OECD GLP compliance consulting for safety studies regulators can rely on.

What it is

What are the OECD Principles of Good Laboratory Practice?

The OECD Principles of Good Laboratory Practice (GLP) are a quality system for the organisational process and conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, reported and archived. They are owned and published by the Organisation for Economic Co-operation and Development, and they sit behind the safety data that sponsors submit to regulatory authorities when a product or substance is assessed.

GLP is about the study, not the result. It does not say which test to run; it makes sure a reviewer can later reconstruct who did what, with which item and under which procedure, from the raw data and archived materials. The OECD links GLP to the Mutual Acceptance of Data system, under which safety data generated in line with the Principles in one adhering country can be accepted in others, as the OECD sets out in its Council instruments.

Current text. The OECD Principles of Good Laboratory Practice currently in force, read with the OECD's consensus and advisory documents on applying them, including computerised systems, multi-site studies, short-term studies, field studies, test items and quality assurance.

Who it is for

Who needs OECD GLP compliance?

GLP matters to any test facility, in-house or contract, whose non-clinical safety studies are submitted to a regulator that expects them to be conducted under GLP. Laboratories come to Sterling from four directions:

• A sponsor makes GLP a condition of the study contract. Sponsors want studies placed with a facility the national authority already monitors, and ask for your status before signing.
• A tender or framework requires GLP studies. Tenders for toxicology, ecotoxicology or analytical work specify GLP; the system has to exist before the bid.
• A regulator will receive the data. A dossier is heading to an authority that reviews the GLP status of the studies in it, and the facility has never been through a GLP inspection.
• A group wants one approach across its laboratories. Several sites, or a multi-site study, need consistent roles, procedures and archiving.

Requirements

What are the main OECD GLP requirements?

The Principles define the responsibilities of test facility management, the study director and quality assurance, and then set out requirements under a series of headings. Each heading is summarised below in plain language; the gap analysis checks your facility against the OECD text itself.

• Test facility organisation and personnel: management responsibilities, the appointment and authority of the study director, and qualified, trained staff in sufficient numbers.
• Quality assurance programme: a quality assurance function independent of study conduct, with its own inspections, audits and statements on study reports.
• Facilities: suitable size, construction and separation for test systems, test and reference items, archives and waste.
• Apparatus, material and reagents: equipment that is fit for use, inspected, cleaned, maintained and calibrated, and reagents that are labelled and controlled.
• Test systems: appropriate conditions, housing, handling and records for physical, chemical and biological test systems.
• Test and reference items: receipt, handling, sampling, storage and characterisation, with records that tie each item to each study.
• Standard operating procedures: written, approved procedures for routine activities, available where the work is done.
• Performance of the study: an approved study plan for every study, conducted as planned, with deviations recorded and raw data captured promptly and accurately.
• Reporting of study results: a final report for each study, signed by the study director, stating the extent of compliance with the Principles.
• Storage and retention of records and materials: secure archives for study plans, raw data, reports, specimens and samples, under a named archivist.

Compliance route

How does a test facility achieve OECD GLP compliance?

There is no GLP certificate. A facility puts the Principles into practice, then the national GLP compliance monitoring authority of its country inspects it under its programme. Sterling prepares the facility; the authority's monitoring and decisions are its own.

1. 01
   Define the studies and where the data will go.Agree the study types, test systems, sites and sponsors in scope, and identify the national authority that monitors facilities in your country.
2. 02
   Gap analysis: review the facility against the Principles.Organisation, quality assurance, facilities, equipment, test systems, items, procedures, study conduct, reporting and archives, with actions, owners and dates.
3. 03
   Build the system and run it on real work.Appoint study directors and quality assurance, write the procedures, set up the master schedule and archive, train staff and conduct studies under the new system.
4. 04
   Test it with quality assurance and a mock inspection.Study-based, facility-based and process-based reviews, a mock inspection by us, and every finding closed with evidence.
5. 05
   Complete the national authority's inspection.Follow the authority's procedure, host its inspection, respond to its findings by its deadline, then keep the system running for its continued monitoring under Sustain™.

Check the route before you sign. GLP status comes from a national compliance monitoring programme, not from a consultant or a certification body. The OECD publishes the list of national GLP compliance monitoring programmes that participate in the Mutual Acceptance of Data; confirm that your country's programme is on it and ask the authority directly about its procedure.

Cost

How much does OECD GLP compliance cost?

An analytical laboratory adding GLP to an existing quality system is a different programme from a new toxicology facility. Every proposal shows each component, with an all-inclusive proposal for our part.

Timeline

How long does OECD GLP compliance take?

Plan in months. The system has to run on real studies, reviewed by quality assurance, before an inspector has anything to examine, and the authority schedules inspections on its own calendar. As an estimate, a facility starting from a working laboratory quality system is typically ready for a first inspection in 9 to 18 months; the proposal sets the figure for your scope.

Your engagement

What your OECD GLP engagement includes

Your engagement follows Sterling OS™. You choose one of two support levels: Design™, where your staff build the system with our guidance and templates, or Drive™, where our consultants manage the work with your people. After the authority's inspection, Sustain™ keeps quality assurance, training and archives current, and Automate™ is Effivity, running the system from the first workshop. Sterling does not inspect, certify or grant GLP status; that is the national authority's role.

• Scope, gap analysis and plan

  Study types, sites and responsibilities agreed before work starts.

• Procedures and study templates

  Standard operating procedures, study plan and final report formats built with your staff.

• Effivity ISO & GRC software

  Documents, training, equipment and findings in one place, included with the engagement at no additional cost.

• Training for everyone

  Internal auditor training for your quality assurance staff, as applicable to your standard, and preferential Sterling Academy access, including complimentary awareness training for your people as part of the engagement.

• Quality assurance review and mock inspection

  Conducted or facilitated as agreed, with findings closed before the authority visits.

• Inspection readiness and support

  Preparation for the national authority's inspection and help responding to its findings.

Compliance monitoring and all decisions remain with the national GLP compliance monitoring authority.

Often combined with

Standards organisations pair with OECD GLP

• 21 CFR Part 11 / EU Annex 1121 CFR Part 11 and Annex 11 compliance for GxP systems: requirements, validation, audit trails and e-signatures, with evidence ready for FDA and EU inspectors.
• ADHICS (Abu Dhabi)ADHICS compliance consulting for DoH-regulated healthcare entities in Abu Dhabi: patient information, systems and devices protected, with audit-ready evidence.
• CAP accreditationCAP accreditation readiness for laboratories: checklist gap analysis, method records, self-inspection and peer inspection support.
• EU IVDR 2017/746EU IVDR compliance consulting for IVD manufacturers: performance evidence, QMS, traceability and post-market follow-up prepared for your notified body.
• EU MDR 2017/745EU MDR compliance consulting for CE marking: QMS, technical documentation, traceability and post-market surveillance prepared for your notified body.
• FDA QMSR (21 CFR 820)FDA QMSR compliance consulting for device makers selling in the US: a quality management system ready for FDA inspection, wherever you manufacture.