GMP of Ministry of Health of Vietnam, GMP WHO Consulting - Training, Consulting and GMP Assessment Services in accordance with WHO GMP and the Ministry of Health of Vietnam

GMP training courses, GMP WHO and GMP design

Introduction to WHO GMP and Vietnam MOH GMP

GMP (Good Manufacturing Practices) is a system of principles, requirements, and guidelines intended to ensure that pharmaceutical products, active pharmaceutical ingredients (APIs), and healthcare products are consistently manufactured and controlled according to quality standards appropriate for their intended use, marketing authorization dossier, and patient safety requirements.

According to the latest guidelines of World Health Organization (WHO GMP TRS 986 and current GMP Annexes) and the regulations of the Ministry of Health of Vietnam under Circular No. 28/2025/TT-BYT, pharmaceutical manufacturers and API manufacturers are required to establish and maintain a Pharmaceutical Quality System (PQS) based on the principles of Quality Risk Management (QRM), ensuring:

Product quality;
Product safety;
Product efficacy;
Cross-contamination control;
Traceability;
Data Integrity;
Continuous improvement of the GMP system.

For medicinal products already granted marketing authorization, the products must be manufactured by licensed manufacturers and periodically inspected and evaluated by competent regulatory authorities in accordance with applicable GMP principles.

WHO GMP currently serves as the foundation for:

WHO GMP;
PIC/S GMP;
EU GMP;
ASEAN GMP;
and many other international GMP systems for pharmaceuticals, vaccines, biological products, APIs, and pharmaceutical packaging materials.

Scope of GMP Application

GMP applies to:

Finished pharmaceutical products;
Active Pharmaceutical Ingredients (APIs);
Sterile pharmaceutical products;
Vaccines and biological products;
Herbal medicines and traditional medicines;
Health supplements and nutraceuticals;
Primary pharmaceutical packaging materials;
Industrial-scale pharmaceutical manufacturing;
Manufacturing for clinical trial products;
Supporting systems such as HVAC, PW/WFI water systems, clean compressed air, cleanrooms, and pharmaceutical laboratories.

GMP Training and Consulting Services by VINTECOM International

VINTECOM International provides GMP training, consulting, and implementation support services based on the latest international standards and guidelines, including:

WHO GMP consulting services;
Sterile pharmaceutical, vaccine, and biological GMP consulting;
PIC/S GMP consulting;
EU GMP consulting;
API GMP consulting (ICH Q7);
Herbal medicine and traditional medicine GMP consulting;
Health supplement GMP consulting;
Pharmaceutical cleanroom and HVAC GMP consulting;
Validation & Qualification consulting;
Data Integrity and electronic GMP documentation system consulting;
Pharmaceutical packaging GMP and ISO 15378 consulting;
GMP internal auditor training and GMP Mock Audit services.

GMP System Implementation Contents

1. Pharmaceutical Quality System (PQS) Development

The PQS system in accordance with WHO GMP and Vietnam MOH GMP includes:

Independent QA/QC system;
SOP and GMP documentation system;
Change Control;
Deviation management;
CAPA;
Risk Assessment;
Product Quality Review (PQR/APQR);
Supplier Qualification;
Self Inspection;
Complaint & Recall management;
Data Integrity ALCOA+;
Validation Master Plan (VMP).

2. GMP Documentation System Development

The GMP documentation system includes:

SOP (Standard Operating Procedures);
Master Batch Records;
Batch Manufacturing Records;
Protocols and Reports;
Specifications;
Validation Documents;
Logbooks;
Technical Agreements;
Traceability records;
Change Control records;
Deviation investigation and CAPA records.

GMP documentation must be:

version controlled;
approved;
easily retrievable;
compliant with Data Integrity principles;
compliant with GDP (Good Documentation Practice).

3. Validation & Qualification Consulting

VINTECOM supports the implementation of:

DQ (Design Qualification);
IQ (Installation Qualification);
OQ (Operational Qualification);
PQ (Performance Qualification);
Process Validation;
Cleaning Validation;
HVAC Qualification;
Water System Validation;
Computerized System Validation (CSV);
Analytical Method Validation.

4. GMP Facility and Cleanroom Consulting

Including:

GMP facility layout design;
Material and personnel flow design;
Cleanroom classification;
Pressure cascade design;
HVAC systems;
Air change rate calculations;
HEPA filtration systems;
Environmental Monitoring systems;
Smoke Studies;
Contamination Control Strategy (CCS).

Benefits of Implementing WHO GMP and Vietnam MOH GMP

Control and minimize risks of cross-contamination, mix-ups, and manufacturing errors;
Ensure product consistency and batch-to-batch uniformity;
Enhance QA/QC capability and traceability;
Improve regulatory compliance and inspection readiness;
Meet international tender, export, and OEM requirements;
Increase confidence from customers and regulatory authorities;
Support the transition from end-product testing to risk-based quality management;
Optimize investments in facilities, HVAC, and utility systems;
Strengthen competitiveness and corporate brand protection.

Capability of VINTECOM International Experts

The expert team of VINTECOM International has extensive experience in:

WHO GMP;
PIC/S GMP;
EU GMP;
ISO 15378;
ISO/IEC 17025;
Pharmaceutical QA/QC;
Validation & Qualification;
HVAC & Cleanroom systems;
Data Integrity;
Pharmaceutical Packaging systems.

The experts have participated in training, consulting, and assessment projects for many organizations, research institutes, hospitals, laboratories, pharmaceutical manufacturers, biological product companies, healthcare organizations, and cleanroom projects in Vietnam.

Registration for GMP Training and Consulting Services

Pharmaceutical manufacturers, API manufacturers, health supplement companies, medical device manufacturers, laboratories, hospitals, and healthcare organizations seeking training or consulting services for:

WHO GMP;
Vietnam MOH GMP;
PIC/S GMP;
EU GMP;
GLP;
GDP;
GSP;
ISO 15378;
HACCP;
ISO/IEC 17025;

📶📶📶 Contact us to register for GMP of Ministry of Health of Vietnam, GMP WHO Training Course, Consulting and certification Services.

Customers, organizations and enterprises require Training course, Consulting and Certification services of GMP of Ministry of Health of Vietnam, GMP WHO, please click on "Registration - Quotation" or on the right toolbar below the PC screen to receive a quotation for training, consulting and certification services.

📶📶📶 Further information, Please contact us as below:

☎ VINTECOM International Office in Ha Noi City: 16th Floor - Green Stars City, 234 Pham Van Dong Street, Phu Dien Ward, Hanoi City. Hotline 094-886-5288/ (024) 730-588-58

☎ VINTECOM International Office in Ho Chi Minh City: Glory Height Vinhome Grand Park - 88 Phuoc Thien Street, Long Binh Ward, HCM City. Hotline 0938-083-998/ (028) 7300-7588