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Regulatory Guidance

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“Good Laboratory Practice (GLP) embodies a set of principles that provides a framework within which laboratory studies are planned, performed, monitored, recorded, reported and archived. These studies are undertaken to generate data by which the hazards and risks … can be assessed for pharmaceuticals, agrochemicals, veterinary medicines, industrial chemicals, cosmetics, food and feed additives and biocides. GLP helps assure regulatory authorities that the data submitted are a true reflection of the results obtained during the study and can therefore be relied upon when making risk/safety assessments.”


- Medicines and Healthcare products Regulatory Agency (MHRA)


GLP is required: GLP is not required:
  • Non clinical safety studies for development of drugs, small molecules, biologics, vaccines, gene therapeutic agents, etc
  • Clinical trial sample DNA sequencing
  • Agricultural pesticide development
  • Development of toxic chemicals
  • Food control (food additives)
  • Test substance with regard to explosive hazards
  • Basic research
  • Studies to develop new analytical methods
  • Chemical tests used to derive the specifications of a marketed food product

Please click below to go to the guidelines pages from authorities:
Link to FDA regulations
Link to OECD
Link to IFCC
Link to WHO
Link to ICH

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