GLP Certification in Saudi Arabia:
GLP Certification in Saudi Arabia, Vertex Certifiers provides end-to-end GLP (Good Laboratory Practice) certification and compliance services in Saudi Arabia, helping laboratories, CROs, research centers, and testing facilities achieve OECD GLP–aligned, SFDA-ready compliance with full inspection confidence. From GLP gap assessment, documentation, QA unit setup, and staff training to mock inspections and audit support, Vertex delivers practical, regulator-accepted solutions—not just paperwork. We support clients across Riyadh, Jeddah, Dammam, Khobar, Dhahran, Jubail, Yanbu, Mecca, Medina, Taif, Tabuk, Abha, Qassim, Al-Ahsa, and NEOM, offering both onsite and remote GLP consulting tailored to Saudi regulatory expectations and international sponsor requirements.
Saudi Arabia’s laboratories in pharmaceuticals, biotech, and research require GLP certification to ensure data integrity and gain SFDA approval amid Vision 2030’s sector growth. This guide details GLP compliance steps, benefits, and implementation for KSA facilities seeking international recognition. Vertex Certifiers provides expert support for Riyadh, Jeddah, and Dammam labs to achieve audit-ready status.
Why GLP Certification Matters in Saudi Arabia
Saudi Arabia advances its biotech and pharmaceutical industries under Vision 2030, investing billions to boost local manufacturing from 20% to 40% of market needs by 2030. Laboratories generating non-clinical safety data for SFDA submissions must follow OECD GLP principles for regulatory acceptance and international validity. GLP compliance prevents data rejection, qualifies facilities for government tenders, and supports exports to EU, US, and GCC markets
Non-compliant labs risk sponsor withdrawals and rework costs. Vision 2030 targets $10 billion in annual pharma sales, creating demand for credible toxicology, agrochemical, and medical device testing. GLP positions KSA labs as trusted partners for multinationals like Pfizer establishing regional operations
What Is GLP Certification?
Good Laboratory Practice (GLP) forms a quality system for non-clinical studies assessing chemical, pharmaceutical, and environmental safety. It covers study planning, data recording, personnel training, equipment calibration, and QA oversight per OECD principles. Saudi regulators recognize these for SFDA drug registrations and safety assessments. Unlike ISO standards, GLP focuses on study integrity rather than testing competence, ensuring raw data traceability and audit-proof archiving. No single “GLP certificate” exists; compliance proves via successful SFDA, sponsor, or third-party inspections
How to get GLP Certification in Saudi Arabia:
Step-by-Step GLP Implementation Process
1. Gap Assessment
Evaluate existing laboratory systems against OECD GLP principles, covering Quality Assurance (QA), SOPs, data integrity, computerized systems, and equipment control. Compliance gaps and regulatory risks are identified within 1–2 weeks.
2. Documentation Development
Develop a complete GLP Quality Manual, SOPs for study conduct, deviations, archiving, equipment management, and raw data templates. All documentation is aligned with SFDA expectations and OECD GLP requirements.
3. QA Unit Setup
Establish an independent Quality Assurance (QA) unit with defined audit authority, trained personnel, and direct reporting to top management to ensure inspection credibility.
4. Training & Implementation
Conduct role-based GLP training for management, scientists, technicians, and QA teams. Implement GLP practices across active studies and validate computerized systems where applicable.
5. Internal Audits
Perform facility-based and study-based internal audits and conduct mock inspections to simulate SFDA or sponsor audits.
6. Inspection Support
Provide end-to-end support during inspections, manage corrective actions (CAPA), and ensure ongoing GLP compliance.
GLP Timeline and Costs in Saudi Arabia
GLP implementation timelines depend on laboratory size, scope of activities, and system maturity. Costs are customized based on complexity and compliance gaps.
| Lab Size | Timeline | Key Factors |
|---|---|---|
| Small Labs | 1–3 months | Basic SOPs and study controls |
| Medium CROs | 2–4 months | QA unit setup and audits |
| Large Facilities | 3–6 months | Full system and computerized validation |
Who Needs GLP in Saudi Arabia?
GLP compliance is essential for pharmaceutical testing laboratories, CROs, toxicology facilities, medical device testing labs, agrochemical laboratories, and academic research centers submitting non-clinical data to the SFDA.
Environmental laboratories supporting oil & gas projects and food safety testing labs benefit from GLP for international export compliance. Government-funded research under NEOM and emerging biotech hubs increasingly mandates GLP compliance for funding eligibility.
Medium CROs in Riyadh and large facilities in Jubail handling multinational studies rely on GLP to secure global contracts.
Key Benefits of GLP Compliance
GLP ensures SFDA approval readiness, international data acceptance, and reduced inspection risk. Laboratories report 20–30% higher project win rates after GLP implementation.
GLP strengthens governance, ensures traceable data, and builds sponsor confidence—critical for Saudi Arabia’s $65 billion healthcare and life sciences investment under Vision 2030.
| Benefit | Impact on KSA Labs |
|---|---|
| SFDA Readiness | Direct regulatory approval support |
| Global Acceptance | OECD MAD scheme validity |
| Risk Reduction | Fewer audit observations |
| Contract Wins | 20–30% higher success rate |
| Data Traceability | Complete audit trails |
GLP vs ISO 17025 – Comparison
| Aspect | GLP | ISO 17025 |
|---|---|---|
| Focus | Study integrity | Testing competence |
| Scope | Non-clinical studies | All laboratory testing |
| Quality Assurance | Mandatory QA unit | Optional audits |
| Acceptance | SFDA, EMA, FDA | Accreditation bodies |
| Archiving | Long-term raw data retention | As per lab policy |
Many laboratories in Saudi Arabia implement GLP and ISO 17025 together to achieve comprehensive regulatory and technical credibility.
Why Vertex Certifiers for GLP in Saudi Arabia?
Vertex Certifiers delivers OECD-aligned GLP frameworks with strong SFDA regulatory expertise. We provide end-to-end GLP implementation, documentation, training, mock audits, and inspection support across Riyadh, Jeddah, Dammam, Khobar, Jubail, Yanbu, and NEOM. Our remote and onsite models suit pharmaceutical companies, CROs, oil & gas laboratories, and SMEs across KSA.
GLP Certification FAQs
- Is GLP mandatory in Saudi Arabia? Yes, for SFDA non-clinical safety studies.
- Does SFDA issue GLP certificates? No, compliance is demonstrated through audits and inspections.
- Can foreign CROs operate in KSA? Yes, with GLP-compliant systems.
- What is the validity period? Ongoing, with periodic audits.
- Can GLP integrate with ISO 17025? Yes, shared systems are commonly used.
Get GLP Certified in Saudi Arabia – Free Consultation
Achieve fast, inspection-ready GLP compliance with Vertex Certifiers.
- ✔ Free GLP Gap Assessment
- ✔ Custom Documentation & Training
- ✔ Mock Inspections & Audit Support
📧 Email us: info@vertexcertifiers.com
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