIONS TEST PROCEDURES AND ACCEPTANCE CRITERIA FOR NEW DRUG SUBSTANCES AND NEW DRUG PRODUCTS CHEMICAL SUBSTANCES.pdf
      Q6B SPECIFICATIONS TEST PROCEDURES AND ACCEPTANCE CRITERIA FOR BIOTECHNOLOGICAL_BIOLOGICAL PRODUCTS.pdf
    • Q7 Надлежащая производственная практика
      Q7 GOOD MANUFACTURING PRACTICE GUIDE FOR ACTIVE PHARMACEUTICAL INGREDIENTS.pdf
    • Q8 Фармацевтическая разработка
      Q8(R2) PHARMACEUTICAL DEVELOPMENT.pdf
    • Q9 Управление рисками для качества
      Q9 QUALITY RISK MANAGEMENT.pdf
  • PIC/S
    • Документы для инспекторатов
      PI 002-3 QUALITY SYSTEM REQUIREMENTS FOR PHARMACEUTICAL INSPECTORATES.pdf
      PI 010-5 PROCEDURE FOR HANDLING RAPID ALERTS AND RECALLS ARISING FROM QUALITY DEFECTS.pdf
      PI 013-3 PICS INSPECTION REPORT FORMAT.pdf
      PI 031-1 TEAM INSPECTIONS.pdf
      PI 039-1 PROCEDURE TO INFORM FOREIGN REGULATORY AGENCIES OF FOREIGN INSPECTIONS TO BE CONDUCTED IN THEIR JURISDICTION.pdf
      PI 048-1 GMP INSPECTION RELIANCE.pdf
      PIC S 1 95 (Rev. 6) PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME.pdf
      PS W 01 2011 QUESTIONNAIRE FOR COMPETENT AUTHORITIES TO BE USED FOR ASSESSMENT, REASSESSMENT AND SELF-EVALUATION.pdf
      PSW 1_2005 (Rev. 2) REVISED PICS AUDIT CHECKLIST.pdf
      PSW 12_2019 GUIDELINES FOR THE PRE-ACCESSION PROCEDURE.pdf
      PSW 14_2011 (Rev. 2) GUIDELINES FOR ACCESSION.pdf
      PSW 31_019 PICS AUDIT CHECKLIST - INTERPRETATION GUIDE.pdf
    • Документы для инспекторов
      PE 005-3 PICS GMP GUIDE FOR BLOOD ESTABLISHMENTS.pdf
      PE 010-4 PICS GUIDE TO GOOD PRACTICES FOR THE PREPARATION OF MEDICINAL PRODUCTS IN HEALTHCARE ESTABLISHMENTS.pdf
      PE 011-1 PICS GUIDE TO GOOD DISTRIBUTION PRACTICE FOR MEDICINAL PRODUCTS.pdf
      PI 005-3 GUIDANCE ON PARAMETRIC RELEASE.pdf
      PI 006-3 VALIDATION MASTER PLAN INSTALLATION AND OPERATIONAL QUALIFICATION NON-STERILE PROCESS VALIDATION CLEANING VALIDATION.pdf
      PI 007-6 VALIDATION OF ASEPTIC PROCESSES.pdf
      PI 008 – 3 PICS GUIDE TO INSPECTIONS OF SOURCE PLASMA ESTABLISHMENTS AND PLASMA WAREHOUSES (INSPECTION GUIDE).pdf
      PI 009-4 INSPECTION OF UTILITIES.pdf
      PI 011-3 GOOD PRACTICES FOR COMPUTERISED SYSTEMS IN REGULATED “GXP” ENVIRONMENTS.pdf
      PI 012-3 STERILITY TESTING.pdf
      PI 014-3 ISOLATORS USED FOR ASEPTIC PROCESSING AND STERILITY TESTING.pdf
      PI 021-2 GMP PARTICULARITIES IN THE MANUFACTURE OF MEDICINAL PRODUCTS TO BE USED IN CLINICAL TRIALS ON HUMAN SUBJECTS.pdf
      PI 023–2 INSPECTION OF PHARMACEUTICAL QUALITY CONTROL LABORATORIES.pdf
      PI 024-3 INSPECTION OF BIOTECHNOLOGY MANUFACTURES.pdf
      PI 025-2 INSPECTION OF MEDICINAL GASES.pdf
      PI 026-2 QUALIFICATION AND TRAINING OF INSPECTORS IN THE FIELD OF HUMAN BLOOD, TISSUES AND CELLS.pdf
      PI 028-2 GMP INSPECTION RELATED TO PACKAGING.pdf
      PI 030-1 INSPECTION OF ACTIVE PHARMACEUTICAL INGREDIENTS.pdf
      PI 032-2 GMP ANNEX 1 REVISION 2008, INTERPRETATION OF MOST IMPORTANT CHANGES FOR THE MANUFACTURE OF STERILE MEDICINAL PRODUCTS.pdf
      PI 037-1 A RECOMMENDED MODEL FOR RISK-BASED INSPECTION PLANNING IN THE GMP ENVIRONMENT.pdf
      PI 038-2 ASSESSMENT OF QUALITY RISK MANAGEMENT IMPLEMENTATION.pdf
      PI 040-1 PICS GUIDANCE ON CLASSIFICATION OF GMP DEFICIENCIES.pdf
      PI 041-1 (Draft 3) GOOD PRACTICES FOR DATA MANAGEMENT AND INTEGRITY IN REGULATED GMPGDP ENVIRONMENTS.pdf
      PI 043-1 CROSS-CONTAMINATION IN SHARED FACILITIES.pdf
      PI 045-1 GUIDELINES ON THE FORMALISED RISK ASSESSMENT FOR ASCERTAINING THE APPROPRIATE GOOD MANUFACTURING PRACTICE FOR EXCIPIENTS.pdf
      PI 046-1 GUIDELINE ON SETTING HEALTH BASED EXPOSURE LIMITS FOR USE IN RISK IDENTIFICATION IN THE MANUFACTURE OF DIFFERENT MEDICINALPRODUCTS.pdf
      PI 047-1 GUIDELINES ON THE PRINCIPLES OF GDP OF ACTIVE SUBSTANCES.pdf
      PI 052-1 INSPECTION OF HEALTH BASED EXPOSURE LIMIT (HBEL) ASSESSMENTS AND USE IN QUALITY RISK MANAGEMENT.pdf
      PI 053-1 QUESTIONS AND ANSWERS ON IMPLEMENTATION OF RISK-BASED PREVENTION OF CROSS-CONTAMINATION IN PRODUCTION.pdf
      PI 054-1 (Draft 1) How to Evaluate Demonstrate the Effectiveness of a Pharmaceutical Quality System in relation to Risk-based Change Management.pdf
      PS INF 6 2012 (Rev. 1) QUESTIONS AND ANSWERS ON TRACEABILITY OF MEDICINAL GASES.pdf
      PS INF 20 2011 Questions & Answers document regarding Distribution Activities for Active Pharmaceutical Ingredients (APIs).pdf
      PS INF 88 2019 Concept Note on a Document prepared by the PICS QRM Expert Circle on‘How to Evaluate Demonstrate the Effectiveness of a PQS.pdf
    • Документы для промышленности
      Annex 1 Manufacture of Sterile Products_проект.pdf
      Annex 2A Manufacture of Advanced Therapy Medicinal Products for Human Use_проект.pdf
      PE 008-4 EXPLANATORY NOTES FOR PHARMACEUTICAL MANUFACTURERSON THE PREPARATION OF A SITE MASTER FILE.pdf
      PI 019–3 SITE MASTER FILE FOR SOURCE PLASMA ESTABLISHMENTS.pdf
      PI 020-3 SITE MASTER FILE FOR PLASMA WAREHOUSES.pdf
      PS INF 26 2019 (Rev. 1) Annex 2B Manufacture of biological medicinal substances and products for human use_проект.pdf
    • Правила надлежащей производственной практики PICS
      1. PE 009-14 (Intro) GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS.pdf
      2. PE 009-14 (Part I) GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS.pdf
      3. PE 009-14 (Part II) GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS.pdf
      4. PE 009-14 (Annexes).pdf
  • WHO
    • GMP WHO
      GMP for biological products.pdf
      GMP WHO.pdf
      GMP_For_Biologicals_NEW-2016.pdf
      GMPActivePharmaceuticalIngredients.pdf
      GMPBiologicalProductsTRS822Annex3.pdf
      GMPBloodEstablishments.pdf
      GMPPharmaceuticalProductsCcontainingHhazardousSubstancesTRS957Annex3.pdf
      GMPRadiopharmaceuticalProductsTRS908Annex3.pdf
      GMPSterilePharmaceuticalProductsTRS961Annex6.pdf
      Guidelines on good manufacturing practices validation.pdf
      HAACP.pdf
      InvestigationalPharmaceuticalProductsClinicalTrialsHumansTRS863Annex7.pdf
      Supplementary guidelines on good manufacturing non-sterile.pdf
      Supplementary guidelines on good manufacturing.pdf
      SupplementaryGMPManufactureHerbalMedicinesTRS937Annex3.pdf
      SupplementaryGMPPharmaceuticalExcipients.pdf
      WHO good manufacturing practices water.pdf
    • Vaccines
      Annex_3_WHO_TRS_962-3.pdf
      batch release.pdf
      Changes.pdf
      interferons.pdf
      recombinant inteferons.pdf
      Recommendations for the evaluation of animal cell cultures .pdf
      thiomersal.pdf
      TRS_978_Annex_3 Recommendations for the evaluation of animal cell cultures.pdf
      WHO_TRS_530_A4.pdf
      WHO_TRS_822.pdf
      WHO_TRS_927 (Informe 54).pdf
      WHO_TRS_977 (Informe 60).pdf
      Yellow fever.pdf
    • Всемирная организация здравоохранения WHO
      • Взаимозаменяемость
        AdditionalGuidanceOrganizationPerformInvivoBioequivalenceStudiesTRS937Annex9.pdf
        Annex7-TRS992.pdf
        Annex8-TRS992.pdf
        GuidanceSelectionComparatorPharmaceuticalProductsEquivalenceAssessmentInterchangeableMultisourceProductsTRS902Annex11.pdf
        ProposalWaiveVivoBioequivalenceRequirementsModelListEssentialMedicinesImmediateReleaseSolidOralDosageFormsTRS937Annex8.pdf
      • Дистрибуция
        FIPWHOGuidelinesGoodPharmacyPracticeTRS961Annex8.pdf
        • Готовые продукты
          GoodDistributionPracticesTRS957Annex5.pdf
          GuidelinesImportProceduresPharmaceuticalProductsTRS863Annex12.pdf
        • Закупки
          GuidelinesForPreparationProcurementAgencyFileTRS917Annex7.pdf
          GuidelinesOnRequalificationTRS957Annex6.pdf
          ProcedureForAssessingAcceptabilityProcurementAgenciesUN_TRS917Annex6.pdf
          TRS986annex3.pdf
          TRS986annex4.pdf
        • Исходные материалы
          GoodtradeDistributionPracticesTRS917Annex2.pdf
          PharmaceuticalStartingMaterialsCertificationSchemeTRS917Annex3.pdf
        • Технические приложения
          introduction.pdf
          introduction_v2.pdf
          supplement_1_Selecting_sites_for_storage.pdf
          supplement_2_Design_and_procurement_of_storage_facilities.pdf
          supplement_3_Estimating_the_capacity_of_storage_facilities.pdf
          supplement_4_Building_security_and_fire_protection.pdf
          supplement_5_Maintenance_of_storage_facilities.pdf
          supplement_6_Temperature_and_humidity_monitoring_systems_for_fixed_storage_areas.pdf
          supplement_7_Qualification_of_temperature-controlled_storage_areas.pdf
          supplement_8_Temperature_mapping_of_storage_areas.pdf
          supplement_9_Maintenance_of_refrigeration_equipment.pdf
          supplement_10_Checking_the_accuracy_of_temperature_control_and_monitoring_devices.pdf
          supplement_11_Qualification_of_refrigerated.pdf
          supplement_12_Temperature-controlled_transport_operations_by_road and by air.pdf
          supplement_13_Qualification_of_shipping_containers.pdf
          supplement_14_Transport_route_profiling_qualification.pdf
          supplement_15_Temperature_and_humidity_monitoring_systems_for_transport_operations.pdf
          supplement_16_Environmental_management_of refrigeration equipment.pdf
        • Хранение
          Annex5-TRS992.pdf
          GuideGoodStoragePracticesTRS908Annex9.pdf
          ModelGuidanceForStorageTransportTRS961Annex9.pdf
      • Инспекция
        Annex2_TRS823_Inspection_Pharmaceutical_Manufacturers.pdf
        Annex4-TRS992_General_guidance_on_hold_time_studies.pdf
        Annex5_TRS908_Model_Certificate_GMP.pdf
        Annex6_TRS885_Inspection_Drug_Distribution_Channels.pdf
        Annex7_TRS902_Preapproval_Inspections.pdf
        Annex8_TRS902_Quality_System_Requirements_National_GMP_Inspectorates.pdf
        Annex14_TRS961_Guidelines_Drafting_Site_Master_File.pdf
        GuidanceGMPInspectionReportTRS908Annex6.pdf
      • Контроль_качества
        9241545135.pdf
        Annex1TRS-981.pdf
        Annex1-TRS992.pdf
        ConsiderationsRequestingAnalysesDrugSamplesTRS902Annex4.pdf
        GeneralGuidelinesEstablishmentMaintenanceDistributionChemicaReferenceSubstancesTRS943Annex3.pdf
        GoodPracticesPharmaceuticalMicrobiologyLaboratoriesTRS961Annex2.pdf
        GoodpracticesPharmaceuticalQualityControlLaboratoriesTRS957Annex1.pdf
        GuidelinesPreparingLaboratoryInformationFileTRS961Annex13.pdf
        ModelCertificateAnalysisTRS902Annex10.pdf
        PrequalificationQualityControlLaboratoriesProcedureAssessingAcceptabilityUseUNAgenciesTRS961Annex12.pdf
        RecommendationsRiskTransmittingAnimalSpongiformEncephalopathyAgentsViaMedicinalProductsTRS908Annex1.pdf
      • Преквалификация
        Annex3TRS-981.pdf
        Annex4TRS-970.pdf
        Annex4TRS-981.pdf
        GuidanceVariationSprequalifiedProductDossierTRS943Annex6.pdf
        GuidelinesOnRequalificationPrequalifiedTRS957Annex6.pdf
        GuidelinesSubmissionDocumentationPrequalificationInnovatorFinishedPharmProductsApprovedStringentRegulatoryAuthoritiesTRS961Annex11.pdf
        PrequalificationQualityControlLaboratoriesProcedureAssessingAcceptabilityTRS961Annex12.pdf
        TRS961_Annex10.pdf
        TRS986annex5.pdf
      • Производство
        • GMP
          Annex3-TRS992.pdf
          GMPActivePharmaceuticalIngredientsTRS957Annex2.pdf
          GMPBiologicalProductsTRS822Annex3.pdf
          GMPBloodEstablishmentsTRS961Annex4.pdf
          GMPPharmaceuticalProductsCcontainingHhazardousSubstancesTRS957Annex3.pdf
          GMPRadiopharmaceuticalProductsTRS908Annex3.pdf
          GMPSterilePharmaceuticalProductsTRS961Annex6.pdf
          GMPWatePharmaceuticalUseTRS970Annex2.pdf
          InvestigationalPharmaceuticalProductsClinicalTrialsHumansTRS863Annex7.pdf
          SupplementaryGMPHeatingVentilationAirconditioningSystemsNonSterilePharmaceuticalDosageFormsTRS961Annex5.pdf
          SupplementaryGMPManufactureHerbalMedicinesTRS937Annex3.pdf
          SupplementaryGMPPharmaceuticalExcipientsTRS885Annex5.pdf
          SupplementaryGMPValidationTRS937Annex4.pdf
          TRS986annex2.pdf
        • Анализ рисков
          ApplicationHACCPMethodologyPharmaceuticalsTRS908Annex7.pdf
        • Трансфер технологий
          TransferTechnologyPharmaceuticalManufacturingTRS961Annex7.pdf
      • Стабильность
        RAJ2006WHOStability.pdf
        StabilityConditionsTable2UupdatedMarch2015.pdf
        WHO_EXPERT_COMMITTEE_ON_SPECIFICATIONS_FOR_PHARMACEUTICAL_PREPARATIONS.pdf
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