About This Case Study
This case study highlights how DHG Pharmaceutical Joint Stock Company (DHG Pharma) achieved EU GMP certification with Computer System Validation (CSV) consulting support from Factorytalk, establishing a structured, risk-based approach to validation across its GxP systems.
As one of Vietnam’s leading pharmaceutical manufacturers, DHG Pharma develops and produces prescription medicines, over-the-counter (OTC) products, dietary supplements, and healthcare products for domestic and global markets.
Working closely with DHG Pharma’s Quality, IT, Engineering, and Manufacturing teams, Factorytalk helped establish a GAMP 5 risk-based validation approach, complete validation activities within a demanding certification timeline, and strengthen the internal capability needed to maintain validated systems throughout their lifecycle.
What this case study reviews
The case study explores how DHG Pharma addressed the validation challenges associated with preparing a large and diverse GxP system landscape for EU GMP certification.
It covers:
- The CSV challenges DHG Pharma faced on its EU GMP journey
- Why a GAMP 5 risk-based validation strategy was adopted
- How Factorytalk supported risk assessment, validation planning and execution
- How cross-functional collaboration supported compliance throughout the project
- How practical knowledge transfer strengthened DHG Pharma’s internal CSV capability
DHG Pharma Q&A
CSV was one of the GMP-related areas DHG Pharma needed to address as part of its EU GMP certification programme.
The challenge was not only technical; validation activities also had to be completed within a limited timeframe across a large and diverse system landscape.
Factorytalk worked with DHG Pharma to establish a structured validation programme aligned with GAMP 5 and regulatory expectations.
A GAMP 5 risk-based approach was adopted.
Rather than applying the same level of validation effort to every system, DHG Pharma focused resources according to each system’s potential impact on product quality, patient safety, and data integrity.
This helped establish a more practical and sustainable approach to validation across multiple GxP systems.
Factorytalk supported DHG Pharma from validation planning through execution.
The work included conducting risk assessments and defining validation scope, developing validation plans aligned with GAMP 5, collaborating with Quality, IT, Engineering, and Manufacturing teams, and providing practical mentoring and knowledge transfer.
A key objective was not simply to complete the immediate validation activities, but to help DHG Pharma develop the internal capability to maintain its systems in a validated state after project completion.
The programme supported DHG Pharma in successfully passing its EU GMP certification audit. Computer System Validation (CSV) documentation and activities were reviewed and accepted during the inspection.
Beyond the certification milestone, DHG Pharma established a sustainable risk-based validation process for future system lifecycle management and strengthened its organisational capability to manage CSV internally. Top of Form
