GLP Certification in Taiwan:

GLP Certification in Taiwan, Vertex Certifiers provides end-to-end GLP certification and compliance services in Taiwan, helping pharmaceutical laboratories, CROs, biotech companies, and research institutes achieve OECD-aligned, TFDA-ready GLP compliance with full inspection confidence. Our services cover the complete implementation lifecycle, including gap assessment, custom documentation, QA unit setup, staff training, internal audits, and mock inspections, tailored to Taiwan’s regulatory environment. We serve organizations across major research and industrial hubs, including Taipei, Taichung, Kaohsiung, and Hsinchu, offering flexible onsite and remote consulting models. Vertex Certifiers focuses on practical, operational GLP systems that ensure sustainable compliance, global data acceptance, and long-term regulatory readiness.

Good Laboratory Practice (GLP) sets quality standards for non-clinical health and environmental safety studies in pharmaceuticals, biotech, and chemicals. Taiwan’s GLP program supports its growing Asia-Pacific role in CRO markets and drug development. GLP aligns with OECD principles, enabling Mutual Acceptance of Data (MAD) for international submissions. This reduces redundant testing and boosts Taiwan’s competitiveness against Japan and China

What Is GLP and Why It Matters

GLP ensures study planning, conduct, monitoring, recording, reporting, and archiving produce reliable data. Unlike GMP (manufacturing) or GCP (clinical trials), GLP targets non-clinical lab studies. In Taiwan, GLP drives TFDA approvals for drugs, devices, and exports, building sponsor confidence and securing contracts in competitive Asia-Pacific markets

Studies Covered Under GLP

GLP covers toxicology, safety pharmacology, pharmacokinetics, ADME, genotoxicity, carcinogenicity, medical device biocompatibility, agrochemical residues, and environmental fate studies. TFDA requires GLP for drugs, cosmetics, health foods, and pesticides. Product categories include pharmaceuticals, veterinary drugs, food additives, feed additives, industrial chemicals, and medical devices with biocompatibility testing

Procedure to get GLP Certification in Taiwan:

GLP Implementation Process in Taiwan

GLP implementation starts with a gap assessment against OECD/TFDA standards, followed by a risk evaluation of laboratory practices. Based on the findings, facilities develop a GLP Quality Manual, SOPs, and study templates and establish an independent QA unit with training.

Systems are rolled out across studies, internal audits and mock inspections are conducted, and corrective actions are implemented to achieve TFDA inspection readiness.

Inspections and Audits

TFDA and TAF conduct voluntary routine inspections, including facility and study audits, as well as application-based checks. Key focus areas include data integrity, QA independence, study conduct, and computerized systems. Compliant facilities, such as those with GLP0002 valid to 2027, are publicly listed by TAF.

Findings trigger Corrective and Preventive Actions (CAPA), and re-inspections are conducted to address deficiencies.

Certification Timeline

Small labs: 3–6 weeks
Medium CROs: 6–8 weeks
Large/multi-site facilities: 8+ weeks

Timelines depend on study volume, documentation quality, and digital system readiness. TAF registration follows successful inspection, with annual monitoring for ongoing compliance.

Cost Considerations

Costs vary based on lab size and complexity. Typical expenses include:

Certificate
Annual monitoring:
Implementation costs for small labs
Additional travel fees for multi-site audits

Engaging a GLP consultant helps optimize costs, improve efficiency, and ensure accurate budgeting through a preliminary gap assessment.

Regulatory Framework

Taiwan’s GLP regulations are governed by TFDA (Taiwan Food and Drug Administration) and overseen by the Ministry of Health and Welfare (MOHW). The Taiwan Accreditation Foundation (TAF) acts as the Compliance Monitoring Authority (CMA), managing inspections and facility registration per OECD guidance.

Taiwan participates in the OECD Mutual Acceptance of Data (MAD) via its national program (2006) and recognizes foreign GLP data from adherent countries. Since 2010, the US EPA also recognizes Taiwan GLP for pesticides and chemical studies.

GLP Principles in Taiwan

Management responsibility and oversight
Independent QA units conducting audits
Approved study protocols
Data integrity and raw data handling
Equipment qualification and maintenance
Computerized system validation
Long-term archiving
Validated electronic records with audit trails

SOPs ensure reproducibility and compliance with OECD/TFDA requirements.

Common Challenges for Taiwanese Labs

Copy-paste documentation not aligned with operations
Weak QA independence
Unvalidated LIMS and spreadsheets
Poor deviation and CAPA management
Archiving gaps and record-keeping issues
GLP conflicts with ISO 17025 systems
Maintaining digital data integrity

Regional competition emphasizes the need for robust GLP systems to maintain regulatory credibility and international acceptance.

Get GLP Certified in Taiwan – Free Consultation

Achieve inspection-ready GLP compliance with expert guidance from Vertex Certifiers.

✔ Free GLP gap assessment
✔ Customized implementation roadmap and cost clarity
✔ Internal audits and mock inspections

📧 info@vertexcertifiers.com
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