GMPc Vietnam JSC
  • About Us  
    • Summary information
    • Key Personnel
  • Services  
    • 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
    • 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
    • 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
    • Eligibility For Cosmetic Manufacturing  
      • Overall consultation
      • Detail Construction and MEP drawing
      • Designing, Constructing, Ensured Certification
      • Preparation of Registration Dossier
    • GSP warehouses  
      • Project feasibility study
      • Detail Construction and MEP drawing
      • GSP Training and Guidance
      • Overall Consultation on Designing And Constructing
      • GSP Re-evaluation consultation
    • Pharmaceutical distribution center  
      • Feasibility Study
      • Design and Information Technology Solutions
      • Project Management and Supervision
      • GSP registration and operation consultancy
    • Dairy Factory  
      • Overall Planning
      • Detailed Construction & MEP Design - Project Budgeting
      • Contractor/Supplier Consultation and Project Management
      • Training, Drafting registration dossier
    • 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
  • Project
  • Video
  • GMP-Handbook
  • Faqs
  • News
  • Jobs
  • Contact

    SERVICES

  1. Home
  2. SERVICES
  3. CGMP ASEAN, ISO 22716

List of services

  • Pharmaceutical Facilities
  • 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
  • Register and Announce

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

CGMP ASEAN Re-evaluation Consultation

23/06/2021 | 450

"Directly inspecting the cosmetic manufacturing facility to analyze the gaps of existing system and make a plan to overcome the shortcomings combined with GMP training and finalizing registration dossier for CGMP ASEAN, ISO 22716 assessment as authorities' requirements"

Cosmetic manufacturing facilities in compliance with CGMP ASEAN,  ISO  22716 regulations are granted a  CGMP ASEAN,  ISO  22716 Certificate. According to regulations, the CGMP ASEAN, ISO 22716 certificate is valid for 3 years (or 5 years for veterinary medicine) the date of issue, so the facility needs to submit an application for CGMP re-evaluation before the certificate is expired, accordingly the Authority can set up a inspection team for assessment and renewed CGMP certification for the facility.

The CGMP re-evaluation Consultation Service designed by GMPc Vietnam consists of 6 steps as follows:

+ Step 1: Overall review

Review the entire facility and also internal inspection to analyze the gaps of existing system.

+ Step 2: Planning for Problems Solving

List the tasks and documents that need to be prepared for the GMP re-evaluation.

+ Step 3: GMP training

Combination of theoretical lectures and practical GMP on-job training with the update of latest regulations about related laws.

+ Step 4:  Supplement and finalizing registration dossier for the GMP revaluation

All record documents for 3 years at the facility include:

  • Remedy report of the previous assessment
  • Personnel and training records
  • Production activities records
  • Quality control activities records
  • Preservation activities records
  • Quality management system
  • Self-inspection
  • Legal records

+ Step 5: Submit the registration dossier to Adminstrative Department

Application for CGMP re-evaluation is the last step of the preparation process which proved to the authorities that after 3 years of obtaining CGMP certificate, the facilities remained to meet WHO GMP regulations, and more important, the authorities will base on it to set up an inspection team for facility re-evaluation.

+ Step 6: Defend against the inspection team

GMPc accompanies the facility in welcoming the GMP inspection team and continues to support the finalizing of additional reports until the facility is officially re-certified.

With GMPc services, your GMP revaluation dossier will be ensured in:

  • Gain the sympathy the authorities when receiving and evaluating
  • Saving time because the dossiers are responsive the star
  • Equip the necessary knowledge for the workforce to take control the presentation to GMP inspection team.
  • Confident presenting with definite report.

"GMPc Vietnam is the first Consultant committed to accompany customers until the date of receiving CGMP certification"

Related services

Preparation of CGMP/ ISO 22716 registration dossier

Preparation of CGMP/ ISO 22716 registration dossier

CGMP ASEAN Training and Guidance

CGMP ASEAN Training and Guidance

Project Management and Supervision

Project Management and Supervision

Detail Construction and MEP Drawing

Detail Construction and MEP Drawing

Technology and Equipment consultation

Technology and Equipment consultation

Project Feasibility Study

Project Feasibility Study

Typical partner

  • GMPc Vietnam JSC
  • Head Office: Blue Office, 4- BT1, Bui Xuan Phai Street, My Dinh 2 Ward, Nam Tu Liem 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 - Fax: 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
    • 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
    • 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
    • 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
    • Eligibility For Cosmetic Manufacturing
      • Overall consultation
      • Detail Construction and MEP drawing
      • Designing, Constructing, Ensured Certification
      • Preparation of Registration Dossier
    • GSP warehouses
      • Project feasibility study
      • Detail Construction and MEP drawing
      • GSP Training and Guidance
      • Overall Consultation on Designing And Constructing
      • GSP Re-evaluation consultation
    • Pharmaceutical distribution center
      • Feasibility Study
      • Design and Information Technology Solutions
      • Project Management and Supervision
      • GSP registration and operation consultancy
    • Dairy Factory
      • Overall Planning
      • Detailed Construction & MEP Design - Project Budgeting
      • Contractor/Supplier Consultation and Project Management
      • Training, Drafting registration dossier
    • 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
  • Project
  • Video
  • GMP-Handbook
  • Faqs
  • News
  • Jobs
  • Contact
 
Hotline: 0982.866.668
Nhắn tin Facebook Zalo: 0982.866.668