Good Laboratory Practices (GLP) is an instituted set of principles that help in standardising the quality and integrity of all non-clinical studies that happen in laboratories all across the world. Initially, it was introduced by the FDA which was eventually adopted by the OECD to provide a comprehensive list of guidelines to be followed.

Since then, laboratories that have adopted these principles, have been able to improve their own functioning and data reliability. In this infographic, we’ll look at the various aspects of GLP and how it’s applicable in the current scenario.

At Kewaunee International, we’re extremely particular about employing the cGLP practices in your commissioned laboratories, so if you’re looking for a complete provider for turnkey services, get in touch with us today: https://www.kewaunee.in/turnkey-services.php

Source: OECD

Aspects to consider Pointers
Standards
  • Non-clinical laboratory studies
    • 21 CFR Part 58
    • OECD GLP
Objectives
  • Data traceability
  • True reflection of results obtained
  • Internationally accepted
  • Allows replicability
Elements of GLP
  • Quality assurance
  • Analytical methods
  • Instrument qualification & calibrations
  • Chemicals & reagents
  • Sample identification & management
  • Documents records & archival
Equipment & reagents
  • Written SOPs must be present for everything included in the laboratory – right from origin and specifications, maintenance, to repairs & disposal
  • Equipment must be calibrated as per established standards
  • Chemicals must have an MSDS sheet 
  • Lighting & electrical system must be positioned appropriately and away from reagents
Organization & Personnel
  • Only qualified (education & trained) personnel must be allowed within the laboratory
  • They must wear appropriate clothing, take the required medical precautions, and also maintain the proposed standards while working
  • A defined organogram in the laboratory ensures every individual knows their responsibilities & duties within that space
Documentation
  • This needs to include everything right from sampling & retrieval to reporting analysis and submitting the data
  • You should be able to audit the data trail whenever required and all of it must be traceable
  • Examples: sampling, data validation, analytical testing, qualification, instrument SOP, reagent preparation, training records, etc.
Quality Control
  • An audit trail must be present right from receipt of consignment, sampling and handing, analysis, and storage of samples
  • An auditing committee should ensure that all records and GLP requirements are being met at regular intervals

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