{"id":1954,"date":"2022-01-01T12:09:12","date_gmt":"2022-01-01T06:39:12","guid":{"rendered":"https:\/\/www.kewaunee.in\/blog\/?p=1954"},"modified":"2024-12-02T23:16:40","modified_gmt":"2024-12-02T17:46:40","slug":"current-good-laboratory-practices","status":"publish","type":"post","link":"https:\/\/www.kewaunee.in\/blog\/current-good-laboratory-practices\/","title":{"rendered":"Current Good Laboratory Practices"},"content":{"rendered":"

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Current Good Laboratory Practices<\/span><\/h1>[vc_column_text]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.<\/span><\/p>\n

Since then, laboratories that have adopted these principles, have been able to improve their own functioning and data reliability. In this infographic, we\u2019ll look at the various aspects of GLP and how it\u2019s applicable in the current scenario.<\/span><\/p>\n

At Kewaunee International<\/a>, we\u2019re extremely particular about employing the cGLP practices in your commissioned laboratories, so if you\u2019re looking for a complete provider for turnkey services, get in touch with us today: https:\/\/www.kewaunee.in\/turnkey-services.php<\/a><\/span><\/p>\n

Source: OECD<\/span>[\/vc_column_text][vc_row_inner][vc_column_inner][vc_column_text]<\/p>\n\n\n\n\n\n\n\n\n\n\n
Aspects to consider<\/strong><\/td>\nPointers<\/strong><\/td>\n<\/tr>\n
Standards<\/span><\/td>\n\n
    \n
  • Non-clinical laboratory studies<\/span>\n
      \n
    • 21 CFR Part 58<\/span><\/li>\n
    • OECD GLP<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/td>\n<\/tr>\n
Objectives<\/span><\/td>\n\n
    \n
  • Data traceability<\/span><\/li>\n
  • True reflection of results obtained<\/span><\/li>\n
  • Internationally accepted<\/span><\/li>\n
  • Allows replicability<\/span><\/li>\n<\/ul>\n<\/td>\n<\/tr>\n
Elements of GLP<\/span><\/td>\n\n
    \n
  • Quality assurance<\/span><\/li>\n
  • Analytical methods<\/span><\/li>\n
  • Instrument qualification & calibrations<\/span><\/li>\n
  • Chemicals & reagents<\/span><\/li>\n
  • Sample identification & management<\/span><\/li>\n
  • Documents records & archival<\/span><\/li>\n<\/ul>\n<\/td>\n<\/tr>\n
Equipment & reagents<\/span><\/td>\n\n
    \n
  • Written SOPs must be present for everything included in the laboratory \u2013 right from origin and specifications, maintenance, to repairs & disposal<\/span><\/li>\n
  • Equipment must be calibrated as per established standards<\/span><\/li>\n
  • Chemicals must have an MSDS sheet\u00a0<\/span><\/li>\n
  • Lighting & electrical system must be positioned appropriately and away from reagents<\/span><\/li>\n<\/ul>\n<\/td>\n<\/tr>\n
Organization & Personnel<\/span><\/td>\n\n
    \n
  • Only qualified (education & trained) personnel must be allowed within the laboratory<\/span><\/li>\n
  • They must wear appropriate clothing, take the required medical precautions, and also maintain the proposed standards while working<\/span><\/li>\n
  • A defined organogram in the laboratory ensures every individual knows their responsibilities & duties within that space<\/span><\/li>\n<\/ul>\n<\/td>\n<\/tr>\n
Documentation<\/span><\/td>\n\n
    \n
  • This needs to include everything right from sampling & retrieval to reporting analysis and submitting the data<\/span><\/li>\n
  • You should be able to audit the data trail whenever required and all of it must be traceable<\/span><\/li>\n
  • Examples: sampling, data validation, analytical testing, qualification, instrument SOP, reagent preparation, training records, etc.<\/span><\/li>\n<\/ul>\n<\/td>\n<\/tr>\n
Quality Control<\/span><\/td>\n\n