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The Pillars of Good Laboratory Practice

Every building needs a sound basis, on which to erect its visible structures. Thus, Good Laboratory Practice is based on four pillars which have to support the implementation and daily observance of its Principles  [Pg.33]

It is not by sheer coincidence that management would be mentioned here in the first place as one of the pillars of GLP. It is amply borne out by experience that GLP is only as well complied with as it is supported by test facility management s inner conviction. It is not sufficient to draft a nice declaration extolling the virtues of quality in general and of GLP in particular, when in everyday work the wrong cues are given to the test facility personnel [Pg.33]

All this amounts to the requirement that it is the test facility management, who is ultimately responsible for ensuring full compliance with the GLP Principles throughout the facility as a whole. In order to deliver its responsibility, it will need some mechanism of continuous control. Therefore, an essential management responsibility is the appointment and effective organisation of an adequate number of appropriately qualified and experienced staff throughout the facility, including those specifically required to perform QA functions. [Pg.34]

And this management responsibility brings us to the second pillar of Good Laboratory Practice. [Pg.34]

Principal Investigator, as in the case of a subcontracted study, or to another Responsible Scientist , as for the preparation and assessment of histopathological slides in the specialised laboratory within his test facility, but the ultimate responsibility of the Study Director as the single central point of control cannot be delegated. The Study Director has finally to acknowledge this by signing the GLP Statement in the final report of the study he has directed. [Pg.36]


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