GMPc Vietnam JSC
  • About Us  
    • Summary information
    • Key Personnel
  • Services  
    • WHO GMP Pharmaceutical facilities  
      • Project feasibility study
      • Technology and Equipment consultation
      • Detail Construction and MEP drawing
      • Project Management and Supervision
      • WHO GMP Training and Guidance
      • Preparation of WHO GMP registration dossier
      • WHO GMP Re-evaluation consultation
    • EU GMP Pharmaceutical Factory  
      • Feasibility study report
      • Design detailed construction drawings
      • QM documentation – Validation
      • GMP application and product dossier application
      • Project management - Construction supervision
    • CGMP, ISO 22716-certified cosmetics facilities  
      • Project feasibility study
      • Technology and Equipment consultation
      • Detail Construction and MEP drawing
      • Project Management and Supervision
      • CGMP ASEAN Training and Guidance
      • Preparation of CGMP ASEAN/ ISO 22716 registration dossier
      • CGMP ASEAN Re-evaluation consultation
    • Health-supplement facilities  
      • Project feasibility study
      • Technology and Equipment consultation
      • Detail Construction and MEP drawing
      • Project Management and Supervision
      • HS GMP Training and Guidance
      • Preparation HS GMP registration dossier
      • HS GMP - Re-evaluation consultation
    • Eligibility For Cosmetic Manufacturing  
      • Overall consultation
      • Detail Construction and MEP drawing
      • Designing, Constructing, Ensured Certification
      • Preparation of Registration Dossier
    • Pharmaceutical distribution center  
      • Feasibility Study
      • Design and Information Technology Solutions
      • Project Management and Supervision
      • GSP registration and operation consultancy
    • GSP warehouses  
      • Project feasibility study
      • Detail Construction and MEP drawing
      • GSP Training and Guidance
      • Overall Consultation on Designing And Constructing
      • GSP Re-evaluation consultation
    • Veterinary Pharmaceutical Facilities  
      • Project Feasibility Study
      • Technology and Equipment consultation
      • Detail Construction and MEP Drawing
      • Project management and Supervision
      • WHO GMP Training and Guidance
      • Preparation of WHO GMP registration dossier
      • WHO GMP Re-evaluation consultation
    • GMP, GLP, GSP training  
      • Basis knowledge
      • Intensive Training
    • Other GPs’s consultation  
      • GLP inspection laboratories
      • GDP distribution systems
      • GPP pharmacy
      • WHO GACP medicinal materials
    • Register and Announce  
      • Announcement of Imported Cosmetic
    • Dairy Factory  
      • Overall Planning
      • Detailed Construction & MEP Design - Project Budgeting
      • Contractor/Supplier Consultation and Project Management
      • Training, Drafting registration dossier
  • Project
  • Video
  • GMP-Handbook
  • Faqs
  • News
  • Jobs
  • Contact

    HANDBOOK

  1. Home
  2. HANDBOOK
  3. Drug Administration of Vietnam & Ministry of Health

List of documents

  • Regulatory documents
    • National Assembly - Government
    • Drug Administration of Vietnam & Ministry of Health
    • Department of Food Administration & Ministry of Health
    • Department of Animal Health & Ministry of Agriculture and Rural Development
  • Regulatory Forms
    • Pharmacy
    • Health Supplement
    • Cosmetic
    • Aquatic Veterinary Medicine
  • GMP/GLP/GSP general guidelines
    • GMP WHO, ASEAN,...
    • PIC/S, ICH, EU GMP,...
    • WHO GSP guidelines
    • GPs guidelines
    • GLP guidelines
  • Advanced GMP/GLP/GSP guidelines
    • Issued by WHO
    • Collected by GMPc
    • Compiled by GMPc
  • HS GMP, CGMP ASEAN documents
    • HS GMP guideline for Health Supplement Manufacture
    • CGMP ASEAN guideline for Cosmetic Manufacture
  • SOP, IQ, OQ, PQ forms
    • SOP - Standard Operating Procedure
    • IQ - Installation Qualification
    • OQ - Operational Qualification
    • PQ - Performance Qualification
    • Other forms-procedures
  • Utility software
    • GMP management software
    • General Utilities
  • Statistics and industry analysis
    • Pharmaceutical industry analysis Data
    • Company Analysis
  • GMPc portfolio

Công văn đình chỉ lưu hành thuốc không đạt tiêu chuẩn chất lượng (12/07/2016)

13/07/2016 | 4100

Cục Quản lý Dược ban hành các công văn đình chỉ lưu hành: Công văn số 11891/QLD-CL ngày 27/6/2016 về việc đình chỉ lưu hành thuốc không đạt tiêu chuẩn...

Cục Quản lý Dược ban hành các công văn đình chỉ lưu hành: Công văn số 11891/QLD-CL ngày 27/6/2016 về việc đình chỉ lưu hành thuốc không đạt tiêu chuẩn về chỉ tiêu Đinh lượng đối với thuốc Bột pha hỗn dịch uống Philtadol (Cefpodoxim 100mg), số lô: 15002, HD: 03/11/2017, SĐK: VD-22044-14 do Công ty TNHH Phil Inter Pharma sản xuất. Công văn số 11892/QLD-CL ngày 27/6/2016 về việc đình chỉ lưu hành trên toàn quốc thuốc không đạt tiêu chuẩn chất lượng về chỉ tiêu Độ hòa tan đối với thuốc viên nén bao phim Rom-150 tablets (Roxithromycin 150mg), số lô: ZET1709, NSX: 22/7/2014, HD: 21/7/2017, SĐK: VN-17178-13 do Công ty Zee Laboratories (India) sản xuất, Công ty TNHH MTV Dược phẩm Trung ương 2 (tên mới là Công ty CPDP Trung ương Coduphar) nhập khẩu. Công văn số 12599/QLD-CL ngày 04/7/2016 về việc đình chỉ lưu hành thuốc không đạt tiêu chuẩn chất lượng về chỉ tiêu Độ hòa tan đối với thuốc Bột pha hỗn dịch uống Ceferaxim 125 (Cefuroxime 125mg), số lô: 173316001, HD: 05/01/2018, SĐK: VN-11733-11 do Công ty Vintanova Pharma Pvt Ltd (India) sản xuất, Công ty CP Dược Đại Nam nhập khẩu
 
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  • GMPc Vietnam JSC
  • Head Office: No. 18, Mang Cam 1 Street, An Lac Green Symphony, Van Canh Ward, Hoai Duc District, Hanoi City
  • Business location : No. 32, Vi Cam 5 Street, An Lac Green Symphony, Van Canh Ward, Hoai Duc District, Hanoi City
  • Tel: 0243.787.2242 | CEO hotline: 0982.866.668
  • Email: contact@gmp.com.vn
  • Representative Office: 156/1/1, Cong Hoa Street - Ward 12 - Tan Binh District - Ho Chi Minh City
  • Tel: 0283.811.7383 
  • Quick link
  • About Us
  • Services
  • Project
  • GMP-Handbook
  • Video
  • Consulting for cosmetic facility
  • Consulting for health supplement facility
  • Consulting for GSP warehouse
  • Fanpage
Facebook

Copyright © 2020 GMPc. All rights reserved.

  • Home
  • About Us
    • Summary information
    • Key Personnel
  • Services
    • WHO GMP Pharmaceutical facilities
      • Project feasibility study
      • Technology and Equipment consultation
      • Detail Construction and MEP drawing
      • Project Management and Supervision
      • WHO GMP Training and Guidance
      • Preparation of WHO GMP registration dossier
      • WHO GMP Re-evaluation consultation
    • EU GMP Pharmaceutical Factory
      • Feasibility study report
      • Design detailed construction drawings
      • QM documentation – Validation
      • GMP application and product dossier application
      • Project management - Construction supervision
    • CGMP, ISO 22716-certified cosmetics facilities
      • Project feasibility study
      • Technology and Equipment consultation
      • Detail Construction and MEP drawing
      • Project Management and Supervision
      • CGMP ASEAN Training and Guidance
      • Preparation of CGMP ASEAN/ ISO 22716 registration dossier
      • CGMP ASEAN Re-evaluation consultation
    • Health-supplement facilities
      • Project feasibility study
      • Technology and Equipment consultation
      • Detail Construction and MEP drawing
      • Project Management and Supervision
      • HS GMP Training and Guidance
      • Preparation HS GMP registration dossier
      • HS GMP - Re-evaluation consultation
    • Eligibility For Cosmetic Manufacturing
      • Overall consultation
      • Detail Construction and MEP drawing
      • Designing, Constructing, Ensured Certification
      • Preparation of Registration Dossier
    • Pharmaceutical distribution center
      • Feasibility Study
      • Design and Information Technology Solutions
      • Project Management and Supervision
      • GSP registration and operation consultancy
    • GSP warehouses
      • Project feasibility study
      • Detail Construction and MEP drawing
      • GSP Training and Guidance
      • Overall Consultation on Designing And Constructing
      • GSP Re-evaluation consultation
    • Veterinary Pharmaceutical Facilities
      • Project Feasibility Study
      • Technology and Equipment consultation
      • Detail Construction and MEP Drawing
      • Project management and Supervision
      • WHO GMP Training and Guidance
      • Preparation of WHO GMP registration dossier
      • WHO GMP Re-evaluation consultation
    • GMP, GLP, GSP training
      • Basis knowledge
      • Intensive Training
    • Other GPs’s consultation
      • GLP inspection laboratories
      • GDP distribution systems
      • GPP pharmacy
      • WHO GACP medicinal materials
    • Register and Announce
      • Announcement of Imported Cosmetic
    • Dairy Factory
      • Overall Planning
      • Detailed Construction & MEP Design - Project Budgeting
      • Contractor/Supplier Consultation and Project Management
      • Training, Drafting registration dossier
  • Project
  • Video
  • GMP-Handbook
  • Faqs
  • News
  • Jobs
  • Contact
 
Hotline: 0982.866.668
Nhắn tin Facebook Zalo: 0982.866.668