Good Laboratory Practice for Non-Clinical Studies in Spain – AEMPS Framework

Regulatory Basis

Good Laboratory Practice (GLP) in Spain is implemented through Royal Decree 1369/2000 (as amended), which transposes OECD Principles of Good Laboratory Practice and EU Directive 2004/10/EC. AEMPS is the national GLP monitoring authority responsible for inspecting and certifying test facilities conducting non-clinical safety studies (toxicology, ecotoxicology, analytical, etc.) intended to support regulatory submissions for human and veterinary medicinal products. Compliance ensures that study data are reliable, reproducible, and internationally acceptable for marketing authorisation dossiers. Buenas Prácticas de Laboratorio - AEMPS

Scope of GLP Application

GLP applies to all non-clinical safety studies whose results are intended for inclusion in regulatory submissions, including:

• Preclinical toxicology (acute, subchronic, chronic, genotoxicity, carcinogenicity, reproductive toxicity).
• Safety pharmacology.
• Toxicokinetics.
• Environmental fate and effects studies for veterinary medicines.

Exemptions may apply to certain exploratory or basic research studies not intended for regulatory purposes, but facilities conducting mixed activities must clearly segregate GLP and non-GLP work.

Key GLP Principles and Requirements

• Organisation and Personnel: Defined roles for Study Director, Quality Assurance, management, and trained staff.
• Facilities and Equipment: Suitable premises, calibrated instruments, and validated computerised systems.
• Standard Operating Procedures (SOPs): Written, approved, and regularly updated SOPs for all critical procedures.
• Study Plan and Conduct: Pre-approved study plan; deviations documented and justified.
• Raw Data and Records: Complete, contemporaneous, and secure recording; archiving for at least 10 years (or longer if required).
• Quality Assurance Programme: Independent QA unit to verify compliance through audits and reporting to management.
• Test and Reference Items: Proper characterisation, storage, and handling.

Certification and Inspections

• GLP Certification: Test facilities may apply for GLP compliance statement after successful inspection by AEMPS.
• Inspections: Routine (periodic), study-specific, or for-cause inspections assess adherence to GLP principles.
• Findings Classification: Critical, major, or minor non-compliances; facilities must submit corrective action plans.
• International Acceptance: Spanish GLP certificates are recognised under OECD Mutual Acceptance of Data (MAD) framework, facilitating global regulatory submissions.

Responsibilities of Test Facilities and Sponsors

• Test facilities must maintain GLP compliance, host inspections, and report changes affecting certification.
• Sponsors ensure studies are conducted in GLP-compliant facilities and review final reports for regulatory submission.

Non-compliance may result in rejection of study data by AEMPS and other authorities, suspension of certification, or regulatory sanctions.

Practical Resources

AEMPS publishes guidance on GLP inspection procedures, application forms for certification, checklists, and FAQs. Facilities are encouraged to contact AEMPS for pre-inspection advice and to participate in national GLP working groups. This framework supports high-quality non-clinical research in Spain, contributing to the safety evaluation of medicinal products.

Complete requirements, application procedures, inspection reports, and certified facility lists are available on the AEMPS Good Laboratory Practice page. Buenas Prácticas de Laboratorio - AEMPS