Ordinance
on Licensing in the Medicinal Products Sector
(Medicinal Products Licensing Ordinance, MPLO)

¹ Any per­son ap­ply­ing to the Swiss Agency for Thera­peut­ic Products (Swiss­med­ic) for a man­u­fac­tur­ing li­cence must prove that:

a.

a sys­tem to en­sure the phar­ma­ceut­ic­al qual­ity of medi­cin­al products is in op­er­a­tion and that the com­pany man­age­ment and staff in the in­di­vidu­al de­part­ments con­cerned take an act­ive part in such a sys­tem;

b.

each de­part­ment has a suf­fi­cient num­ber of qual­i­fied and com­pet­ent staff mem­bers to en­able it to achieve its qual­ity tar­gets;

c.

a Re­spons­ible Per­son as de­scribed in Art­icles 5 and 6 is avail­able;

d.

the fa­cil­it­ies are or­gan­ised in an ap­pro­pri­ate way;

e.

the fa­cil­it­ies are de­signed, struc­tured, main­tained and mod­ern­ised reg­u­larly to guar­an­tee the safe man­u­fac­ture of medi­cin­al products and the premises and equip­ment that can in­flu­ence the qual­ity of the medi­cin­al products are qual­i­fied for their pur­pose;

f.

a doc­u­ment­a­tion sys­tem is avail­able to provide the work­ing in­struc­tions, pro­cess de­scrip­tions and pro­to­cols of the rel­ev­ant man­u­fac­tur­ing pro­ced­ures;

g.

the man­u­fac­tur­ing, test­ing and clean­ing pro­ced­ures are val­id­ated;

h.

qual­ity con­trol is sep­ar­ate from man­u­fac­ture;

i.

the ob­lig­a­tions de­scribed in Art­icles 4 and 7 and in re­la­tion to the man­u­fac­ture of labile blood products and the ob­lig­a­tions in Art­icles 28–38 are met.

² The work of all per­sons oc­cupy­ing key po­s­i­tions in the com­pany must be set out in job de­scrip­tions and their hier­arch­ic­al po­s­i­tions set out in or­gan­isa­tion­al charts.

³Swiss­med­ic may spe­cify fur­ther tech­nic­al re­quire­ments and de­tails.