GMP-WHO Certification for Pharmaceutical Manufacturing Facilities

GMP-WHO Consulting, Training & Certification Support

✓ Support businesses in meeting GMP-WHO requirements in accordance with the regulations of the Ministry of Health.

✓ Assist in preparing documentation and ensuring readiness for GMP-WHO inspections conducted by the Drug Administration of Vietnam (DAV), Ministry of Health.

✓ Experienced consultants provide on-site consulting, training, and implementation support throughout the project.

✓ Support the development of GMP-WHO documentation, including SOPs, Validation documents, QA/QC documentation, and inspection-ready records.

✓ Deliver GMP-WHO training for management teams, QA, QC, production personnel, and other relevant departments.

✓ Strengthen the quality management system, enhance manufacturing capabilities, and support compliance with GMP-WHO requirements.

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Chứng nhận GMP WHO cho nhà máy dược phẩm

GMP-WHO Consulting, Training & Certification Support

✓ Support businesses in meeting GMP-WHO requirements in accordance with the regulations of the Ministry of Health.

✓ Assist in preparing documentation and ensuring readiness for GMP-WHO inspections conducted by the Drug Administration of Vietnam (DAV), Ministry of Health.

✓ Experienced consultants provide on-site consulting, training, and implementation support throughout the project.

✓ Support the development of GMP-WHO documentation, including SOPs, Validation documents, QA/QC documentation, and inspection-ready records.

✓ Deliver GMP-WHO training for management teams, QA, QC, production personnel, and other relevant departments.

✓ Strengthen the quality management system, enhance manufacturing capabilities, and support compliance with GMP-WHO requirements.

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GMP-WHO certification for pharmaceutical manufacturing

According to the regulations of the Ministry of Health, pharmaceutical manufacturing facilities must comply with Good Manufacturing Practice (GMP-WHO) requirements before commencing operations. GMP-WHO certification is also an important benchmark for evaluating the capability of pharmaceutical manufacturers and is often required for product registration, tender participation, contract manufacturing, and pharmaceutical exports.

As a result, many companies engage professional GMP-WHO consulting and certification providers to ensure a structured implementation approach and optimize project timelines.

**For companies seeking to expand into international markets, GMP-WHO certification is often the first step toward meeting more stringent pharmaceutical standards such as EU-GMP, PIC/S-GMP, Japan GMP, and FDA GMP.

What does a pharmaceutical manufacturer need to achieve GMP-WHO certification?

Achieving GMP-WHO certification requires a comprehensive approach to pharmaceutical manufacturing in accordance with Good Manufacturing Practice (GMP) principles. Depending on the current status of the facility, companies should develop an appropriate implementation roadmap to optimize resources, reduce compliance risks, and improve readiness for GMP-WHO certification.

The following are four key areas that pharmaceutical manufacturers should focus on when implementing GMP-WHO.

Cơ sở hạ tầng chuẩn GMP WHO trong phòng sạch dược phẩm

Infrastructure

Facility design based on unidirectional process flow principles
Cleanroom areas suitable for the intended dosage forms
HVAC systems for environmental control
Storage areas that meet requirements for raw materials and finished products

Hệ thống quản lý chất lượng đạt chuẩn chứng nhận GMP WHO

Quality Management System

SOPs covering manufacturing and quality control activities
QA and QC procedures for deviation management
GMP documentation and production records with full traceability
Change control, CAPA, and quality risk management processes

Personnel

Qualified responsible personnel in accordance with regulatory requirements
Competent QA, QC, and production teams
Regular GMP-WHO training programs for relevant staff
Ongoing competency assessment and quality awareness programs

Validation & Qualification

Qualification of facilities, equipment, and supporting systems
Validation of manufacturing and cleaning processes
Qualification of purified water and pharmaceutical water systems
Performance verification of HVAC systems and cleanroom environments

What does a pharmaceutical manufacturer need to achieve GMP-WHO certification?

Achieving GMP-WHO certification requires a comprehensive approach to pharmaceutical manufacturing in accordance with Good Manufacturing Practice (GMP) principles. Depending on the current status of the facility, companies should develop an appropriate implementation roadmap to optimize resources, reduce compliance risks, and improve readiness for GMP-WHO certification.

The following are four key areas that pharmaceutical manufacturers should focus on when implementing GMP-WHO.

Infrastructure

Facility design based on unidirectional process flow principles
Cleanroom areas suitable for the intended dosage forms
HVAC systems for environmental control
Storage areas that meet requirements for raw materials and finished products

Quality Management System

SOPs covering manufacturing and quality control activities
QA and QC procedures for deviation management
GMP documentation and production records with full traceability
Change control, CAPA, and quality risk management processes

Personnel

Qualified responsible personnel in accordance with regulatory requirements
Competent QA, QC, and production teams
Regular GMP-WHO training programs for relevant staff
Ongoing competency assessment and quality awareness programs

Validation & Qualification

Qualification of facilities, equipment, and supporting systems
Validation of manufacturing and cleaning processes
Qualification of purified water and pharmaceutical water systems
Performance verification of HVAC systems and cleanroom environments

Documents required for GMP-WHO certification

To assess the current status of the facility and develop an appropriate GMP-WHO implementation roadmap, companies should prepare a set of basic documents related to legal compliance, manufacturing operations, and available resources.

These typically include:

Business Registration Certificate
Legal documents related to pharmaceutical manufacturing activities
Information on manufacturing facilities, production lines, and equipment
List of products or dosage forms intended for manufacture
Facility layout and organizational structure chart
Key personnel records (Responsible Person, QA, QC, etc.)
Existing GMP-WHO documentation and records (if available)

Most specialized documents, including the Quality Manual, SOPs, Validation and Qualification records, QA/QC documentation, and materials required for GMP-WHO certification assessment, can be developed and completed with guidance from SQS Global experts throughout the implementation process.

Common reasons for GMP-WHO assessment failure

Investing in facilities, equipment, or GMP-WHO documentation alone does not necessarily mean a company is ready for GMP-WHO assessment. In practice, many pharmaceutical manufacturers face delays or require significant corrective actions because GMP-WHO implementation was not planned properly from the outset.

Common reasons include:

Starting GMP-WHO implementation only after facility construction has been completed
Lack of a proper gap assessment and compliance analysis
Investing in infrastructure without aligning it with the quality management system
Failure to prioritize critical GMP-WHO implementation activities
Limited experience in preparing for GMP-WHO inspections and assessments
Additional costs caused by facility modifications and corrective actions after construction
Lack of expert support throughout implementation and internal audit activities

For this reason, many pharmaceutical manufacturers engage GMP-WHO consulting services at an early stage to minimize compliance risks and improve their chances of achieving GMP-WHO certification successfully.

GMP-WHO Implementation Timeline

The time required to achieve GMP-WHO certification varies depending on the facility’s current conditions, the maturity of its quality management system, and the resources available for implementation.

New Facility

12–24 Months

Completed Facility

6–12 Months

Documentation Only

3–6 Months

Every pharmaceutical manufacturing facility has different operational conditions, business objectives, and levels of GMP-WHO compliance. SQS Global helps businesses develop a tailored implementation roadmap, provide consulting and training, establish the required documentation system, and prepare for GMP-WHO inspections conducted by the Drug Administration of Vietnam (DAV), Ministry of Health. Throughout the project, businesses work with a single point of contact for seamless implementation.

Common reasons for GMP-WHO assessment failure

Investing in facilities, equipment, or GMP-WHO documentation alone does not necessarily mean a company is ready for GMP-WHO assessment. In practice, many pharmaceutical manufacturers face delays or require significant corrective actions because GMP-WHO implementation was not planned properly from the outset.

Common reasons include:

Starting GMP-WHO implementation only after facility construction has been completed
Lack of a proper gap assessment and compliance analysis
Investing in infrastructure without aligning it with the quality management system
Failure to prioritize critical GMP-WHO implementation activities
Limited experience in preparing for GMP-WHO inspections and assessments
Additional costs caused by facility modifications and corrective actions after construction
Lack of expert support throughout implementation and internal audit activities

For this reason, many pharmaceutical manufacturers engage GMP-WHO consulting services at an early stage to minimize compliance risks and improve their chances of achieving GMP-WHO certification successfully.

GMP-WHO Implementation Timeline

The time required to achieve GMP-WHO certification varies depending on the facility’s current conditions, the maturity of its quality management system, and the resources available for implementation.

New Facility

12–24 Months

Completed Facility

6–12 Months

Documentation Only

3–6 Months

Every pharmaceutical manufacturing facility has different operational conditions, business objectives, and levels of GMP-WHO compliance. SQS Global helps businesses develop a tailored implementation roadmap, provide consulting and training, establish the required documentation system, and prepare for GMP-WHO inspections conducted by the Drug Administration of Vietnam (DAV), Ministry of Health. Throughout the project, businesses work with a single point of contact for seamless implementation.

GMP-WHO Consulting, Implementation & Certification Support Process

SQS Global provides comprehensive GMP-WHO consulting, training, implementation, and certification support services for pharmaceutical manufacturers. Based on each facility’s current conditions, our experts develop a tailored implementation roadmap to optimize project timelines, improve operational readiness, and help businesses prepare for GMP-WHO inspections conducted by the Drug Administration of Vietnam (DAV), Ministry of Health.

1 | Initial Assessment & GMP-WHO Roadmap

Review facility, product, and dosage form information
Assess infrastructure, quality systems, and compliance status
Develop a tailored GMP-WHO implementation roadmap

2 | Gap Assessment & Facility Survey

Evaluate facilities, equipment, HVAC, and water systems
Identify compliance gaps against GMP-WHO requirements
Define corrective actions and implementation priorities

3 | GMP-WHO Training & Team Development

Train management, QA, QC, and production personnel
Support practical GMP-WHO implementation activities
Strengthen quality culture and compliance awareness

4 | GMP-WHO Documentation Development

Develop Quality Manuals, SOPs, and GMP documentation
Establish QA/QC, CAPA, and change control systems
Prepare records required for GMP-WHO assessment

5 | Validation, Qualification & Internal Audit

Perform Validation and Qualification activities
Conduct internal audits and readiness reviews
Address nonconformities and complete documentation

6 | GMP-WHO Inspection Support

Prepare GMP-WHO inspection application documents
Support preparation for GMP-WHO inspections
Provide inspection support and assist with corrective actions, if required

Note: GMP-WHO certificates are valid for three years and are subject to periodic inspections by the Drug Administration of Vietnam (DAV), Ministry of Health. SQS Global helps businesses maintain compliance, keep documentation up to date, and prepare for surveillance inspections throughout the certification cycle.

Why Choose a Trusted GMP-WHO Certification Support Partner Like SQS Global?

Unlike many management system standards, GMP-WHO requires full alignment between facilities, personnel, GMP documentation, and manufacturing operations. With extensive experience in GMP-WHO consulting, training, and implementation support for pharmaceutical manufacturers, SQS Global delivers end-to-end solutions that help businesses shorten implementation timelines, optimize resources, and improve readiness for GMP-WHO inspections conducted by the Drug Administration of Vietnam (DAV), Ministry of Health.

End-to-End Consulting & Implementation

SQS Global supports businesses from initial assessment and training to documentation development and GMP-WHO inspection readiness.

Experienced GMP-WHO Specialists

Our experts have practical experience in GMP-WHO implementation, covering pharmaceutical facilities, quality systems, validation, and regulatory requirements.

Practical Implementation Approach

Implementation roadmaps are tailored to each facility’s size, business sector, and development objectives, ensuring effective adoption and sustainable operation.