Ordinance
on Good Laboratory Practice
(OGLP)

¹ Es­tab­lish­ments that wish to have their test fa­cil­it­ies lis­ted in the re­gister (Art. 14) must ap­ply to the no­ti­fic­a­tion au­thor­ity (Art. 8).

² For each test fa­cil­ity, the ap­plic­a­tion must in­clude the fol­low­ing in­form­a­tion:

a.

name and ad­dress of the test fa­cil­ity;

b.

site plans doc­u­ment­ing the use of the in­di­vidu­al premises;

c.

or­gan­isa­tion charts doc­u­ment­ing the name and po­s­i­tion of the test fa­cil­ity man­age­ment, the per­son­nel in charge of qual­ity as­sur­ance and the study dir­ect­ors;

d.

name and ad­dress of a con­tact per­son;

e.

stand­ard op­er­at­ing pro­ced­ures for qual­ity as­sur­ance;

f.

a list of all stand­ard op­er­at­ing pro­ced­ures;

g.

the rel­ev­ant areas of ex­pert­ise;

h.

a list of all stud­ies planned over the next six months with the rel­ev­ant sched­ules;

i.

a list of all stud­ies con­duc­ted over the last six months, or still be­ing car­ried out, in the rel­ev­ant areas of ex­pert­ise.

³ On re­quest from the com­pet­ent au­thor­ity, the es­tab­lish­ments must sub­mit oth­er in­form­a­tion.

⁴ If con­di­tions in a test fa­cil­ity are sub­stan­tially mod­i­fied, the es­tab­lish­ment must sub­mit a new ap­plic­a­tion without delay. In this case the list pur­su­ant to para­graph 2 let­ter i must in­clude all stud­ies since the last in­spec­tion. In the event of any doubt, the es­tab­lish­ment must refer without delay to the no­ti­fic­a­tion au­thor­ity to de­term­ine wheth­er the modi­fic­a­tion is sub­stan­tial. The no­ti­fic­a­tion au­thor­ity gives its de­cision in agree­ment with the com­pet­ent au­thor­it­ies con­cerned.