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Sistem Kualitas


Sertifikat


Audit History


Sejarah Audit



  • 2016

    ·Finasteride dan progesteron lulus inspeksi FDA AS
    ·Progesteron lulus Inspeksi EU EDQM


  • 2019

    ·Finasteride, Progesteron, dan Budesonide lulus inspeksi FDA AS
    ·Finasteride lulus inspeksi PMDA Jepang

  • 2020

    ·Cyproterone Acetate melewati Australia TGA

  • 2021

    ·Oxcarbazepine lulus P.R. China Hubei Administrasi Obat Inspeksi

  • 2023

    ·Oxcarbazepine dan dutasteride lulus inspeksi MFDS

  • 2024

    ·Cyproterone Acetate lulus Inspeksi EDQM




Daftar Instrumen QC Utama



Instrumen Jenis Pabrikan
HPLC 1100 Agilent
1200 Agilent
1260 Agilent
1290 Agilent
LC-20At Shimadzu
LC-2030C Plus Shimadzu
Ultimate 3000 Thermofisher
Waters E2695 Perairan
GC 6890 Agilent
7697a Agilent
7890 Agilent
GC-2030AF Shimadzu
Dan Avatar 380/IS10 Nicolet
Alpha-t Bruker
UV-vis UV-2600/2000/1800 Shimadzu
AAS AA7000 Shimadzu
Polarimeter AUTOPOLS IN/ⅰS2 Rudolph
Autopol ⅳ-t Rudolph
Laser Mastersizer Mastersizer 3000 Malvern
Helos-Rodo Sympatec
Toc OC-VWP Shimadzu
HTY-DI1500 Tain
Karl-Fisher Titrator KF870 / 831/915 Metrohm
Titrator potensial 905/916 Metrohm
Detektor endotoksin PKF-96 ACC
Saringan jet udara 200l Hosokawa Alpine
pH meter PHS-3E Rex
Meteran konduktivitas DDS-307 Rex
Kabinet suhu dan kelembaban Climacell 707 Mmm
Labonce-380gs Labonce
LHH-250SD Bluepard
CTHI-150B Kontak



Audit History


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