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

    SERVICES

  1. Home
  2. SERVICES
  3. GSP WAREHOUSE

List of services

  • Pharmaceutical Facilities
  • EU GMP Pharmaceutical Factory
  • Health Supplement Facilities
  • CGMP, ISO 22716-certified Cosmetics Facilities
  • Eligibility for cosmetic manufacturing
  • GSP Warehouses
  • Pharmaceutical Distribution Center
  • Dairy Factory
  • GMP, GLP, GSP Training
  • Other GPs’s consultation

Typical projects

Nippon Chemiphar Pharmaceutical Facility - GMP certification

Nippon Chemiphar Pharmaceutical Facility - GMP certification

Hapharco Pharmaceutical Warehouse - GSP certification

Hapharco Pharmaceutical Warehouse - GSP certification

Hau Giang Pharmaceutical Facility - WHO GMP certification

Hau Giang Pharmaceutical Facility - WHO GMP certification

VIMAC Cosmetic Facility - CGMP ASEAN Certification

VIMAC Cosmetic Facility - CGMP ASEAN Certification

GSP Re-evaluation Consultation

23/06/2021 | 2126

“Directly reviewing the overall storage warehouse, planning to overcome the problems, retraining knowledge of GSP, related knowledge and completing the GSP reassessment application as required by the  Authority”

Import-export and storage service establishments that satisfy GSP requirements shall be granted certificates of eligibility for pharmaceutical business in the scope of import and export, and services for preserving drugs and medicinal ingredients. As a rule, the Certificate of Eligibility for Pharmacy and the GSP Warehouse Certificate is valid for 3 years the date of issue, so the establishment should proceed to apply for GSP maintenance reassessment first. When the certificate expires in order for the regulator to set up a mission to the establishment to perform the assessment and re-recertify the GSP to the Preservation warehouse..

GMPc Vietnam's GSP reevaluation consulting service includes 6 steps as follows:

+ Step 1: Overall review

Review the entire warehouse and participate in internal inspection to record the current state of existence

+ Step 2: Make a plan to overcome existing problems

List the work to be performed and the records to be prepared for GSP reassessment

+ Step 3: Re-training knowledge about GSP

Training to repeat the theory, combined with GSP practice guidance at the storage warehouse. Besides, GMPc will update the latest regulations on relevant laws.

+ Step 4: Deploying, supplementing, completing documents to prepare for GSP re-evaluation

All documents in 3 years at the factory include:

  • Correction report of the previous evaluation
  • Legal records
  • Human resource and training records
  • Records storage activities.
  • Document on warehouse cleaning and handling of harmful insects and animals.
  • Warehouse appraisal activities.
  • Import and export of drugs and materials under Special Control (if any)
  • Self-inspection activities of preservation warehouse.

+ Step 5: Submit document to Drug Administration Of Vietnam

Filing for GSP reassessment is the final stage of the preparation for the Establishment to demonstrate to the regulator that within 3 years of obtaining a certificate of eligibility for the import-export pharmacy business. / maintenance services with a GSP certificate, the establishment maintains that it meets the guidelines for the GSP standards and serves as the basis for the regulator to make the decision to set up a reevaluation team for its entity.
+ Step 6: Support when auditing
GMPc accompanies the Unit in welcoming the assessment team to maintain compliance with GSP and continue to support the completion of additional reports until the unit is officially re-certified..

With GMPc, the Unit's GSP reassessment documents will ensure

  •  Following authorities’ required forms and procedures
  • Saving time
  • Knowing the focal points that authorities require
  • Supporting certification audit through clear and concise articles

"GMPc Vietnam takes pride in being the first consultant that supports Esteem Investors their initial ventures to getting GSP certification"

GMPc Vietnam

Related services

Overall consultation on Designing and Constructing

Overall consultation on Designing and Constructing

GSP Training and Guidance

GSP Training and Guidance

Detail Construction and MEP Drawing

Detail Construction and MEP Drawing

Project Feasibility Study

Project Feasibility Study

Typical partner

  • 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
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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