GCLP (Good clinical laboratory practice) Guidance

The TDR/WHO Good Clinical Laboratory Practice (GCLP) guidance responds to the need for a unified, internationally applicable standard for laboratories processing specimens from clinical trials, particularly in disease endemic and resource limited settings. It explains how to apply Good Laboratory Practice concepts to clinical trial sample analysis in a way that also fulfils Good Clinical Practice requirements, with the aim of ensuring subject safety, data integrity and global acceptability of trial results.
The document is provided as a single PDF with its core containing a rich glossary and a series of numbered sections covering key elements of laboratory quality systems. The scope recommends adoption of the framework by any organisation analysing samples generated by a clinical trial, including pharmaceutical company laboratories, contract research organisations, central laboratories, pharmacogenetic laboratories, hospital laboratories, clinics, investigator sites and specialised analytical services. 

The introduction clarifies the relationship between Good Clinical Practice, Good Laboratory Practice and Good Clinical Laboratory Practice, and emphasises that the framework is intended to be interpreted flexibly across diverse analytical disciplines while assuring the quality of every aspect of the work.

The main content is organised into practical sections with sub headings:

• Organisation and personnel: responsibilities of trial facility management, the Analytical Project Manager and trial staff, including staffing, qualifications, training, health and safety, quality audit and archiving.
• Facilities: requirements for trial facilities, archive facilities and waste disposal.
• Equipment, materials and reagents: fitness for purpose, maintenance, calibration, service schedules and labelling.
• Standard operating procedures: development, approval, review, availability and application to trial supplies, equipment, record keeping, reporting, trial materials and storage, analysis procedures and quality processes.
• Planning of the work: analytical plan requirements, including identification of work, sponsor and facility details, dates, analytical methods, logistics, records and quality audit, as well as management and documentation of amendments.
• Sub contracting: conditions for placing work with subcontractors and ensuring they work in accordance with GCLP and trial requirements.
• Trial materials: receipt, chain of custody, logistics, storage and monitoring of controlled conditions.
• Conduct of the work: data recording rules, handling of changes, validation and control of computer systems, method validation, processing of trial materials, repeat analysis and safety considerations.
• Reporting results: structure and content of analytical reports and analytical results, issuance, corrections and amendments.
• Quality control and quality audit: internal quality control procedures, participation in external proficiency schemes and independent quality audits with corrective and preventive actions.
• Storage and retention of records: retention of analytical plans, data, reports, qualification records, maintenance records and quality control documentation, and use of contract archives where needed.
• Confidentiality: procedures to maintain subject confidentiality, protect study blinding and safeguard sponsors’ proprietary information.

For investigator initiated clinical studies, this guidance offers a comprehensive, practice oriented framework to design and assess laboratory quality systems, analytical plans, sample management, data handling and archiving so that they meet internationally recognised GCLP expectations. A practical way to begin is to review the scope and introduction to confirm relevance, then work through the sections on organisation and personnel, analytical planning, trial materials, conduct of work and reporting as a checklist against existing laboratory procedures and quality documentation.