GLP regulations are international standards relevant for research, development and QC laboratories used for pre-clinical trials and studies, planned and performed

The studies being performed n a certified GLP laboratory should be monitored, recorded, then archived. The GLP regulations were published by the US Food and Drug Administration in 1976.

The quality aspects of GLP are defined by its capability to repeatedly provide the same testing and analysis service in the same specifications and levels. GLP includes the capability to protect the data integrity and quality of laboratory data. GLP Implementation is being performed based on written working procedures (SOP’s) and documentation of the work as it is being done.

The purpose of GLP is to support the development of quality and validated testing data used to verify the safety and compatibility to product specification. GLP regulation requirements cover several subjects, which include:

  • General requirements- Qualified personnel, adequate resources, Sanitation, employee health verification, garment, data storage
  • Facilities requirements-appropriate size, contamination separation, construction materials, sample storage
  • Equipment requirements- operational accessibility, efficiency, suitable for production rate, routinely maintained & calibrated, validation for equipment, validation for testing methods
  • SOP’s -Testing, sampling, data documentation, sample storage, equipment maintenance & calibration, labeling of samples and materials, protocol indicating test objectives & methods, final report of results, records retention, deviations investigations, out of specifications.

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