The Good Laboratory Practice Regulations 1999 No. 3106

SCHEDULE 2 U.K. REVISED GUIDANCE FOR THE CONDUCTOF TEST FACILITY INSPECTIONS AND STUDY AUDITS [F1 (BASED ON PART OF PART B OF ANNEX I TO THE EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE 2004/9/EC)]

Textual Amendments

F1 Words in Sch. 2 heading substituted (27.4.2004) by The Good Laboratory Practice (Codification Amendments Etc.) Regulations 2004 (S.I. 2004/994), regs. 1, 2(e)

PART II U.K. STUDY AUDITS

4.  In studies in which animals (i.e. rodents and other mammals) are used, the inspector should follow a certain percentage of individual animals from their arrival at the test facility to autopsy. They should pay particular attention to the records relating to: U.K.

• —animal body weight, food/water intake, dose formulation and administration etc.,

• —clinical observations and autopsy findings,

• —clinical chemistry,

• —pathology.