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
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    HANDBOOK

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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

TRS 961 (2011) - Annex 6 - WHO GMP for sterile pharmaceutical products

31/07/2015 | 3139

GMP WHO cho dược phẩm vô trùng/WHO GMP for sterile pharmaceutical products