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Ordinance
on Good Laboratory Practice
(OGLP)

English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.

of 18 May 2005 (Status as of 1 December 2012)

Art. 10 Reports on inspections and study audits

1 The com­pet­ent au­thor­ity shall provide the es­tab­lish­ment with the draft of the in­spec­tion re­port and al­low it an ap­pro­pri­ate peri­od in which to state its po­s­i­tion there­on. On re­ceipt of a re­sponse from the es­tab­lish­ment or on ex­piry of the peri­od, the au­thor­ity shall pass the in­spec­tion re­port to the no­ti­fic­a­tion au­thor­ity.

2 The com­pet­ent au­thor­ity shall pass the re­port on the study audit to the no­ti­fic­a­tion au­thor­ity.

3 The no­ti­fic­a­tion au­thor­ity shall de­cide:

a.
on the basis of the in­spec­tion re­port, wheth­er the test fa­cil­ity is op­er­at­ing ac­cord­ing to the GLP Prin­ciples;
b.
on the basis of the study audit re­port, wheth­er the study was car­ried out ac­cord­ing to the GLP Prin­ciples;

4 The pro­vi­sions on study audits also ap­ply to stud­ies audited dur­ing an in­spec­tion.