Ordinance
on Good Laboratory Practice
(OGLP)

¹ This Or­din­ance lays down the Prin­ciples of Good Labor­at­ory Prac­tice (GLP) as the qual­ity stand­ard for stud­ies, and reg­u­lates com­pli­ance mon­it­or­ing.

² The Or­din­ance aims to:

a.

en­sure that test data are re­pro­du­cible;

b.

pro­mote in­ter­na­tion­al ac­cept­ance of tests con­duc­ted in Switzer­land in or­der to avoid du­plic­ate test­ing.

The Or­din­ance ap­plies to non-clin­ic­al stud­ies of sub­stances, pre­par­a­tions and art­icles (test items) that:

a.

serve to ob­tain data on the prop­er­ties of a test item and its safety with re­spect to hu­man health and the en­vir­on­ment; and

b.

provide data to be sub­mit­ted to the au­thor­it­ies in view of a re­gis­ter­ing or li­cens­ing pro­ced­ure.

¹ In this Or­din­ance:

a.

Good Labor­at­ory Prac­tice (GLP) means a qual­ity sys­tem con­cerned with the or­gan­isa­tion­al pro­cess and the con­di­tions un­der which stud­ies are planned, per­formed, mon­itored, re­cor­ded, archived and re­por­ted.

b.⁴

areas of ex­pert­isemeans stud­ies con­duc­ted in the fol­low­ing cat­egor­ies:

1.

phys­ic­al-chem­ic­al test­ing,

2.

tox­icity stud­ies,

3.

muta­gen­i­city stud­ies,

4.

en­vir­on­ment­al tox­icity stud­ies on aquat­ic and ter­restri­al or­gan­isms,

5.

stud­ies on be­ha­viour in wa­ter, soil and air; bioac­cu­mu­la­tion

6.

residue stud­ies,

7.

stud­ies on ef­fects on meso­cosms and nat­ur­al eco­sys­tems,

8.

ana­lyt­ic­al and clin­ic­al chem­istry test­ing,

9.

oth­er stud­ies, spe­cify;

c.

study audit means an audit of a study to veri­fy that its data, re­cords, re­ports and oth­er ele­ments com­ply with GLP Prin­ciples;

d.

test fa­cil­ity means the per­sons, premises and op­er­a­tion­al unit(s) that are ne­ces­sary for con­duct­ing stud­ies; for multi-site stud­ies con­duc­ted at more than one site, the test fa­cil­ity com­prises the site at which the study dir­ect­or is loc­ated and all in­di­vidu­al test sites that in­di­vidu­ally or col­lect­ively may be con­sidered as such.

² Fur­ther terms rel­ev­ant to GLP are defined in An­nex 1.

¹ The prin­ciples of GLP are lis­ted in An­nex 2.

² The Fed­er­al Of­fice of Pub­lic Health (FOPH)⁵, the Fed­er­al Of­fice for the En­vir­on­ment (FOEN) and Swiss­med­ic (Swiss Agency for Thera­peut­ic Products) may is­sue joint guidelines on the in­ter­pret­a­tion of GLP Prin­ciples. In do­ing so they must take ac­count of in­ter­na­tion­ally re­cog­nised reg­u­la­tions.

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.

¹ After re­ceiv­ing an ap­plic­a­tion, the com­pet­ent au­thor­ity shall in­spect the test fa­cil­it­ies on site. Dur­ing this in­spec­tion, the au­thor­ity checks in par­tic­u­lar wheth­er the pro­ced­ures, op­er­at­ing pro­ced­ures and data ob­tained re­spect the prin­ciples of GLP.

² There­after, the au­thor­ity shall in­spect the test fa­cil­it­ies again every two to three years. Pri­or to each in­spec­tion the au­thor­ity shall re­quest in­form­a­tion pur­su­ant to Art­icle 5 para­graph 2. The list pur­su­ant to Art­icle 5 para­graph 2 let­ter i must in­clude all stud­ies con­duc­ted since the last in­spec­tion. The com­pet­ent au­thor­ity may re­quest fur­ther data.

³ If there is suf­fi­cient reas­on to as­sume that a test fa­cil­ity does not com­ply with the GLP Prin­ciples, the com­pet­ent au­thor­ity may con­duct an in­spec­tion without delay.

⁴ The com­pet­ent au­thor­ity shall pro­duce a re­port on each in­spec­tion.

¹ The com­pet­ent au­thor­ity shall con­duct a study audit on its own ini­ti­at­ive or at the re­quest of an­oth­er com­pet­ent Swiss or for­eign au­thor­ity if:

a.

there is suf­fi­cient reas­on to as­sume that a test fa­cil­ity did not com­ply with GLP Prin­ciples when con­duct­ing cer­tain stud­ies;

b.

the res­ults of a par­tic­u­lar study are of vi­tal im­port­ance for as­sess­ing hu­man or en­vir­on­ment­al safety.

² If after com­ple­tion of the study audit the com­pet­ent au­thor­ity con­cludes that the audited study did not com­ply with GLP Prin­ciples, it may carry out an in­spec­tion.

³ The com­pet­ent au­thor­ity may also carry out a study audit as part of an in­spec­tion.

⁴ The com­pet­ent au­thor­ity shall pro­duce a re­port on each in­spec­tion.

¹ The no­ti­fic­a­tion au­thor­ity in ac­cord­ance with Art­icle 4 para­graph 1 let­ter h of the ChemA shall co­ordin­ate the con­duct of in­spec­tions and of study audits and, in agree­ment with the com­pet­ent au­thor­it­ies, pro­duce de­cisions on con­form­ity with the prin­ciples of GLP.

2 The fol­low­ing au­thor­it­ies are com­pet­ent to carry out in­spec­tions and study audits:

a.

the FOPH and Swiss­med­ic for stud­ies of tox­ic­o­lo­gic­al prop­er­ties;

b.

the FOEN for stud­ies of eco­tox­o­lo­gic­al prop­er­ties or of en­vir­on­ment­al be­ha­viour of the test items;

c.

the FOPH, the FOEN or Swiss­med­ic after mu­tu­al agree­ment for stud­ies of all oth­er prop­er­ties.

³ Where ne­ces­sary the au­thor­it­ies may del­eg­ate tasks to each oth­er, or call in spe­cial­ists. They may del­eg­ate all or part of the tasks and com­pet­ences with which they are en­trus­ted by vir­tue of this Or­din­ance to ap­pro­pri­ate pub­lic cor­por­a­tions or in­di­vidu­als. The FOPH and Swiss­med­ic may only del­eg­ate the con­duct of in­spec­tions and study audits.

¹ The au­thor­ity shall carry out in­spec­tions and study audits ac­cord­ing to the guidelines in Sec­tions A and B of An­nex I of European Dir­ect­ive 2004/9/EC of the Par­lia­ment and of the Coun­cil of 11 Feb­ru­ary 2004⁶.

² On re­quest, the es­tab­lish­ment must sub­mit to the au­thor­it­ies all doc­u­ments and all oth­er evid­ence re­quired to as­sess its com­pli­ance with GLP Prin­ciples.

³ The au­thor­it­ies must be al­lowed to ac­cess the test fa­cil­it­ies at all times.

⁴ If an es­tab­lish­ment with test fa­cil­it­ies has been ac­cred­ited by the Swiss Ac­cred­it­a­tion Ser­vice pur­su­ant to Art­icle 14 of the Or­din­ance of 17 June 1996⁷ on Ac­cred­it­a­tion and Iden­ti­fic­a­tion, the au­thor­ity shall take these res­ults in­to ac­count.

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.

The no­ti­fic­a­tion au­thor­ity shall in­form the com­pet­ent au­thor­it­ies of planned in­spec­tions and study audits, and of de­cisions pur­su­ant to Art­icle 10.

¹ An es­tab­lish­ment must im­me­di­ately no­ti­fy the no­ti­fic­a­tion au­thor­ity if:

a.

it changes its name or ad­dress;

b.

one of its test fa­cil­it­ies changes its name or ad­dress;

c.

one of its test fa­cil­it­ies is no longer will­ing to com­ply with GLP Prin­ciples.

d.

there are changes in re­spons­ib­il­it­ies at the level of the man­age­ment of the test fa­cil­ity or of the qual­ity as­sur­ance unit.

e.

it in­tends to ex­tend the area of ex­pert­ise.

¹ For any study that must be car­ried out ac­cord­ing to the prin­ciples of GLP, it is ne­ces­sary in the pro­ced­ure of no­ti­fic­a­tion or au­thor­isa­tion:

to show that the study was car­ried out in a test fa­cil­ity re­gistered, at the time when the study was car­ried out, in the Swiss re­gister of test fa­cil­it­ies that com­ply with the prin­ciples of GLP;

to present a study re­port in which the study dir­ect­or con­firms, in one of the Swiss na­tion­al lan­guages or in Eng­lish, that the study was car­ried out in com­pli­ance with the prin­ciples of GLP.

² If the study was car­ried out in a coun­try oth­er than Switzer­land, in ad­di­tion to the study re­port, an ex­tract from the for­eign re­gister or a con­firm­a­tion from the for­eign au­thor­ity must be sub­mit­ted prov­ing that the test fa­cil­ity was in­cluded in the of­fi­cial mon­it­or­ing pro­gramme at the time the study was car­ried out. In the case of coun­tries that are not mem­bers of the Or­gan­isa­tion for Eco­nom­ic Co-op­er­a­tion and De­vel­op­ment (OECD), the no­ti­fic­a­tion au­thor­ity may re­quest oth­er doc­u­ments that it con­siders ne­ces­sary to eval­u­ate com­pli­ance with the prin­ciples of GLP.

³ If jus­ti­fied by the cir­cum­stances, and in par­tic­u­lar if the res­ults of the study are very im­port­ant, or if there is doubt wheth­er the prin­ciples of GLP have been re­spec­ted, a fed­er­al ex­ec­ut­ive au­thor­ity may ask the no­ti­fic­a­tion au­thor­ity to have a study audit car­ried out.

¹ The no­ti­fic­a­tion au­thor­ity shall main­tain a re­gister of all es­tab­lish­ments with their in­spec­ted test fa­cil­it­ies and their audited stud­ies.

² The no­ti­fic­a­tion au­thor­ity shall enter the data in the re­gister as soon as the form­al de­cision has been made con­firm­ing con­form­ity of the test fa­cil­ity with the prin­ciples of GLP.

³ The no­ti­fic­a­tion au­thor­ity shall provide the es­tab­lish­ment with a con­firm­a­tion stat­ing, in one of the of­fi­cial Swiss lan­guages or in Eng­lish, that its test fa­cil­it­ies are lis­ted in the re­gister.

⁴ The no­ti­fic­a­tion au­thor­ity shall reg­u­larly pub­lish, in an ap­pro­pri­ate way, a list of the test fa­cil­it­ies that work ac­cord­ing to the prin­ciples of GLP.

⁵ If the prin­ciples of GLP are no longer re­spec­ted, the test fa­cil­ity shall be re­moved from the list men­tioned in para­graph 4.

The re­gister shall spe­cify:

a.

the name and ad­dress of the es­tab­lish­ment and of its test fa­cil­it­ies;

b.

the type and date of in­spec­tion and the rel­ev­ant areas of ex­pert­ise;

c.

the date of the study audit and iden­ti­fic­a­tion of the study;

d.

the de­cision re­l­at­ive to com­pli­ance with GLP Prin­ciples;

e.

the date of the de­cision or of the no­ti­fic­a­tion that the rel­ev­ant test fa­cil­ity no longer com­plies with GLP Prin­ciples.

¹ If in the course of an in­spec­tion, the com­pet­ent au­thor­ity as­cer­tains that a test fa­cil­ity fails to com­ply with GLP Prin­ciples to the ex­tent that the re­li­ab­il­ity of study res­ults is no longer guar­an­teed, and that in con­sequence these res­ults may gen­er­ate er­ro­neous con­clu­sions re­lat­ing to hu­man and en­vir­on­ment­al safety, it must im­me­di­ately in­form the no­ti­fic­a­tion au­thor­ity.

² The no­ti­fic­a­tion au­thor­ity must in­form the fed­er­al ex­ec­ut­ive au­thor­it­ies re­spons­ible for eval­u­at­ing no­ti­fic­a­tions or au­thor­isa­tions for sub­stances and pre­par­a­tions.

¹ The com­pet­ent au­thor­it­ies may trans­mit con­fid­en­tial data only to:

a.

each oth­er;

b.

the fed­er­al ex­ec­ut­ive au­thor­it­ies pur­su­ant to Art­icle 16 para­graph 2;

c.

for­eign GLP au­thor­it­ies, if this is provided for by agree­ments un­der in­ter­na­tion­al law or by fed­er­al le­gis­la­tion.

² Un­der no cir­cum­stances are the entries in the re­gister pur­su­ant to Art­icle 15 con­fid­en­tial.

¹ De­pend­ing on the area of com­pet­ence (Art. 8), the FOPH, the FOEN and Swiss­med­ic shall rep­res­ent Switzer­land on GLP-re­lated is­sues in deal­ings with au­thor­it­ies and in­sti­tu­tions abroad, and with in­ter­na­tion­al or­gan­isa­tions.

² The FOEN shall co-or­din­ate deal­ings with the Or­gan­isa­tion for Eco­nom­ic Co-op­er­a­tion and De­vel­op­ment (OECD) at na­tion­al level. Each year it shall sup­ply the OECD and the OECD mem­ber states with a list of in­spec­ted es­tab­lish­ments with their test fa­cil­it­ies and con­duc­ted study audits, and no­ti­fy them of es­tab­lish­ments that are guilty of ser­i­ous non-com­pli­ance with GLP Prin­ciples.

¹ De­cisions made and con­firm­a­tions de­livered be­fore this Or­din­ance comes in­to force re­main val­id un­til they are re­placed by doc­u­ments after the next in­spec­tion.

² Re­quests made ac­cord­ing to the pre­vi­ous le­gis­la­tion and still be­ing pro­cessed by the GLP au­thor­it­ies shall be passed on to the no­ti­fic­a­tion au­thor­ity when this Or­din­ance comes in­to force.

This Or­din­ance comes in­to force on 1 Au­gust 2005.