GLP Certification in Thailand:

GLP Certification in Thailand, Vertex Certifiers provides end-to-end GLP (Good Laboratory Practice) certification and compliance services in Thailand, supporting laboratories, CROs, research institutes, and testing facilities in achieving OECD GLP–aligned, Thai FDA–ready compliance. From GLP gap assessment, documentation, QA unit setup, and staff training to mock inspections and audit support, Vertex delivers practical, inspection-ready GLP solutions that ensure data integrity and international acceptance. We serve clients across Bangkok, Chonburi, Rayong, Pathum Thani, Samut Prakan, Ayutthaya, Chiang Mai, and Phuket, offering both onsite and remote GLP consulting tailored to Thailand’s regulatory environment and global sponsor expectations.

Who Needs GLP in Thailand?

Pharmaceutical and vaccine testing labs require GLP for Thai FDA submissions. Contract Research Organizations (CROs) in Bangkok and Chonburi handle multinational toxicology studies

Toxicology and safety assessment facilities in biotech parks
Medical device testers in Rayong’s industrial zones
Agrochemical and pesticide labs in Pathum Thani
Government institutes like NSTDA and Chulalongkorn University centers
Academic research in Chiang Mai and Khon Kaen hubs

How to get GLP Certification in Thailand

Step-by-Step GLP Implementation

1. GLP Gap Assessment

A structured audit against OECD GLP principles to review SOPs, data management systems, equipment calibration, and QA independence. Compliance gaps and risks are identified within 1–2 weeks.

2. Documentation Development

Development of a complete GLP Quality Manual, study plans, raw data templates, and SOPs for deviations and CAPA, fully aligned with Thai FDA expectations.

3. QA Unit Setup

Establishment of an independent Quality Assurance (QA) unit with defined audit authority and direct reporting to top management.

4. Training and Rollout

Role-specific GLP training for management, scientists, technicians, and QA teams. GLP systems are implemented across live studies, including computerized system validation.

5. Internal Audits

Execution of process, study-based, and facility audits, along with mock inspections simulating Thai FDA and sponsor audits.

6. Inspection Readiness

Closure of non-conformities, CAPA implementation, and preparation for sponsor or regulator inspections with continuous compliance monitoring.

GLP Timeline and Costs in Thailand

GLP implementation timelines align with common industry and NSTDA-linked expectations. Costs scale based on laboratory size, number of studies, and existing system maturity. A free GLP gap assessment is recommended for accurate pricing.

Lab Size	Timeline	Key Factors
Small Labs	1–3 months	Basic SOPs and study controls
Medium CROs	2–4 months	QA training and audits
Large Facilities	3–6 months	Full system and validation scope

Benefits of GLP Compliance

GLP compliance enables Thai FDA submission readiness and ensures OECD Mutual Acceptance of Data (MAD), eliminating duplicate testing and reducing costs. Thai laboratories report 25%+ higher contract win rates, reduced inspection risk, and fully traceable study data supporting biotech exports.

GLP strengthens Thailand’s bioeconomy, supporting TBES-aligned enterprises and improving governance across pharmaceutical and life sciences markets valued at USD 2 billion+.

Benefit	Impact in Thailand
FDA Approval	Direct Thai FDA submissions
Global Validity	No duplicate testing under OECD MAD
Contract Wins	Higher CRO and sponsor success
Risk Reduction	Improved audit outcomes

GLP vs ISO 17025 – Comparison

Aspect	GLP	ISO 17025
Focus	Study integrity	Testing competence
Scope	Non-clinical safety studies	All calibration and testing
Proof of Compliance	Regulatory inspections	Accreditation certificate
Thai Application	Thai FDA / OECD	General laboratory use
Combined Use	Common for CROs	Shared QA systems

Many laboratories in Thailand implement GLP and ISO 17025 together for comprehensive regulatory and technical credibility.

Vertex Certifiers: Your GLP Partner in Thailand

Vertex Certifiers delivers OECD-aligned GLP implementation covering gap analysis, documentation, training, mock audits, and inspection preparation. Our onsite and remote services support laboratories across Bangkok, Chiang Mai, Pattaya, Rayong, Chonburi, and Khon Kaen, with fast-track solutions for SMEs and CROs backed by proven Southeast Asia experience.

Request a Free GLP Gap Assessment

Achieve GLP compliance confidently with expert guidance.

✔ Free initial assessment
✔ Tailored roadmap & transparent costs
✔ Inspection-ready in months

📧 info@vertexcertifiers.com
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