Template

Contract Laboratory Audit Checklist

by Gary Callahan, from the Community

10+

Evaluate third-party laboratories against GMP and GLP requirements with this contract laboratory audit template. Sections cover administration, organization and personnel, training, sample receipt and identification, facility controls and sanitation, change control, method validation and verification (USP, EP, JP, AOAC), solutions and reagents management, analytical testing practices and data review, equipment calibration and qualification (IQ, OQ, PQ) including 21 CFR 11, failure and OOS investigations, internal audits and CAPA, result reporting, and proficiency program participation. Includes scoring guidance to qualify labs based on compliance performance.

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Confirm accountability and compliance with a digital log

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Community

This community page makes available free workplace checklists and templates created by other users within the SafetyCulture community. SafetyCulture has re-published this content and where possible, has credited the original author. SafetyCulture has not verified the accuracy, reliability or suitability of any community content. You agree that your use of any of this content is in accordance with SafetyCulture’s Terms and Conditions.

Template
GCLP Audit Checklist for Clinical Laboratories
This GCLP audit checklist helps clinical laboratories assess compliance with Good Clinical Laboratory Practice. It guides auditors through organization and personnel, training and competency, SOP governance and change control, inspections and certifications such as CLIA and CAP, facility security and environmental controls, equipment qualification and maintenance, laboratory controls and validations, reagent labeling and inventories, sample receipt, shipment and storage, data handling and 21 CFR Part 11 compliance, documentation, reporting, and archival. Capture findings and define CAPA to drive continuous quality improvement.
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ISO 17025 System Audit Checklist for Asbestos Labs
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This Supplier Qualification Audit template helps organizations evaluate and approve vendors against current Good Manufacturing Practice requirements and 21 CFR 111. It covers company information, certifications, regulatory registrations, and the structure of QA and QC. The checklist spans pest control, SOPs, cleaning, preventive maintenance, employee training, quarantine procedures, lot and batch traceability, line clearance, labeling, warehouse and distribution controls, and complaint handling. It also addresses in house and external laboratory controls, method validation, calibration and maintenance, retain samples, COAs, and internal quality audits. A facility walk through guides checks across receiving, warehouse, weighing, blending and compounding, tableting and coating, packaging, maintenance, and labs to ensure consistent compliance and product quality.
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Contract Laboratory Audit Checklist

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