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Good Laborarory Practices



 

 

GOOD LABORATORY PRACTICES

Good Laboratory Practices (GLP) covers the organizational process and conditions under which clinical field studies are conducted, monitored, recorded and reported. GLP is carried out to improve quality of data for its international acceptance. This assures the regulatory authorities that the submitted data is in accordance with the results and reliable while making decisions regarding safety assessments.

 

Operational process for analytical laboratories is greatly influenced by the GLP regulations and guidelines. GLP functions as a regulation which deals with the specific organizational structure and documents related to laboratory work in order to maintain integrity and confidentiality of the data. The entire cost of GLP based work is about 30% compared to non-GLP operations.


Requirements for GLP based operations-



  • To assign responsibility for sponsor management, study management and quality assurance.

 

  • Standard Operating Procedures must be followed.

 

  • Calibration and maintenance of instruments.

 

  • Right construction of laboratories to maintain integrity of the study.

 

  • Raw data should be processed and achieved.

 

  • Employee should be well qualified and trained as per the job assigned.

 

 

 






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