MAIN REASONS

REAL STATE OF BUIDING PHARMACEUTICAL FACTORY ACCORDING TO EU GMP STANDARD 
3. Total investment is much higher than expected
2. The project implementation time was delayed longer than expected
1. Poor quality feasibility study report 
2. Inadequate evaluation to choose qualified consultant
1. Without achieving success/ target, many project was clock-stop
3. Not prepared enough high-quality personnel to work with the Consultant 
OPTIMAL SOLUTION FOR INVESTORS
Make a feasibility study report basing on the model of Local consultant (chair) incorporating foreign consultant.
Comprehensive evaluation of consultant unit 
Selection of model of foreign consultant (chair) - combined with local consultant.
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  • Synthesize and systematize all needs and requirements of the project.
  • Concept layout and main explanation of technology-engineering.
  • Make a preliminary estimation of investment costs.
  • Investment analysis and make the implementation master plan of project.
  • Analyze and evaluate the effectiveness and feasibility of the project.

G02.
Design & Construction supervision

  • Basic design
  • Detailed design
  • Construction
  • Construction management

G03.
QM documentation – Validation

  • Training: Building training modules according to EU GMP principles including EU GMP general principles,Quality management system, qualification/Validation activities.
  • QM SOP: Supporting the development of documents and operating instructions for the pharmaceutical quality system according to EU GMP.
  • Validation/qualification: Support to build VMP, URS, develop qualification documents of equipments/systems/facility, support qualification/validation activities.

G04.
GMP application and product dossier application

  • Support, follow up until EU GMP certificate is issued.
  • Manage and monitor the process of submitting product applications for MA.

G01.
Feasibility study report

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TURN-KEY EU GMP PROJECT CONSULTING SERVICE
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ABOUT US

The leading consulting firm on GMP in Vietnam

More than 270 GMP projects have been implemented, accounting for 80% of newly built factories

High standard GMP projects consulted

Detail

Inotek Pharma Solutions is headquartered in India. As a global provider of design and construction solutions for Biotechnology, Pharmaceutical, API, Medical Device manufacturing facilities. Each of the key members at Inotek has over 20 years of experience in the Pharmaceutical industry with expertise in areas such as Equipment Manufacturing, Quality Compliance, Engineering & Project Management.
Applying the "First Time Right" and "Attention to Details" approach has always been Inotek's main focus in executing projects on schedule and with high efficiency.
Inotek Pharma is honored to be in the Top 10 Turnkey Pharmaceutical Project Contractors & Consultants in 2022 published on India Pharma Outlook.

STRATEGIC PARTNERSHIP

www.inotek.co.in

On March 3, 2023. GMPc Vietnam signed a strategic cooperation contract with Inotek.
Providing comprehensive consultancy service for high standard pharmacetical factory in Viet Nam.
Established since May 25, 2011 GMPc proud to have been the pioneer consultant in providing a comprehensive and turnkey consulting model for GMP-certified facility projects.
Having competent manager, GMP experts and professional team of staff including pharmacists, engineers, chemists,..with several years experiences on GMP practices at large-scales factories, we have always been dedicating ourselves into each commissioned project while adhering to the core value of Get GMP – Get what you want!
GMPc has been trusted by most nationwide investors with 270 GMP-certified facility projects, which equals to more than 80% market share in Vietnam from 2011 to 2023. Because of customer's faith, we ensure to be always do our best to create and contribute the consulting solutions that Simplification - Cost Optimization - Guaranteed Certification on the basis of understanding the needs and differentiation strategy of each customer.

PROFESSIONAL CONSULTANT

Mr. Sunil Lande

Founder & CEO of Inotek

Mr. Rohit Ochaney

Co-Founder & Policymaker Inotek

Mr. Nirmal Ankaney

Inotek's Sales Manager

Mr. Dao Xuan Huong

Founder & Chairman of GMPc Vietnam

Mr. Trinh Minh Thang

GMP Senior Consultant

Mr. Nguyen The Giang

Project Director GMPc Vietnam

Mrs. Le Thi An

GMP Consultant

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TYPICAL PROJECTS IMPLEMENTED

Mediplantex pharmaceutical factory (EU GMP)

Address: Hoa Lac Hi-Tech Park, Hanoi

Nippon Chemiphar Pharmaceutical Factory (Japan GMP) 

Address: 76 Doc Lap Avenue, Di An, Binh Duong

Dinlas Pharma factory (Bliss GVS) (EU GMP)

Address: Syokimau, Nairobi, Kenya 

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Factory Zuma Pharmaceutical Ltd (EU GMP)

Address: Karakalpak 111306, Uzbekistan

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QUESTIONS & ANSWERS

1. Why do people often choose Eastern European countries to apply for GMP as Western European countries?

2. Validity GMP certificate 

4. During the 3 years of validity of a GMP certificate, is it necessary to export at least one batch of product to the European market for GMP re-inspection?

3. Who has the authority to issue EU GMP certification?

- GMP certificate is valid for three years from the most recent date of inspection, but the period of validity can be shortened under special circumstances.
- Since a GMP certificate refer to a specific inspection, it can not be renewed or reissued until a new inspection is conducted and completed with adequate follow-up.
- Although the same EU GMP standard. however it seems that inspectors in Eastern European countries are "easy going" than inspectors in Western European countries.
- Eastern European countries are often selected to apply for GMP such as Hungary, Croatia, Malta, Romania.
- When applying for EU GMP and scheduling inspection, the authorities of these countries are not required to submit simultaneously the MA dossier application.
The Drug Administration of the EU countries includes 28 countries: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, The Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden.
Within 3 years of validity of the EU GMP certificate, the manufacturer must produce and export at least 1 batch of products to the EU market to have the right to be re-validated.

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CONTACT US IMMEDIATELY TO GET CONSULTATION

Copyright © 2023 GMPc. All rights reserved.

INOTEK JOINT STOCK COMPANY

Address: 1811, Solus, Hiranandani Estate, Thane, India

Tel: +91 865505 1600

Email: info@inotek.co.in

GMPC VIETNAM JOINT STOCK COMPANY

Head office: No. 18, Mang Cam 1 Street, An Lac Green Symphony Urban Area, Van Canh, Hoai Duc, Hanoi City

Tel: 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

Branch office (Hanoi): No. 32, Vi Cam 5 Street, An Lac Green Symphony Urban Area, Van Canh, Hoai Duc

Mr. Nguyen The Giang has joined GMPc Vietnam since very first days of establishment (2013) in charge of M&E engineer. With the outstanding ability and enthusiasm, Mr Giang has proven his worth and outstanding maturity via hundreds of large-scale constructional GMP facility projects. From a M&E engineer, Mr. Giang has been appointed as Project Director of GMPc since 2018.

Before joining GMPc Vietnam, Mr. Giang was an Engineer of DAESHIN Korea Company (2010 - 2013).

Mr. Giang had an Engineering Degree in Electrical Engineering Technology (graduated in 2010), Hanoi University of Industry.

Mr. Nguyen The Giang

Project Director GMPc Vietnam

Pharmacist Trinh Minh Thang has joined GMPc Vietnam since 2013 as a GMP Consultant and has been in charge of Regulations at GMPc Representative Office in HCM since 2019.

Before joining GMPc Vietnam, Mr. Thang had 04 years of experience working in pharmaceutical manufacturer that in compliance with GMP WHO/PICS guideline (Roussel VN Company: 2009-2011, United International Pharma Co., Ltd.: 2011-2013) as Staff/Specialist of QA.

Mr. Thang had a degree of Pharmacist from the University of Medicine and Pharmacy at Ho Chi Minh City in 2009.

Mr. Trinh Minh Thang

GMP Senior Consultant

Mr. Dao Xuan Huong is the Founder and Board Chairman of GMPc Vietnam. As a visionary decisive leader with keen intelligence and sincerity above all, he is responsible for vision orientation, strategic management and supporting the Executive Board with the goal of maintaining the leading position in the field of turnkey consulting solution for GMP facility in Vietnam and reaching out the reputation to ASEAN market.
Before founding GMPc Vietnam, Mr. Huong was occupied many senior management positions at multinational companies and corporations such as:
• General Director of LiLi of France Joint Stock Company (2008 - 2011)
• General Director of VIT High tech Global Corp (2004 - 2007)
• Project manager of VKX - Joint Venture Company between LGE and VNPT (2000 - 2004)

Mr. Dao Xuan Huong

Founder & Chairman of GMPc Vietnam

  • Prepare a set of documents to submit to the agency.
  • Appointment of legal representative in the EU country of interest.
  • Submit the documents to agency.
  • Perform Pre-Audit
  • Coordinate inspection schedule, support inspection process.
  • Support, follow up until EU GMP certificate is issued.
  • Provide registration services by national procedure or decentralized procedure.
  • Implement trial production activities.
  • Guidance on process validation, cleaning validation, annalitical method validation.
  • Guidance on stability study and bioequivalence.
  • Building the eCTD dossier.
  • Manage and monitor the process of submitting product applications for MA.
  • Product dossier application
  • EU GMP application 

Updating

Mr. Sunil Lande

Founder & CEO of Inotek

Updating

Mr. Rohit Ochaney

Co-Founder & Policymaker Inotek

Updating

Mr. Nirmal Ankaney

Inotek's Sales Manager

Updating

Mrs. Le Thi An

GMP Consultant