JYMed siin kara peptides '  API iyo peptide dhammeeyey horumarinta qiyaasta ee aad mashruuca, sida hoos ku qoran:

[Horumarinta Shacabka]

CQA

QBD

Horumarinta iyo go'aan ka ah habka

Ayna ka mid ah geeddi-socodka

3 yaalla saarka si ay u qiimeeyaan suurtagalka in ay kor u qaaddo

1-3 yaalla saarka qiyaasta pilot

soocista

wax soo saarka 3 yaalla ansaxinta

ICH Stability waxbarasho

wax soo saarka Sample Clinical

[Horumarinta Analytical]

Horumarinta Hababka gorfaynta walax la xidhiidha iyo isku dayo ah

daraasad tan xaylka

Horumarinta Hababka gorfaynta: GC, IC, falanqaynta amino acid, udhigo counter iyo hababka nadaafadda

Dhismaha faahfaahinta

Working Standard Diyaarinta

Ansaxinta habka gorfaynta

[Documents Regulation]

Kooban xogta iyo buuxintii DMF

Taageerada Regulatory hore ee US FDA / EDQM