GLP Monitoring Inspection Readiness Plan
Readiness plan for a compliance monitoring inspection, where the outcome is your standing in a system other countries rely on rather than one client confidence. Covers the authority and the scope actually inspected, master-schedule currency, a self-audit on a study that could fail, demonstrating the facility rather than paperwork about it, quality-assurance record consistency, and answering findings with cause, correction and prevention. Maps to the OECD GLP Principles and Directive 2004/10/EC.
What a template is not
A template is a document baseline to adapt inside your own quality system. SPEQ does not approve, validate, or take responsibility for what you issue from it, and using one is not evidence of compliance.
Good laboratory practice is enforced through national compliance monitoring programmes, and mutual acceptance of data between countries depends on those programmes recognising each other. The outcome of an inspection is therefore your standing in a system other countries rely on, not one client’s confidence. The scope you claim compliance for travels internationally with your data, and deciding what that scope is remains your determination.
What's Inside
How to Use It
The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.
The OECD Principles of Good Laboratory Practice set the requirements a test facility operates under, and Directive 2004/10/EC establishes the national compliance monitoring programmes through which those principles are inspected and on which mutual acceptance of data depends. Neither prescribes how a facility prepares, which study it audits itself, or how it rehearses an archive retrieval. Those choices belong to the facility. The readiness structure and the self-audit approach here are SPEQ practitioner synthesis.