JYMed mafai ona maua peptides '  API ma peptide uma atinae inumaga mo lau galuega faatino, e pei o loo i lalo:

[Peocess Atinae]

CQA

QBD

Atinae ma le naunautaiga o le faagasologa

Optimization o faagasologa

3 faaputuga le tuuina atu i le iloiloina o le tulaga talafeagai o fuafuaga e fua i luga

1-3 faaputuga tuuina fua pailate

Fa'ailoga

3 faaputuga faamaoniga tuuina

suesuega ICH Mausali

tuuina atu se faataitaiga o le falemaʻi

[Analytical Atinae]

Atinae o metotia analytical o mea ma assay fesootai

suesuega mama

Atinae o metotia analytical: GC, IC, auiliiliga acid amino, fata ions ma metotia tumama

Faavaeina o Specification

Galulue Sauniuniga Standard

Aloaia o auala analytical

[Tulafono Faatonutonu Pepa aloaia]

Aotelega o faamatalaga ma faatumuina DMF

Support faatonutonu i luma o US FDA / EDQM